| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K073284 |
11/21/2007 |
AIR-FLOW MASTER STANDARD |
(EMS SA) ELECTRO MEDICAL SYSTEMS |
SUSAN M BONAPACE |
| K073296 |
11/23/2007 |
TEMPXN28 |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
| K073322 |
11/26/2007 |
FOX 1-980, FOX Q-1064, FOX-Q-810 |
A.R.C. LASER GMBH |
KIRSTEN H PAULSON |
| K070223 |
01/24/2007 |
AUDIT MICROCV LIPIDS LINEARITY SET (LOW) |
AALTO SCIENTIFIC LTD. |
ALAN VEKICH |
| K073202 |
11/13/2007 |
ARDIS SPACER |
ABBOTT SPINE, INC. |
MARITZA ELIAS |
| K070225 |
01/24/2007 |
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE |
ABIOMED, INC. |
ROBERT T KUNG |
| K073120 |
11/05/2007 |
ACCIN PATELLOFEMORAL SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITNITSKY |
| K073276 |
11/21/2007 |
IONTOPHORESIS SYSTEM |
ACCLARENT, INC. |
KERI YEN |
| K073343 |
11/28/2007 |
ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
| K070296 |
01/31/2007 |
VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM |
ACE VISION GROUP |
IAN GORDON |
| K070289 |
01/30/2007 |
ACQUASEAL BENZ |
ACQUAMED TECHNOLOGIES, INC. |
HUGH PALMER |
| K070028 |
01/03/2007 |
CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER |
ACTHERM, INC. |
RICHARD HSIEH |
| K070045 |
01/04/2007 |
ZIRBLANK-PS AND ZIRBLANK-FS |
ACUCERA, INC. |
KYUNG-BIN LEE |
| K070051 |
01/04/2007 |
ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
| K070197 |
01/22/2007 |
ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
| K073233 |
11/15/2007 |
ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS |
ADVANCED BIO-SURFACES, INC. |
PHILIP B JARVI |
| K073197 |
11/13/2007 |
SILVER ANTIMICROBIAL WOUND GEL |
ADVANCED MEDICAL SOLUTIONS LIMITED |
CLAIRE RYAN |
| K073170 |
11/09/2007 |
R-PORT II LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
MARY MCNAMARA-CULLINANE |
| K070158 |
01/17/2007 |
R-PORT LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
TANYA KAVANAGH |
| K070168 |
01/18/2007 |
N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C |
AEARO COMPANY |
ANN L PHILLIPS |
| K070178 |
01/19/2007 |
AESCULAP RESORBABLE PIN, MODEL FR735 |
AESCULAP IMPLANT SYSTEM, INC. |
MATTHEW M HULL |
| K073168 |
11/09/2007 |
AESCULAP PRIMELINE CONTAINER LTD. |
AESCULAP, INC. |
KATHY A RACOSKY |
| K070238 |
01/25/2007 |
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM |
AGA MEDICAL CORP. |
DAVID D COX |
| DEN070009 |
01/30/2007 |
MAMMAPRINT |
AGENDIA BV |
GUILDO BRINK |
| K073271 |
11/21/2007 |
ORTHOGON |
AGFA HEALTHCARE CORPORATION |
TOM HOLBROOK |
| K073227 |
11/15/2007 |
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300 |
AIIA COMMUNICATION INC. |
DANIEL KAMM |
| K073223 |
11/15/2007 |
S-TEST C02 |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DAVID SLAVIN |
| K070120 |
01/12/2007 |
AUTOVENT MODEL 4000 |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K073171 |
11/09/2007 |
RESUSCITATION TIMER, MODEL L770-CPR |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K070004 |
01/03/2007 |
ACCENT |
ALMA LASERS LTD. |
ANNE WORDEN |
| K070161 |
01/17/2007 |
QUATTRO CATHETER MODEL IC4593 |
ALSIUS CORP. |
KENNETH A COLLINS |
| K073125 |
11/06/2007 |
VALEO VBR |
AMEDICA CORP. |
ADAM HERDER |
| K070232 |
01/24/2007 |
ECG CABLES, TRUNK AND PATIENT LEAD WIRES |
AMERICAN I.V. PRODUCTS, INC. |
JOHN TAYLOR |
| K070065 |
01/08/2007 |
AMS SINGLE INCISION SLING SYSTEM (SIS-0) |
AMERICAN MEDICAL SYSTEMS, INC. |
BRAD ONSTAD |
| K073219 |
11/15/2007 |
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 |
AMERICAN MEDICAL SYSTEMS, INC. |
MONA INMAN |
| K070088 |
01/09/2007 |
ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM |
APEX BIOTECHNOLOGY CORP. |
THOMAS Y.S. SHEN |
| K073137 |
11/07/2007 |
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 |
APEX BIOTECHNOLOGY CORP. |
THOMAS Y.S. SHEEN |
| K073265 |
11/20/2007 |
APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM |
APIERON, INC. |
RICHARD LOTTI |
| K073149 |
11/08/2007 |
MENISCAL CINCH |
ARTHREX, INC. |
SALLY FOUST |
| K070227 |
01/24/2007 |
OPUS MAGNUM PI KNOTLESS FIXATION DEVICE |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K070034 |
01/03/2007 |
REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES |
ASCENT HEALTHCARE SOLUTIONS |
KATIE BRAY |
| K070036 |
01/03/2007 |
REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES |
ASCENT HEALTHCARE SOLUTIONS |
KATIE BRAY |
| K070059 |
01/05/2007 |
REPROCESSED TROCARS |
ASCENT HEALTHCARE SOLUTIONS |
MOIRA BARTON |
| K070069 |
01/08/2007 |
ZIPPREP ELECTRODE |
ASPECT MEDICAL SYSTEMS, INC. |
VIKRAM VERMA |
| K073258 |
11/20/2007 |
ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K070192 |
01/22/2007 |
ATRIUM PROLITE ULTRA S MESH |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
| K070253 |
01/26/2007 |
AXYA SUTURE WELDING SYSTEM AND KIT |
AXYA MEDICAL, INC. |
Howard Schrayer |
| K070077 |
01/08/2007 |
ULTRASOUND SCANNER PROFOCUS, MODEL 2202 |
B-K MEDICAL APS |
VILLY BRAENDER |
| K073205 |
11/13/2007 |
NIO 5MP, MODEL MDNG-5121 |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
NEIL PHILLIPS |
| K073184 |
11/13/2007 |
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS |
BAUSCH & LOMB, INC. |
DEBRA KETCHUM |
| K070163 |
01/17/2007 |
SWABBABLE CAP, MODEL 60205 |
BAXA CORP. |
KIMBERLY ZIZIK |
| K070125 |
01/16/2007 |
COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION |
BAXTER HEALTHCARE CORP. |
JEME WALLACE |
| K073326 |
11/27/2007 |
NRG TRANSSEPTAL NEEDLE |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K070130 |
01/16/2007 |
ORBITAL RECONSTRUCTIVE IMPLANT |
BECKER & ASSOCIATES CONSULTING INC |
CAMPBELL TUSKEY |
| K070144 |
01/16/2007 |
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
TYLER J FOUTCH |
| K070259 |
01/26/2007 |
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR |
BEDFONT SCIENTIFIC LTD. |
E.J. Smith |
| K073262 |
11/20/2007 |
BELLA |
BEEKLEY CORP. |
MARTINE M BOUTTE |
| K070293 |
01/31/2007 |
BENVENUE VCF OSTEO COIL SYSTEM |
BENVENUE MEDICAL, INC. |
LAURENT SCHALLER |
| K073299 |
11/23/2007 |
BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE |
BETELCARE SDN BHD |
KENG BENG SIAH |
| K073368 |
11/30/2007 |
5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT |
BICON, LLC |
VINCENT J MORGAN |
| K073360 |
11/30/2007 |
PROPLATE |
BIO PROTECH, INC. |
E.J. Smith |
| K070142 |
01/16/2007 |
SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 |
BIO-MEDICAL RESEARCH CORP. |
ANNE-MARIE KEENAN |
| K073307 |
11/23/2007 |
MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM |
BIO-TECHNOLOGY USA, INC. |
IAN GORDON |
| K073341 |
11/28/2007 |
GENEX PUTTY |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K070090 |
01/10/2007 |
RADIESSE LARYNGEAL IMPLANT |
BIOFORM MEDICAL, INC. |
JAMES MILLER |
| K073268 |
11/20/2007 |
BIOHORIZONS INTERNAL IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K073282 |
11/21/2007 |
BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K073146 |
11/08/2007 |
PADNET+ |
BIOMEDIX, INC. |
WILLIAM ROGERS |
| K073091 |
11/01/2007 |
VIDAS NT-PROBNP ASSAY, MODEL: 30 449 |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K073083 |
11/01/2007 |
VITEK 2 GRAM NEGATIVE PIPERACILLIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K070147 |
01/16/2007 |
INTERGRO ORAL |
BIOMET 3I |
TAMARA J NELSON |
| K073345 |
11/28/2007 |
CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT |
BIOMET 3I, INC. |
PRISCILLA CARO |
| K073102 |
11/02/2007 |
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K070015 |
01/03/2007 |
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT |
BIOMET MANUFACTURING CORP. |
GARY E BAKER, MS RAC |
| K070274 |
01/29/2007 |
ECHO BI-METRIC PRESS-FIT STEMS |
BIOMET MANUFACTURING CORP. |
SUSAN ALEXANDER |
| K070240 |
01/25/2007 |
CARTO XP EP NAVIGATION SYSTEM, VERSION 9 |
BIOSENSE WEBSTER, INC. |
NEELU MEDHEKAR |
| K073230 |
11/15/2007 |
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K073318 |
11/26/2007 |
BIPORE BALLOON DILATION CATHETER |
BIPORE, INC. |
KEITH PALUCH |
| K073263 |
11/20/2007 |
PRO-V |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
| K073316 |
11/26/2007 |
CERAMENT BONE VOID FILLER, MODEL A0210 |
BONESUPPORT AB |
ANN-CHRISTINE PROVOOST |
| K073266 |
11/20/2007 |
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
NEIL KELLY |
| K070002 |
01/03/2007 |
BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER |
BOSTONSCIENTIFIC |
NICHOLAS CONDAKES |
| K070106 |
01/11/2007 |
VV FLUORO 3D |
BRAINLAB AG |
RAINER BIRKENBACH |
| K073082 |
11/01/2007 |
CPS COURIER GUIDEWIRE |
BRIVANT, LTD. |
TOMAS FUREY |
| K070195 |
01/22/2007 |
BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B |
BROADSOUND CORPORATION |
JIANN HWA JENG, PHD |
| K073199 |
11/13/2007 |
3M ESPE LAVA CHAIRSIDE ORAL SCANNER |
BRONTES TECHNOLOGIES |
JOHN GREENBAUM |
| K073222 |
11/15/2007 |
MODIFICATION TO:SPECIALTY NEEDLES |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K070073 |
01/08/2007 |
ALIGN URETHRAL SUPPORT SYSTEM |
C.R. BARD, INC. |
JULIE J BASSETT |
| K070201 |
01/22/2007 |
BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 |
C.R. BARD, INC. |
MICHELLE GUDITH |
| K073090 |
11/01/2007 |
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J |
C.R. BARD, INC. |
GENEVIEVE BALUTOWSKI |
| K070025 |
01/03/2007 |
C.T.M. MOBILITY SCOOTER, MODEL HS-310 |
C.T.M. HOMECARE PRODUCT, INC. |
LINDA J BOVARD |
| K073226 |
11/15/2007 |
CINCH KNOTLESS FIXATION IMPLANT SYSTEM |
C2M MEDICAL, INC. |
GABRIELE G NIEDERAUER |
| K070235 |
01/25/2007 |
BODYGUARD PAIN MANAGER INFUSION SYSTEM |
CAESAREA MEDICAL ELECTRONICS LTD. |
SHLOMI DINES |
| K070220 |
01/23/2007 |
OSTEOFIX BONE VOID FILLER |
CALCITEC, INC |
JANICE M HOGAN |
| K070070 |
01/08/2007 |
ASCENT DENTAL CLEANSER |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K073123 |
11/06/2007 |
CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 |
CARDICA, INC. |
ISKRA MRAKOVIC |
| K073304 |
11/23/2007 |
CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES |
CARDICA, INC. |
ISKRA MRAKOVIC |
| K070268 |
01/29/2007 |
SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X |
CARDINAL HEALTH 303, INC. |
STACY L LEWIS |
| K070091 |
01/10/2007 |
COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208 |
CARDINAL HEALTH, INC. |
SHARON NICHOLS |
| K070156 |
01/17/2007 |
BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 |
CARDIODYNAMICS INTERNATIONAL CORP. |
PAUL L SHAFFER |
| K073194 |
11/13/2007 |
CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS |
CARDIOVASCULAR IMAGING SOLUTIONS LTD. |
CARL THOMAS |
| K073207 |
11/13/2007 |
OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 |
CELON AG MEDICAL INSTRUMENTS |
LAURA STORMS-TYLER |
| DEN070001 |
01/16/2007 |
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
HYE-JOO KIM |
| K070093 |
01/10/2007 |
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE |
CEREMED INC. |
TADEUSZ WELLISZ M.D. |
| K073213 |
11/14/2007 |
THERABOND ANTIMICROBIAL BARRIER SYSTEMS |
CHOICE THERAPEUTICS |
HOWARD M HOLSTEIN |
| K073334 |
11/28/2007 |
OHMNISCAN NG |
CHRISTINE VALMY INC |
PETER DEHAYDU |
| K070054 |
01/04/2007 |
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST |
CHURCH & DWIGHT CO., INC. |
CYNTHIA DAVIDSON |
| K073180 |
11/13/2007 |
SMARTSPONGE PLUS SYSTEM |
CLEARCOUNT MEDICAL SOLUTIONS, INC. |
JEFF WOLFGONG |
| K073336 |
11/28/2007 |
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 |
Codman & Shurtleff, Inc. |
EMILY E VALERIO |
| K070269 |
01/29/2007 |
MODIFICATION TO COLLAWOUND DRESSING |
COLLAMATRIX CO., INC. |
DENNIS J SEAH |
| K073124 |
11/06/2007 |
COLLIMARE COLLIMATOR FAMILY |
COLLIMARE, LLC |
HOWARD C THOMAS |
| K070233 |
01/25/2007 |
CONMED LINVATEC SMART GUARD IRRIGATOR |
CONMED LINVATEC |
ELIZABETH M PAUL |
| K070279 |
01/29/2007 |
MODIFICATION TO HYPERTRANSIT INFUSION CATHETER |
CORDIS NEUROVASCULAR, INC. |
ROBERTO F REFECA |
| K073122 |
11/06/2007 |
MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE |
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
DEBORA STAPLETON |
| K073164 |
11/09/2007 |
IVS TUNNELLER DEVICES |
COVIDIEN UK MANUFACTURING LTD |
SHARON ALEXANDER |
| K070281 |
01/29/2007 |
ISSYS LP SPINAL FIXATION SYSTEM |
CUSTOM SPINE, INC. |
RICHARD JANSEN |
| K070138 |
01/16/2007 |
CUTERA ER:YAG LASER HANDPIECE |
CUTERA, INC. |
Connie Hoy |
| K070272 |
01/29/2007 |
NEUROPORT ELECTRODE |
CYBERKINETICS NEUROTECHNOLOGY SYSTEMS, INC. |
Gary Syring |
| K070063 |
01/05/2007 |
YAG MIR II LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K070124 |
01/16/2007 |
GASTROSTOMY REPLACEMENT TUBE, MODEL 253 |
DEGANIA SILICONE, LTD. |
ZOYA LEE |
| K073242 |
11/19/2007 |
PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 |
DELPHI MEDICAL SYSTEMS |
GILBERT ROQUE |
| K070297 |
01/31/2007 |
CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT |
DENTAL AIR SOLUTIONS OF NC, INC. |
THOMAS FEE |
| K070191 |
01/22/2007 |
ALPHA-CORE DC |
DENTAL TECHNOLOGIES, INC. |
JANINE RAUHUT |
| K070228 |
01/24/2007 |
IMPLANTIUM PROSTHETICS |
DENTIUM CO., LTD. |
CATHRYN N CAMBRIA |
| K073218 |
11/15/2007 |
MTA ADVANCED MATERIAL |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K073173 |
11/13/2007 |
SELF-ADHESIVE RESIN CEMENT |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K070019 |
01/03/2007 |
CARRARA VOLUMIA |
DENTSPLY INTL. |
HELEN LEWIS |
| K073117 |
11/05/2007 |
DENTIN DESENSITIZER AGENT |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K073281 |
11/21/2007 |
CAIS STAPLE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
RUTH C FORSTADT |
| K070267 |
01/29/2007 |
DEPUY GCK TIBIAL COMPONENTS |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K073364 |
11/30/2007 |
EXPEDIUM 4.5MM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K070300 |
01/31/2007 |
EXPEDIUM SFX CROSS CONNECTOR SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K073126 |
11/06/2007 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K073260 |
11/20/2007 |
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 |
DEVICE PARTNERS INTERNATIONAL |
MONICA E DOUGHERTY |
| K073118 |
11/05/2007 |
PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM |
DIAGNOSTIC DEVICES INC. |
ERICA LI |
| K070206 |
01/22/2007 |
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 |
DIAGNOSTIC HYBRIDS, INC. |
GAIL GOODRUM |
| K070265 |
01/29/2007 |
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 |
DIAGNOSTIC HYBRIDS, INC. |
GAIL GOODRUM |
| K070104 |
01/10/2007 |
PROLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC. |
RANDOLPH QUINN |
| K070062 |
01/05/2007 |
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE |
DIESSE DIAGNOSTICA SENESE S.P.A |
RAUL ALVAREZ |
| K073163 |
11/09/2007 |
LIMITED ARTIFACT SKULL PIN, MODEL 0107 |
DINKLER SURGICAL DEVICES, INC. |
CHARLES E DINKLER II |
| K070189 |
01/22/2007 |
ACCU-CHEK ULTRAFLEX INFUSION SET |
DISETRONIC MEDICAL SYSTEMS AG |
MIKE FLIS |
| K070117 |
01/12/2007 |
SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC |
DOLOMITE BIOTECH SDN BHD |
TIMOTHY LIEW |
| K070123 |
01/16/2007 |
TCA 5R / 5S |
DORNIER MEDTECH AMERICA, INC. |
Tim Thomas |
| K073113 |
11/05/2007 |
INFINITY PICCO POD, MODEL MS16734 |
Draeger Medical Systems, Inc. |
GENCI OMARI |
| K073331 |
11/27/2007 |
DVO EXTENDED ARTICULATION HUMERAL HEADS |
DVO EXTREMITY SOLUTIONS, LLC |
JEFF ONDRLA |
| K073116 |
11/05/2007 |
EBI INTERNAL IMPLANT SYSTEM |
EBI, INC. |
DANIEL KAMM |
| K073221 |
11/15/2007 |
CADENCE II |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K073340 |
11/28/2007 |
COLOR LCD MONITOR, FLEXSCAN MX300W |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K070122 |
01/16/2007 |
MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K070131 |
01/16/2007 |
RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K073166 |
11/09/2007 |
ENDOWAVE INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K070221 |
01/24/2007 |
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K070050 |
01/04/2007 |
VITALITY HIP SYSTEM MODEL#420 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K073267 |
11/20/2007 |
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
ENDIUS, INC. |
REGINA WAGNER |
| K070282 |
01/29/2007 |
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
ENDIUS, INC. |
REGINA WAGNER |
| K070246 |
01/25/2007 |
DOWN PAK |
ENDO TWINN B.V. |
F.M. VERHOEVEN |
| K070193 |
01/22/2007 |
ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES |
ENVITEC-WISMAR GMBH |
STEPHEN GORSKI |
| K073096 |
11/01/2007 |
ANCHORAGE CLOSURE DEVICE |
EPITEK, INC. |
WERNER HAMPL |
| K070053 |
01/04/2007 |
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K070084 |
01/09/2007 |
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL |
EST. ANTHOGYR |
ERIC GENEVE |
| K073288 |
11/21/2007 |
ETHICON ENDO SURGERY ARTICULATING SNARE |
ETHICON ENDO-SURGERY, INC. |
GLENDA C MARSH |
| K070198 |
01/22/2007 |
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 |
ETHICON ENDO-SURGERY, LLC |
WENDY TURNER |
| K070151 |
01/16/2007 |
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER |
ETHICON ENDO-SURGERY, LLC |
KIMBERLY SHOEMAKER |
| K070224 |
01/24/2007 |
ULTRAPRO PLUG |
ETHICON, INC. |
BRYAN A LISA |
| K070239 |
01/25/2007 |
MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM |
EXIR PHARMACEUTICAL CO. |
ERICA LI |
| K070299 |
01/31/2007 |
EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) |
EZFIT TECHNOLOGY INC. |
OU YANG |
| K073317 |
11/26/2007 |
STARLIGHT, MODEL PD9012 |
F.P. RUBINSTEIN Y CIA S.R.L. |
HAYDEE N DEMARCO |
| K070209 |
01/22/2007 |
FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR |
FEGO PRECISION INDUSTRIAL CO; LTD |
JENNIFER REICH |
| K073339 |
11/28/2007 |
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR |
FENWAL, INC. |
TAMMY DAVIS |
| K070135 |
01/16/2007 |
VITRIFREEZE MEDIUM; VITRITHAW MEDIUM |
FERTI PRO N.V. |
GRACE HOLLAND |
| K073251 |
11/19/2007 |
HYALOMATRIX PA |
FIDIA ADVANCED BIOPOLYMERS SRL |
SHARON A SEGAL |
| K073289 |
11/21/2007 |
MICROSHEATH XL CATHETERS |
FLOWCARDIA, INC. |
Dustin Michaels |
| K073330 |
11/27/2007 |
FREEDOM SCIENCES MOTION CONTROL MODULE (MCM) |
FREEDOM SCIENCES, LLC |
EDWARD A KROLL |
| K070049 |
01/04/2007 |
FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET C KAY |
| K070177 |
01/18/2007 |
FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET C KAY |
| K070222 |
01/24/2007 |
FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET C KAY |
| K070190 |
01/22/2007 |
GRADIA DIRECT X |
GC AMERICA INC. |
TERRY L JORITZ-LYONS |
| K073283 |
11/21/2007 |
GC GAM-100 |
GC AMERICA, INC. |
MARK HEISS |
| K073106 |
11/02/2007 |
UNIFAST III |
GC AMERICA, INC. |
MARK HEISS |
| K073138 |
11/07/2007 |
CARDIQ EXPRESS VERSION 2.0 |
GE MEDICAL SYSTEMS |
STEPHEN SLAVENS |
| K073203 |
11/13/2007 |
CARESCAPE V100 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KAREN RUSSELL |
| K073153 |
11/08/2007 |
CARDIQ FUNCTION XPRESS |
GE MEDICAL SYSTEMS SCS |
|
| K073167 |
11/09/2007 |
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER |
GE MEDICAL SYSTEMS, LLC |
|
| K073297 |
11/23/2007 |
GE LOGIQ P6 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K070018 |
01/03/2007 |
UNIVERSAL SURGICAL MESH, MODEL 100 |
GENERIC MEDICAL DEVICE, INC. |
MONICA R MONTANEZ |
| K070280 |
01/29/2007 |
CARDIODAY, VERSION 2.0 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
ROMIL RAMBHIA |
| K073154 |
11/08/2007 |
FACTS HAND AND PINCH GRIP COMBO |
GLOBAL SERVICES GROUP, LLC |
RAY GAGNE |
| K073172 |
11/13/2007 |
BEACON STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K073246 |
11/19/2007 |
ZENIEVA |
GORBEC PHARMACEUTICAL SERVICES, INC. |
SANDRA R KIRCUS |
| K070096 |
01/10/2007 |
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR |
GX CORPORATION SDN BHD |
FOO KHON PU |
| K070097 |
01/10/2007 |
POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR |
GX CORPORATION SDN BHD |
FOO K PU |
| K073182 |
11/13/2007 |
GYN DISPOSABLES TENACULUM 356T |
GYN-DISPOSABLES, INC. |
JAMES K PATTERSON |
| K073225 |
11/15/2007 |
SENSEI CATHETER CONTROL SYSTEM |
HANSEN MEDICAL, INC. |
DOUG WORTH |
| K070100 |
01/10/2007 |
HASELMEIER PEN |
HASELMEIER SARL |
MELISSA MAHALL |
| K073237 |
11/16/2007 |
REHASTIM & REHAMOVE |
HASOMED GMBH |
MATTHIAS WEBER |
| K070061 |
01/05/2007 |
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT |
HAYES MEDICAL, INC. |
LUKE ROSE |
| K073314 |
11/26/2007 |
HEANY INDUSTRIES INC DENTAL XIRCONIA |
HEANY INDUSTRIES INC |
COREY DUNN |
| K073358 |
11/29/2007 |
LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A |
HEEYOUNG CO., LTD. |
CARL THOMAS |
| K073292 |
11/23/2007 |
MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM |
HEEYOUNG CO., LTD. |
CARL THOMAS |
| K070211 |
01/22/2007 |
TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM |
HEMOSTASIS, LLC |
KEITH ROBERTS |
| K073310 |
11/23/2007 |
OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL |
HITACHI MEDICAL CORP. |
DOUG THISTLEWAITE |
| K043617 |
11/26/2007 |
IMAGECHECKER CT CAD SOFTWARE SYSTEM |
HOLOGIC, INC. |
ARTHUR FRIEDMAN |
| K070187 |
01/22/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
HONG DI PLASTIC PRODUCTS CO, LTD. |
KATHY LIU |
| K070188 |
01/22/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW |
HONG DI PLASTIC PRODUCTS CO, LTD. |
KATHY LIU |
| K070249 |
01/26/2007 |
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H |
HORIBA ABX |
PASCAL MACZIOLA |
| K070146 |
01/16/2007 |
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP |
HORIBA ABX |
PASCAL MACZIOLA |
| K073309 |
11/23/2007 |
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT |
HORIBA ABX |
OLIVIER DUCAMP |
| K070095 |
01/10/2007 |
TRIATHLON TS KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
| K073158 |
11/08/2007 |
SCULPTURE 2.94 ER:YAG SYSTEM |
HOYA CONBIO, INC |
LIZA BURNS |
| K073332 |
11/27/2007 |
V-RASER DIODE LASER SYSTEM |
HOYA CONBIO, INC |
LIZA BURNS |
| K070196 |
01/22/2007 |
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT |
HR DENTAL PRODUCTS INC |
JIM RONALDS |
| K073369 |
11/30/2007 |
EI DOWNPAK BARRIER SLEEVES |
HU-FRIEDY MFG. CO., INC |
KEITH DUNN |
| K073190 |
11/13/2007 |
SLIT LAMP |
HUVITZ CO., LTD. |
CHARLIE MACK |
| K073269 |
11/21/2007 |
HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM |
HYPNOCORE, LTD. |
GEORGE J HATTUB |
| K070079 |
01/09/2007 |
X3C DIGITAL RADIOGRAPHIC DETECTOR |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHAN SAMARAPPULI |
| K073114 |
11/05/2007 |
IMIX INSIGHT X-RAY SYSTEMS |
IMIX ADR FINLAND OY |
DANIEL KAMM |
| K073161 |
11/09/2007 |
REPLUS DENTAL IMPLANTS (HA) |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K073217 |
11/15/2007 |
INCLUSIVE IMPLANT ABUTMENTS |
INCLUSIVE DENTAL SOLUTIONS |
KEITH D ALLRED |
| K073145 |
11/08/2007 |
QUANTA LITE H-TTG SCREEN |
INOVA DIAGNOSTICS, INC. |
JOSEPH PHILLIPS |
| K070083 |
01/09/2007 |
QUANTA LITE H-TTG/DGP SCREEN |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K070066 |
01/08/2007 |
QUANTA LITE RNA POL III ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K070136 |
01/16/2007 |
AUDICOR 200 SYSTEM, MODELS 200D AND 200S |
INOVISE MEDICAL, INC. |
STEVE HESLER |
| K070301 |
01/31/2007 |
HEMOSIL ANTITHROMBIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K073367 |
11/30/2007 |
HEMOSIL FIBRINOGEN-C |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K070005 |
01/03/2007 |
HEMOSIL RECOMBIPLASTIN 2G |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K070080 |
01/09/2007 |
INTELEPACS |
INTELERAD MEDICAL SYSTEMS INC. |
ANIBAL JODORCOVSKY |
| K073105 |
11/02/2007 |
PEEK SPINAL SPHERES |
INTERBODY INNOVATIONS, LLP |
J.D. WEBB |
| K073112 |
11/05/2007 |
DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K073134 |
11/07/2007 |
A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I |
INVACARE CORPORATION |
CARROLL MARTIN |
| K070203 |
01/22/2007 |
INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024 |
INVIRO MEDICAL DEVICES, INC. |
JIM BARLEY |
| K070011 |
01/03/2007 |
IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER |
IRVINE BIOMEDICAL,INC.(IBI) |
ROHIT PATEL |
| K070250 |
01/26/2007 |
NUTRITONE FACIAL BEAUTY SYSTEM |
ISOMERS LABORATORIES INC. |
ROBERT MAZZAFERRO |
| K070074 |
01/08/2007 |
LUBRINA, MODEL HIM-1 |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K070114 |
01/12/2007 |
CREATION CP-ZI PORCELAIN |
JENSEN INDUSTRIES, INC. |
GARY PHELPS |
| K070021 |
01/03/2007 |
ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 |
JG MEDICAL PRODUCTS LLC |
WILLAIM STERN |
| K070076 |
01/08/2007 |
POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED) |
JIANGSU CUREGUARD GLOVE CO., LTD. |
CHU XIAOAN |
| K070075 |
01/08/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
JIANGSU CUREGUARD GLOVE CO., LTD. |
CHU XIAOAN |
| K070143 |
01/16/2007 |
JMS PLANECTA STOPCOCK |
JMS NORTH AMERICA CORP. |
CHONG SWEE CHEAU |
| K070234 |
01/16/2007 |
JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS |
JMS NORTH AMERICA CORP. |
SWEE CHEAU CHONG |
| K070229 |
01/24/2007 |
RANGE SPINAL SYSTEM |
K2M, INC. |
RICHARD W WOODS |
| K073214 |
11/14/2007 |
DUOWEDGE SYNTHETIC BONE SUBSTITUTE |
KASIOS |
J.D. WEBB |
| K073257 |
11/19/2007 |
KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR |
KAWASUMI LABORATORIES, INC. |
JACK PAVLO |
| K073162 |
11/09/2007 |
SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING |
KENSEY NASH CORPORATION |
ROBIN FATZINGER |
| K073209 |
11/14/2007 |
MAXCEM 2 |
KERR CORPORATION |
COLLEEN BOSWELL |
| K070127 |
01/16/2007 |
PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 |
KEVIN VU, DDS |
Glen Feye |
| K070270 |
01/29/2007 |
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 |
KIRCHNER & WILHELM GMBH + CO.KG |
NATALYA VALERIO |
| K070169 |
01/18/2007 |
KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE |
KLS MARTIN L.P. |
JENNIFER DAMATO |
| K070183 |
01/19/2007 |
KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K070012 |
01/03/2007 |
POLYBONE |
KYUNGWON MEDICAL CO., LTD. |
JOO YEON LEE |
| K073144 |
11/07/2007 |
LANX INTERVERTEBRAL BODY FUSION DEVICE |
LANX, LLC |
GREG CAUSEY |
| K073104 |
11/02/2007 |
SKINTACT AND VARIOUS OTHER TRADENAMES |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K070285 |
01/29/2007 |
LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K073274 |
11/21/2007 |
SPINAL SPHERE SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K073187 |
11/13/2007 |
PERIPHERAL NERVE BLOCK SUPPORT TRAY |
LIFE-TECH, INC. |
JEFF KASOFF |
| K073231 |
11/15/2007 |
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
KIM FONDA |
| K070022 |
01/03/2007 |
MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 |
M.I.S. IMPLANTS TECHNOLOGIES LTD. |
MOTTI WEISMAN |
| K073248 |
11/19/2007 |
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K073179 |
11/13/2007 |
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 |
MAQUET CRITICAL CARE AB |
JAMIE YIEH |
| K070048 |
01/03/2007 |
GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT |
MARIAN MEDICAL, INC. |
SANDRA WINKLER |
| K070176 |
01/18/2007 |
MAXHEALTH MECHANICAL WHEELCHAIR, K1 |
MAXHEALTH CORP. |
JEN KE-MIN |
| K073337 |
11/28/2007 |
MECTACER BIOLOX FORTE-FEMORAL HEADS |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K070003 |
01/03/2007 |
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) |
MEDCOMP |
JEAN CALLOW |
| K070112 |
01/11/2007 |
RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM |
MEDCOOL INC |
MAUREEN O'CONNELL |
| K070129 |
01/16/2007 |
SONOTIP II ULTRASOUND NEEDLE SYSTEM |
MEDI-GLOBE CORPORATION |
SCOTT KARLER |
| K070057 |
01/05/2007 |
EASYRA CLINICAL CHEMISTRY ANALYZER |
MEDICA CORP. |
Photios Makris |
| K070085 |
01/09/2007 |
BALANCE REHABILITATION UNIT (BRU) |
MEDICAA (URUGUAY) S.A. |
IAN GORDON |
| K073323 |
11/27/2007 |
SA-3000P |
MEDICORE CO., LTD. |
YOO BYUNG-KUK |
| K070276 |
01/29/2007 |
MODIFICATION TO PASSMED SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J. D WEBB |
| K073156 |
11/08/2007 |
QPLAQUE MR |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
| K070291 |
01/30/2007 |
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX |
MEDIX I.C.S.A. |
JAMES H KNAUSS |
| K070072 |
01/08/2007 |
NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES |
MEDTEXX MANUFACTURING SDN. BHD. |
OOI LOON SENG (MDM) |
| K070175 |
01/18/2007 |
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K070286 |
01/29/2007 |
BIO-CONSOLE, MODEL 560 |
Medtronic |
CHERYL NORTON |
| K073324 |
11/27/2007 |
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R |
MEDTRONIC INC. |
BECKY HANNACK |
| K073356 |
11/29/2007 |
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 |
MEDTRONIC MINIMED |
MARK J FAILLACE |
| K073139 |
11/07/2007 |
SMALL LUMEN PERITONEAL CATHETER |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K073291 |
11/23/2007 |
CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LEE GRANT |
| K073285 |
11/23/2007 |
PEEK PREVAIL CERVICAL INTERBODY DEVICE |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MICHAEL SCOTT |
| K070173 |
01/18/2007 |
VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
CHRISTINE SCIFERT |
| K070288 |
01/30/2007 |
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 |
MEDTRONIC VASCULAR |
SCOTT CUNDY |
| K073255 |
11/19/2007 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
DAVID GUZEK |
| K070039 |
01/03/2007 |
MEMOMETAL FIXOS SCREWS |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
| K070031 |
01/03/2007 |
MEMOMETAL MEMORY STAPLES |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
| K070033 |
01/03/2007 |
MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10 |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
| K070254 |
01/26/2007 |
HORIZON SE |
MENNEN MEDICAL LTD. |
MICHA OESTEREICH |
| K073140 |
11/07/2007 |
VITALOGIK MODEL 4000/4500 |
MENNEN MEDICAL LTD. |
IFAT OREN |
| K070016 |
01/03/2007 |
BLUE SHARK |
MERIDAN MEDICAL |
GRACE HOLLAND |
| K070159 |
01/17/2007 |
PRELUDE SHEATH INTRODUCER |
MERIT MEDICAL SYSTEMS, INC. |
JERRIE HENDRICKSON |
| K073110 |
11/05/2007 |
MERITS E600 SERIES STAIR LIFT |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K073198 |
11/13/2007 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1) |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K073131 |
11/06/2007 |
MICROMRI WRIST COIL |
MICROMRI, INC. |
Hrishikesh Gadagkar |
| K070023 |
01/03/2007 |
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 |
MICROSURGEON, INC. |
DUDLEY HARRIS |
| K073300 |
11/23/2007 |
MILESMAN PREMIUM |
MILESMAN S.L. |
NATALYA VALERIO |
| K073176 |
11/13/2007 |
KANTERON DICOM STATION (KDS), MODEL 3.0 |
MONICA VEYTIA |
MONICA VEYTIA |
| K070001 |
01/03/2007 |
MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE |
MTI PRECISION PRODUCTS |
TOD BRENNER |
| K073329 |
11/27/2007 |
SYGNAL DBM |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ |
| K073236 |
11/16/2007 |
NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE |
NEOCOIL |
BRIAN BROWN |
| K073181 |
11/13/2007 |
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL |
NEOCOIL, LLC |
BRIAN BROWN |
| K070150 |
01/16/2007 |
VASCUPUNCTURE PICC GUIDEWIRE |
NEOMETRICS, INC. |
GENE CHAMPEAU |
| K070217 |
01/23/2007 |
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE |
NEURO RESOURCE GROUP, INC. |
KRISTA OAKES |
| K070109 |
01/11/2007 |
NEUROMETRIX ADVANCE |
NEUROMETRIX, INC. |
RAINER N MAAS |
| K070241 |
01/25/2007 |
MODIFICATION TO LAPIDUS PLATE |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K070160 |
01/17/2007 |
MODIFICATION TO TTC PLATES |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K070231 |
01/24/2007 |
ORION |
NIDEK TECHNOLOGIES SRL |
ALDO COCCHIGLIA |
| K070182 |
01/19/2007 |
ZYGOMA IMPLANT (IMMEDIATE FUNCTION) |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K073142 |
11/07/2007 |
NOBELREPLACE HEXAGONAL IMPLANT |
NOBEL BIOCARE USA LLC |
KAM LEUNG |
| K073099 |
11/02/2007 |
FMRI HARDWARE SYSTEM |
NORDICNEUROLAB |
CONSTANCE G BUNDY |
| K073132 |
11/07/2007 |
MODEL D DISC FORCE |
NORTH AMERICAN MEDICAL CORP (NAM) |
CHELLO GRACE |
| K070014 |
01/03/2007 |
AUTO DETECT FOR TELAHEART DR200/E-A |
NORTHEAST MONITORING, INC. |
JOSEPH AZARY |
| K070255 |
01/26/2007 |
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD, PHD |
| K070068 |
01/08/2007 |
NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD,PHD |
| K073088 |
11/01/2007 |
SPY FLUORESCENT IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K073130 |
11/06/2007 |
SPY FLUORESCENT IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K073121 |
11/05/2007 |
NUBRACE INVISIBLE REMOVABLE ORTHODONTICS |
NUBRACE, INC. |
JONATHAN S KAHAN |
| K073273 |
11/21/2007 |
EQUAL DOSE 1.0 |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K073107 |
11/02/2007 |
VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 |
NUCLETRON CORPORATION |
LISA] DIMMICK |
| K070047 |
01/04/2007 |
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH |
NUNC A/S |
JANA S HELLMANN |
| K070148 |
01/16/2007 |
GRAFT CONTAINMENT DEVICE |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K070273 |
01/29/2007 |
MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K073275 |
11/21/2007 |
NUVASIVE HELIX MINI ACP SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K073278 |
11/21/2007 |
SPINOUS PROCESS PLATE SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K073293 |
11/23/2007 |
DURETTE IMPLANT |
OCULO PLASTIK, INC. |
JEAN-FRANCOIS DURETTE |
| K070210 |
01/22/2007 |
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM |
OHMEDA MEDICAL |
AGATA SMIEJA |
| K070247 |
01/25/2007 |
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM |
OHMEDA MEDICAL |
AGATA SMIEJA |
| K073150 |
11/08/2007 |
APEX-LNK POLY ACETABULAR CUP LINERS |
OMNI LIFE SCIENCE, INC. |
EDWARD J CHEAL |
| K073313 |
11/26/2007 |
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K070157 |
01/17/2007 |
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K070071 |
01/08/2007 |
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K073157 |
11/08/2007 |
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE HANNA |
| K070132 |
01/16/2007 |
TRIPORE, MODELS HA, BP90, BP15 |
ORTHOGEM LIMITED |
ROD RUSTON |
| K073344 |
11/28/2007 |
ORTHOPEDIATRICS PLATING SYSTEM |
ORTHOPEDIATRICS, LLC |
GARY BARNETT |
| K073228 |
11/15/2007 |
DC ULNAR SHORTENING SYSTEM |
ORTHOPRO LLC |
J.D. WEBB |
| K073100 |
11/02/2007 |
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S |
Oscor Inc. |
MILA DOSKOCIL |
| K070184 |
01/19/2007 |
DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT |
OSPOL AB |
LENNART CARLSSON |
| K070155 |
01/17/2007 |
INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC |
OSSEO SCIENTIFIC, LLC |
MICHAEL FELDMAN |
| K073247 |
11/19/2007 |
US/SS/GS SYSTEM |
OSSTEM IMPLANT CO LTD |
MINJOO KIM |
| K070212 |
01/22/2007 |
CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM) |
OVALUM LTD. |
KEN RAICHMAN |
| K070262 |
01/26/2007 |
ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K073328 |
11/27/2007 |
CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA |
PAIEON, INC. |
RAVIT BARKAMA |
| K070179 |
01/19/2007 |
TROKABONE, TROKABONE STERNAL |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K073363 |
11/30/2007 |
THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 |
PALADIN BIOMEDICAL CORPORATION |
ROBERT BICKFORD |
| K070298 |
01/31/2007 |
MODIFICATION TO PALOMAR LUXIR HANDPIECE |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
| K073362 |
11/30/2007 |
MROPEN |
PARAMED SRL |
MICHAEL A DOUGLAS |
| K070107 |
01/11/2007 |
PARI HYDRATE G |
PARI INNOVATIVE MANUFACTURERS, INC. |
MICHAEL JUDGE |
| K073210 |
11/14/2007 |
MODIFICATION TO: T-PORT HP INFUSION PORT |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K070009 |
01/03/2007 |
AT HOME DRUG TEST MODELS, 9308T AND 9308X |
PHAMATECH INC. |
CARL MONGIOVI |
| K070098 |
01/10/2007 |
QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC |
PHAMATECH INC. |
CARL MONGIOVI |
| K070185 |
01/19/2007 |
TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 |
PHAROS LIFE CORPORATION |
PHIL CUSCUNA |
| K070260 |
01/26/2007 |
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0 |
PHILIPS MEDICAL SYSTEMS |
DENISE HALEY |
| K070287 |
01/29/2007 |
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 |
PHOTONIC OPTISCHE GERATE GMBH & COKG |
DIETER FEGER |
| K073089 |
11/01/2007 |
LIFEPAK 20E |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K073229 |
11/15/2007 |
NERVE MONITORING CABLE |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K073177 |
11/13/2007 |
PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K070020 |
01/03/2007 |
COMCASET-P SAFETY IV CATHETER |
PITANGO MEDICAL LTD |
BEN LEVIN |
| K070278 |
01/29/2007 |
POLARCUP DUAL MOBILITY SYSTEM |
PLUS ORTHOPEDICS AG |
PAMELA J WEAGRAFF |
| K070251 |
01/26/2007 |
CARBON DIOXIDE LIQUID STABLE REAGENT |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS, JR |
| K070207 |
01/22/2007 |
MULTI-ANALYTE CHEMISTRY CALIBRATOR |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
| K070017 |
01/03/2007 |
PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K073148 |
11/08/2007 |
IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K073220 |
11/15/2007 |
THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT |
PRESTIGE BRANDS, INC. |
KAREN A COSTA-STRACHAN |
| K073224 |
11/15/2007 |
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH |
PROCTER & GAMBLE |
MICHAEL A KAMINSKI |
| K073353 |
11/29/2007 |
DO-ALL DENTAL HANDPIECE LUBRICANT |
PRODRIVE SYSTEMS, INC. |
TIMOTHY F NASON |
| K073178 |
11/13/2007 |
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 |
R & D SYSTEMS, INC. |
NANCY C RING |
| K070213 |
01/22/2007 |
PERFORMER CBP SYSTEM |
RAND S.R.L. |
PREETI JAIN |
| K073349 |
11/29/2007 |
RELIANCE BUTTRESS WASHER SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K073243 |
11/19/2007 |
LED PRO SEAL |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PAUL GANGE |
| K070284 |
01/29/2007 |
FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) |
RELIANT TECHNOLOGIES, INC. |
HEATHER MACFALLS |
| K070263 |
01/26/2007 |
APNEALINK |
RESMED GERMANY INC. |
DAVID D'CRUZ |
| K070180 |
01/19/2007 |
WALLABY 4 |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K073111 |
11/05/2007 |
PORTRAIT PSR, MODEL 745915 |
RHYTEC INCORPORATED |
Robert Zoletti |
| K070101 |
01/10/2007 |
UNIBLATE ELECTROSURGICAL DEVICE |
RITA MEDICAL SYSTEMS, INC. |
KAM H LEUNG |
| K073277 |
11/21/2007 |
ROCHE-CREACTIVE PROTEIN (LATEX) |
ROCHE DIAGNOSTICS CORP. |
KERWIN L KAUFMAN |
| K070200 |
01/22/2007 |
TDM CONTROL SET, MODEL CAT# 04521536 |
ROCHE DIAGNOSTICS CORP. |
DIMITRIS DEMIRTZOGLOU |
| K070174 |
01/18/2007 |
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY |
ROCHE DIAGNOSTICS CORPORATION |
THERESA AMBROSE BUSH |
| K070172 |
01/18/2007 |
AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
ROCHE DIAGNOSTICS CORPORATION |
THERESA AMBROSE BUSH |
| K070275 |
01/29/2007 |
FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE |
RUBICOR MEDICAL, INC. |
HUGH MAGEN |
| K073342 |
11/28/2007 |
SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW |
SALVIN DENTAL SPECIALTIES, INC. |
ROBERT SALVIN |
| K073206 |
11/13/2007 |
NEEDLE-TRAP/NEEDLE SAFETY LABEL |
SCHREINER MEDIPHARM |
Lee Leichter |
| K073319 |
11/26/2007 |
STATMATIC 31 HANDPIECE MAINTENANCE UNIT |
SCICAN LTD. |
BRENDA MURPHY |
| K073169 |
11/09/2007 |
SCIMAGE PICOMENTERPRISE |
SCIMAGE, INC. |
GARY J ALLSEBROOK |
| K070086 |
01/09/2007 |
SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR |
SENSACARE LTD. |
STEVEN CHANG |
| K070244 |
01/25/2007 |
AEGIS |
SENTINELLE MEDICAL, INC. |
STEPHEN LEUNG |
| K070126 |
01/16/2007 |
OCCLUSION BALLOON CATHETER |
SENTREHEART INC. |
LINDA GUTHRIE |
| K073127 |
11/06/2007 |
BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
Diana Hong |
| K073152 |
11/08/2007 |
PC-180 / PRINCE 180 EASY ECG MONITOR |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
|
| K073366 |
11/30/2007 |
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041 |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
CHARLES MACK |
| K073280 |
11/21/2007 |
BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K070044 |
01/03/2007 |
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION |
SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L |
KATHY LIU |
| K070037 |
01/03/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L |
KATHY LIU |
| K070046 |
01/03/2007 |
POWDERED VINYL PATIENT GLOVE |
SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L |
KATHY LIU |
| K070027 |
01/03/2007 |
POWDERED (WHITE) VINYL PATIENT EXAMINATION |
SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L |
KATHY LIU |
| K070026 |
01/03/2007 |
POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L |
KATHY LIU |
| K070041 |
01/03/2007 |
POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L |
KATHY LIU |
| K073193 |
11/13/2007 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD |
CHU XIAOAN |
| K073192 |
11/13/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD |
CHU XIAOAN |
| K070226 |
01/24/2007 |
CARDIOCT |
SHINA SYSTEMS LTD. |
ELI M ORBACH |
| K073238 |
11/16/2007 |
SYNGO VOLUME PERFUSION-CT NEURO |
SIEMENS AG, MEDICAL SOLUTIONS |
RALF HOFMANN |
| K073290 |
11/21/2007 |
ARTIS ZEE AND ZEEGO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY JOHNSON |
| K070181 |
01/19/2007 |
SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX |
SINTEA BIOTECH, INC. |
GUSTAVO A RIOS |
| K070236 |
01/25/2007 |
SBI LATERAL RADIO CAPITELLUM |
SMALL BONE INNOVATIONS, INC. |
ROBERT HOEHN |
| K070167 |
01/18/2007 |
ENDOBUTTON DIRECT |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
DEANA BOUSHELL |
| K070266 |
01/29/2007 |
560 HIGH DEFINITION CAMERA SYSTEM |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K073175 |
11/13/2007 |
JOURNEY UNICONDYLAR FEMORAL IMPLANT |
SMITH & NEPHEW, INC. |
MARLON RIDLEY |
| K073325 |
11/27/2007 |
LEGION POROUS PRIMARY |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K073188 |
11/13/2007 |
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
| K070116 |
01/12/2007 |
POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE |
SMITHS MEDICAL MD, INC. |
PHIL NEURURER |
| K073287 |
11/21/2007 |
PREVADH MESH |
SOFRADIM PRODUCTION |
SHARON ALEXANDER |
| K073249 |
11/19/2007 |
SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES |
SOLARIS MEDICAL TECHNOLOGY, INC. |
ALAN SCHWARTZ |
| K073095 |
11/01/2007 |
TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 |
SOMATEX MEDICAL TECHNOLOGIES GMBH |
SUSANNE RAAB |
| K073196 |
11/13/2007 |
MASTER-VU |
SONOMED, INC. |
GEORGE MYERS |
| K070102 |
01/10/2007 |
SOPRO 162 CAMERA |
SOPRO |
STEVE SALESKY |
| K070304 |
01/31/2007 |
DIGORA PCT/DIGIPOD |
SOREDEX PALODEX GROUP OY |
KAI LANER |
| K073350 |
11/29/2007 |
SCANORA 3D |
SOREDEX PALODEX GROUP OY |
JOUNI ONNELA |
| K070303 |
01/31/2007 |
SILICONE TISSUE EXPANDER |
SPECIALTY SURGICAL PRODUCTS |
ANGELA LAWRENCE |
| K073351 |
11/29/2007 |
CRYSTAL |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K073348 |
11/29/2007 |
LUCENT MAGNUM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K073240 |
11/16/2007 |
PSS SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
| K073320 |
11/26/2007 |
CIMPLICITY SPINAL SYSTEM |
SPINE SMITH PARTNERS L.P. |
ROBERT JONES |
| K070245 |
01/25/2007 |
CAPSURE PEDICLE SCREW SYSTEM |
SPINE WAVE, INC. |
RONALD K SMITH |
| K073232 |
11/15/2007 |
INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX |
SPINEFRONTIER, INC. |
THOMAS A CARLSON |
| K073093 |
11/01/2007 |
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, |
SPIRE BIOMEDICAL INC |
RAYMOND KELLY |
| K073092 |
11/01/2007 |
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, |
SPIRE BIOMEDICAL INC |
RAYMOND KELLY |
| K070166 |
01/18/2007 |
STRADA CAROTID GUIDING SHEATH |
ST. JUDE MEDICAL |
JEFF STURM |
| K073244 |
11/19/2007 |
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES |
STERIS Corporation |
JOHN R SCOVILLE |
| K073361 |
11/30/2007 |
MUSCLE PAIN DEVICE (MPD) |
STEVENS PROOF OF CONCEPT, INC. |
JECKIN D SHAH |
| K070134 |
01/16/2007 |
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 |
STOCKERT GMBH |
DOMINIKA SCHULER |
| K070199 |
01/22/2007 |
RETIC-CHEX LINEARITY FOR BC |
Streck |
KERRIE OETTER |
| K073151 |
11/08/2007 |
MANTIS SPINAL SYSTEM |
STRYKER CORP. |
CURTIS TRUESDALE |
| K070078 |
01/09/2007 |
STRYKER T4 HYTREL TOGA |
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
PAULETTE D JOHNSON |
| K070170 |
01/18/2007 |
DALL-MILES SYSTEM |
STRYKER ORTHOPAEDICS |
PATRICIA SETTI-LAPERCH |
| K070219 |
01/23/2007 |
SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM |
SUNI MEDICAL IMAGING, INC. |
DAVID STARK |
| K070030 |
01/03/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
| K070038 |
01/03/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
| K070043 |
01/03/2007 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
| K070035 |
01/03/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVE |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
| K070040 |
01/03/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
| K070042 |
01/03/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW |
SUPER SAFE PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
| K073109 |
11/02/2007 |
STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM |
SURGICRAFT LTD. |
DONALD W GUTHNER |
| K070165 |
01/18/2007 |
ENSEAL PTC TRIO |
SURGRX, INC. |
LINDA OLESON |
| K070139 |
01/16/2007 |
WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 |
SURVIVAIR, INC. |
RICHARD O WOOD |
| K070092 |
01/10/2007 |
MODIFICATION TO VELASMOOTH, SHAPER |
SYNERON MEDICAL LTD. |
YONI IGER |
| K070089 |
01/09/2007 |
SYNTERMED LIVE |
SYNTERMED, INC. |
KENNETH F VAN TRAIN |
| K073303 |
11/23/2007 |
NORIAN DRILLABLE |
SYNTHES (USA) |
JEFFREY L DOW |
| K073115 |
11/05/2007 |
ORTHOMESH |
SYNTHES (USA) |
JEFFREY L DOW |
| K073135 |
11/07/2007 |
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS |
SYNTHES (USA) |
JILL SHERMAN |
| K073186 |
11/13/2007 |
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
| K070208 |
01/22/2007 |
SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K070294 |
01/31/2007 |
SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K070108 |
01/11/2007 |
ELIBRA DYNAMIC KNEE BALANCER |
SYNVASIVE TECHNOLOGY, INC. |
DANIEL KAMM |
| K073119 |
11/05/2007 |
CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
ERICA LI |
| K073311 |
11/23/2007 |
OSTEOTRANS-OT PIN |
TAKIRON CO., LTD |
KUMIHIRO HATA |
| K073312 |
11/23/2007 |
OSTEOTRANS-OT SCREW |
TAKIRON CO., LTD |
KUNIHIRO HATA |
| K073185 |
11/13/2007 |
APX21 |
TECHDENT TECHNOLOGIES, LTD. |
BENNY ARAZY |
| K073370 |
11/30/2007 |
TC MATRIX CLINICAL CHEMISTRY ANALYZER |
TECO DIAGNOSTICS |
JIM VAECHHES |
| K073094 |
11/01/2007 |
VITALLINK3 MOBILE VITAL SIGNS SYSTEM |
TELEMEDIC SYSTEMS LTD |
GERALD L BUSS |
| K070264 |
01/29/2007 |
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K070064 |
01/05/2007 |
AMYLASE EPS REAGENT |
Thermo Fisher Scientific |
MELITA LAMBIRIS |
| K073191 |
11/13/2007 |
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K073355 |
11/29/2007 |
CALCIUM, SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K073295 |
11/23/2007 |
UREA/BUN, SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K073141 |
11/07/2007 |
SPI ART ABUTMENT |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K070007 |
01/03/2007 |
SPI ELEMENT PLATFORM O 4.0 MM |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K070290 |
01/30/2007 |
SPI VECTODRILL CERAMIC DRILLS |
THOMMEN MEDICAL, AG |
Floyd Larson |
| K070024 |
01/03/2007 |
THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE |
THOR INTERNATIONAL |
M. JOYCE HEINRICH |
| K073272 |
11/21/2007 |
WORKSTATIONONE BREAST IMAGING WORKSTATION |
THREE PALM SOFTWARE, LLC |
HEIDI D ZHANG |
| K070215 |
01/23/2007 |
TOKUYAMA BOND FORCE |
TOKUYAMA DENTAL CORPORATION |
ROBERT A SILVERMAN |
| K073087 |
11/01/2007 |
NON-CONTACT TONOMETER, MODEL FT-1000 |
TOMEY CORPORATION |
KOJI KUBO |
| K073165 |
11/09/2007 |
DRAD-3000E, RADREX-I |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073081 |
11/01/2007 |
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073259 |
11/20/2007 |
XIDF-100A/B1 IMAGE PROCESSOR |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073147 |
11/08/2007 |
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 |
TRANSOMA MEDICAL |
LISA STONE |
| K073159 |
11/08/2007 |
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K070295 |
01/31/2007 |
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM |
TRINITY ORTHOPEDICS, LLC |
FLOYD G LARSON |
| K073097 |
11/01/2007 |
TUTODENT DENTAL MEMBRANE |
TUTOGEN MEDICAL U.S., INC. |
TRAVIS AROLA |
| K070118 |
01/12/2007 |
OTOGRAM, CA3350 |
TYMPANY, INC. |
LEX J PEARCE |
| K070162 |
01/17/2007 |
FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS |
VALLEYLAB,A DIVISION OF TYCO HEALTHCARE GROUP LP |
PHILIP E AKE |
| K070056 |
01/05/2007 |
VAPOTHERM MODEL# 2000I AND 2000H |
VAPOTHERM, INC. |
JOHNATHAN KAHAN |
| K073133 |
11/07/2007 |
INTERSTITIAL NEEDLES |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K070094 |
01/10/2007 |
TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K073241 |
11/16/2007 |
VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM |
VASCULAR PATHWAYS |
MARY PASCUAL GALLUP |
| K073264 |
11/20/2007 |
D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 |
VASCULAR SOLUTIONS, INC. |
JAMES CHAPMAN |
| K073200 |
11/13/2007 |
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
| K070216 |
01/23/2007 |
VARI-LASE BRIGHT TIP FIBER |
VASCULAR SOLUTIONS, INC. |
DEBORAH L NEYMARK |
| K073365 |
11/30/2007 |
DENTAL DIGITAL X-RAY IMAGING SYSTEM |
VATECH CO., LTD. |
STEPHEN T MLCOCH |
| K070248 |
01/25/2007 |
VELOCITYAIS |
VELOCITY MEDICAL SOLUTIONS, LLC |
PAUL SUMNER |
| K073338 |
11/28/2007 |
CELLSEARCH CIRCULATING TUMOR CELL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
| K070082 |
01/09/2007 |
XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY |
VERTEBRATION,INC |
BARBARA S FANT, PHARM.D. |
| K070218 |
01/23/2007 |
VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) |
VERTIFLEX (TM), INCORPORATED |
STEVE REITZLER |
| K073245 |
11/19/2007 |
EXTENDED VERTIFLEX SPINAL SCREW SYSTEM |
VERTIFLEX, INC. |
STEVE REITZLER |
| K073143 |
11/07/2007 |
MODIFIED VERTIFLEX SPINAL SCREW SYSTEM |
VERTIFLEX, INC. |
STEVE REITZLER |
| K070052 |
01/04/2007 |
MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION |
VILEX, INC. |
ABRAHAM LAVI |
| K070243 |
01/25/2007 |
SUTRALENE POLYPROPYLENE SUTURES |
VISIONARY MEDICAL SUPPLIES, INC. |
Gary Syring |
| K073279 |
11/21/2007 |
VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
| K073155 |
11/08/2007 |
VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) |
VITALOGRAPH(IRELAND) LTD. |
TOM J HEALY |
| K070055 |
01/04/2007 |
BONALIVE GRANULES AND BONALIVE PLATES |
VIVOXID LTD. |
CONSTANCE G BUNDY |
| K073261 |
11/20/2007 |
VAR MONITOR |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
JAMES LEE |
| K073352 |
11/29/2007 |
WEBERNEEDLE BASIC LASER |
WEBER MEDICAL GMBH |
JURGEN HERMANN |
| K070204 |
01/22/2007 |
LINK TO ACUITY CLINICIAN NOTIFIER |
WELCH ALLYN PROTOCOL, INC. |
JEFFREY WAGNER |
| K070060 |
01/05/2007 |
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) |
WELCH ALLYN, INC. |
JOHN SAWYER |
| K070128 |
01/16/2007 |
CO2 EASY |
Westmed, Inc. |
DALE BICKLEY |
| K073108 |
11/02/2007 |
ZENO ZR DISC |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K070149 |
01/16/2007 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K070145 |
01/16/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K073306 |
11/23/2007 |
XORANCONNECT |
XORAN TECHNOLOGIES, INC. |
AMY S KIM |
| K070010 |
01/03/2007 |
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER |
Z-MEDICA CORPORATION |
GIACOMO BASADONNA |
| K070006 |
01/03/2007 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. |
CHU XIAOAN |
| K070008 |
01/03/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. |
CHU XIAOAN |
| K073346 |
11/29/2007 |
ZIEHM VISION 2 |
ZIEHM IMAGING, INC. |
RICHARD WESTRICH |
| K070292 |
01/31/2007 |
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS |
ZIMMER GMBH |
ANTHONY FRANCALANCIA |
| K073347 |
11/29/2007 |
DYNESYS TOP-LOADING SPINAL SYSTEM |
ZIMMER SPINE, INC |
ELSA A LINKE |
| K073286 |
11/21/2007 |
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM |
ZIMMER, INC. |
BRANDON HIPSHER |
| K070214 |
01/23/2007 |
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM |
ZIMMER, INC. |
BRANDON HIPSHER |
| K070205 |
01/22/2007 |
ZIOSTATION |
ZIOSOFT, INC. |
MARC GOODMAN |
