| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K073284 |
12/14/2007 |
AIR-FLOW MASTER STANDARD |
(EMS SA) ELECTRO MEDICAL SYSTEMS |
SUSAN M BONAPACE |
| K072697 |
12/20/2007 |
3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES |
3T MEDICAL SYSTEMS, LLC |
ROBERT P EATON |
| K072637 |
12/11/2007 |
DIVO |
A2D IMAGING LLC |
DON WAUCHOPE |
| K070225 |
12/13/2007 |
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE |
ABIOMED, INC. |
ROBERT T KUNG |
| K072354 |
12/07/2007 |
GUIDEWIRE, MODEL G-V220-3527S AND OTHERS |
ACCELLENT INC. |
KARL STEINECK |
| K072836 |
12/27/2007 |
CHOLESTRAK HDL CHOLESTEROL HOME TEST |
ACCUTECH, LLC. |
Gary Lehnus |
| K071537 |
12/18/2007 |
STERRAD 100NX TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
REUBEN LAWSON |
| K073170 |
12/03/2007 |
R-PORT II LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
MARY MCNAMARA-CULLINANE |
| K073271 |
12/05/2007 |
ORTHOGON |
AGFA HEALTHCARE CORPORATION |
TOM HOLBROOK |
| K070722 |
12/14/2007 |
PLASMAIR, MODEL T2006 |
AIRINSPACE B.V. |
WADE TETSUKA |
| K071236 |
12/12/2007 |
ALCON MULTI-PURPOSE SOLUTION |
ALCON, INC. |
KIM B KRACKE |
| K071697 |
12/03/2007 |
NEURONAV SYSTEM AND NEURONAV DRIVE |
ALPHA OMEGA LTD. |
BAHEEJ DANIAL |
| K071164 |
12/07/2007 |
LIFE+CEL BATTERY |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
ALEX HENDERSON |
| K073125 |
12/05/2007 |
VALEO VBR |
AMEDICA CORP. |
ADAM HERDER |
| K063716 |
12/28/2007 |
AEROSOL SYSTEM |
AMICI, INC. |
MICHAEL BONO |
| K070873 |
12/19/2007 |
AMSURE BLADDER IRRIGATION SET |
AMSINO INTL., INC. |
YI CHEN |
| K072375 |
12/13/2007 |
SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET |
ANGIODYNAMICS, INC. |
BRIAN KUNST |
| K071746 |
12/13/2007 |
DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES |
ANSELL HEALTHCARE PRODUCTS, LLC |
CYNTHIA A INGRAM |
| K071671 |
12/28/2007 |
SCANSCOPE XT SYSTEM |
APERIO TECHNOLOGIES |
PERRY JOHNSTON |
| K072883 |
12/10/2007 |
ICE-SENSE |
ARBEL MEDICAL LTD. |
ZVI LADIN |
| K071616 |
12/19/2007 |
ARC SURGICAL BIOTRAK PIN SYSTEM |
ARC SURGICAL LLC. |
ED BOEHMER |
| K072137 |
12/07/2007 |
AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB |
AVITA CORPORATION |
JENNIFER REICH |
| K073205 |
12/19/2007 |
NIO 5MP, MODEL MDNG-5121 |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
NEIL PHILLIPS |
| K063845 |
12/07/2007 |
ADVIA CHEMISTRY TOTAL BILIRUBIN_2 |
BAYER HEALTHCARE, LLC |
PHILIP LIU |
| K072478 |
12/19/2007 |
BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K071026 |
12/20/2007 |
BD GENEOHM STAPHSR ASSAY |
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) |
RAYMOND BOULE |
| K073360 |
12/19/2007 |
PROPLATE |
BIO PROTECH, INC. |
E.J. Smith |
| K072553 |
12/14/2007 |
SYSTEM-ARMS, MODEL 390,E60 |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K072835 |
12/11/2007 |
LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK |
BIO-RAD, DIAGNOSTICS GRP. |
SUZANNE PARSONS |
| K072721 |
12/11/2007 |
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC |
BIO-RAD, DIAGNOSTICS GRP. |
ELIZABETH PLATT |
| K072068 |
12/21/2007 |
BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS |
BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC |
JONATHAN KAHAN |
| K072078 |
12/19/2007 |
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 |
BIOKIT S.A. |
JOAN GUIXER |
| K071210 |
12/19/2007 |
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
COURIVAUD CHRISTELLE |
| K070458 |
12/21/2007 |
MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
COURIVAUD CHRISTELLE |
| K072138 |
12/21/2007 |
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K063243 |
12/14/2007 |
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K073083 |
12/10/2007 |
VITEK 2 GRAM NEGATIVE PIPERACILLIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K072642 |
12/20/2007 |
BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS |
BIOMET 3I, INC. |
DIANA TAYLOR |
| K072804 |
12/12/2007 |
COMPREHENSIVE RS SHOULDER SYSTEM |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
| K072330 |
12/06/2007 |
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM |
BIOMET, INC. |
PAULA DEMING |
| K072344 |
12/03/2007 |
APL MEDICAL SYSTEM |
BIOS S.R.L. |
ALDO CASALINO |
| K072892 |
12/07/2007 |
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 |
BIOSITE INCORPORATED |
FIL V BUENVIAJE |
| K073230 |
12/20/2007 |
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K072765 |
12/12/2007 |
PASSEO 18 |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K072577 |
12/05/2007 |
BISICO IMPRESSION SILICONES & ALGINATES |
BISICO GMBH & CO KG |
DAGMAR MAESER |
| K071930 |
12/18/2007 |
ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C |
BLUE CROSS BIO-MEDICAL CO., LTD. |
HILDA HONG YANG |
| K072476 |
12/14/2007 |
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT |
Boston Scientific Corporation |
VIRGINIA CARR |
| K073199 |
12/21/2007 |
3M ESPE LAVA CHAIRSIDE ORAL SCANNER |
BRONTES TECHNOLOGIES |
JOHN GREENBAUM |
| K072453 |
12/03/2007 |
CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T |
BRYMILL CORP. |
STEPHEN WILLIAMS |
| K070582 |
12/07/2007 |
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS |
C.R. BARD, INC. |
SKIP RIMER |
| K070558 |
12/07/2007 |
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS |
C.R. BARD, INC. |
SKIP RIMER |
| K073423 |
12/19/2007 |
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER |
C.R. BARD, INC. |
SUSAN D SCOTT |
| K073226 |
12/07/2007 |
CINCH KNOTLESS FIXATION IMPLANT SYSTEM |
C2M MEDICAL, INC. |
GABRIELE G NIEDERAUER |
| K071995 |
12/18/2007 |
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K073123 |
12/06/2007 |
CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 |
CARDICA, INC. |
ISKRA MRAKOVIC |
| K073304 |
12/20/2007 |
CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES |
CARDICA, INC. |
ISKRA MRAKOVIC |
| K072105 |
12/28/2007 |
ALARIS SYSTEM WITH MMS, MODEL 8XXX |
CARDINAL HEALTH 303, INC. |
STACY L LEWIS |
| K071400 |
12/14/2007 |
SMARTSITE STOPCOCK |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
| K072558 |
12/05/2007 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 |
CARDIONET, INC |
JACK GAIKWAD |
| K072473 |
12/10/2007 |
CHASE MR SYSTEM |
CHASE MEDICAL, LP |
DAVID M HERNON |
| K072621 |
12/13/2007 |
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR |
CINCINNATI SUB-ZERO PRODUCTS, INC |
FATMA ALI |
| K071706 |
12/20/2007 |
ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) |
CLINICAL DATA, INC. |
WYNN STOCKING |
| K072796 |
12/18/2007 |
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K073009 |
12/07/2007 |
ONEPORT SURGICAL TROCAR SYSTEM |
CONMED CORPORATION |
BRIAN KILLORAN |
| K073378 |
12/28/2007 |
ADVANCE 18LP PTA DILATATION CATHETER |
COOK, INC. |
NATHAN SIMON |
| K072625 |
12/13/2007 |
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) |
COOK, INC. |
KAREN BRADBURN |
| K072537 |
12/18/2007 |
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM |
CREASPINE SAS |
CYNTHIA J.M NOLTE |
| K072518 |
12/20/2007 |
CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS) |
CRS MEDICAL DIAGNOSTICS INC. |
DANIEL KAMM |
| K070357 |
12/28/2007 |
FLEXCATH STEERABLE SHEATH & DILATOR |
CRYOCATH TECHNOLOGIES, INC. |
FRED MILDER |
| K072651 |
12/07/2007 |
CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM |
CSA MEDICAL, INC. |
JENNIFER CARTLEDGE |
| K072866 |
12/13/2007 |
ISSYS LP SPINAL FIXATION SYSTEM |
CUSTOM SPINE, INC. |
SAAD ATTIYAH |
| K072484 |
12/27/2007 |
CYNOSURE YAG FAMILY LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K073394 |
12/12/2007 |
SMARTLIPO LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K072587 |
12/10/2007 |
CYTORI AFT SYSTEM |
CYTORI THERAPEUTICS, INC. |
KENNETH KLEINHENZ |
| K072965 |
12/21/2007 |
DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
| K072717 |
12/12/2007 |
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 |
DADE BEHRING, INC. |
HELEN M LEE |
| K073117 |
12/19/2007 |
DENTIN DESENSITIZER AGENT |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K072832 |
12/14/2007 |
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K063686 |
12/20/2007 |
DEPUY LPS DISTAL FEMORAL COMPONENT |
DEPUY ORTHOPAEDICS, INC. |
REBECCA LENNARD |
| K073126 |
12/06/2007 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K072599 |
12/20/2007 |
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 |
DIADEXUS, INC. |
ROBERT WOLFERT PH.D |
| K071375 |
12/21/2007 |
MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
| K071679 |
12/17/2007 |
METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
YAEL RUBIN |
| K073518 |
12/20/2007 |
FLASHLITE REBEL* |
DISCUS DENTAL, INC. |
VIVIAN LAI |
| K071562 |
12/11/2007 |
D3 HEMATOLOGY ANALYZER, MODEL D3 |
DREW SCIENTIFIC, INC. |
ROGER BOURREE |
| K072146 |
12/18/2007 |
EMS PIEZON MASTER SURGERY |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
SUSAN BONAPACE |
| K073221 |
12/28/2007 |
CADENCE II |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K073340 |
12/19/2007 |
COLOR LCD MONITOR, FLEXSCAN MX300W |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K072159 |
12/27/2007 |
SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER |
EL.EN. ELECTRONIC ENGINEERING SPA |
ANDREA TOZZI |
| K072154 |
12/14/2007 |
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K072840 |
12/07/2007 |
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
| K060846 |
12/03/2007 |
THERAPEUTIC MASSAGE COMPANION |
ENDURANCE THERAPEUTICS |
BRAD BREZDEN |
| K072890 |
12/10/2007 |
STASILON FR |
ENTEGRION, INC. |
E.S. ESKRIDGE, JR. |
| K073399 |
12/21/2007 |
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE |
ENVISIONEERING, LLC. |
DAVID KENNEDY |
| K070053 |
12/03/2007 |
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K072231 |
12/26/2007 |
THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) |
ESM TECHNOLOGIES, LLC. |
CLIFF TRIBUS |
| K072555 |
12/13/2007 |
EDTA PLUS |
ESSENTIAL DENTAL SYSTEMS, INC. |
BRIAN RASIMICK |
| K072475 |
12/21/2007 |
BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) |
ETAC SVERIGE AB |
IAN GORDON |
| K070789 |
12/31/2007 |
EUROIMMUN ANTI-CCP ELISA |
EUROIMMUN US LLC |
KATHRYN KOHL |
| K073251 |
12/14/2007 |
HYALOMATRIX PA |
FIDIA ADVANCED BIOPOLYMERS SRL |
SHARON A SEGAL |
| K072776 |
12/07/2007 |
THE CROSSER SYSTEM |
FLOWCARDIA, INC. |
Dustin Michaels |
| K063642 |
12/13/2007 |
FD EMS, MODEL # D-FJ30E |
FUJI DYNAMICS LIMITED |
IRENE CHEUNG |
| K062580 |
12/21/2007 |
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) |
GE HEALTHCARE |
JOEL KENT |
| K072976 |
12/20/2007 |
MODEL 250CX SERIES MATERNAL/FETAL MONITOR |
GE HEALTHCARE |
AGATA SMIEJA |
| K073408 |
12/19/2007 |
GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
NICOLE LANDREVILLE |
| K073297 |
12/18/2007 |
GE LOGIQ P6 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K071781 |
12/19/2007 |
PF4 IGG |
GENETIC TESTING INSTITUTE |
SUZETTE C CHANCE |
| K073172 |
12/13/2007 |
BEACON STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K071187 |
12/20/2007 |
MICROFUSE BONE VOID FILLER |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K072513 |
12/07/2007 |
DM-EMG |
GVP ELETTRONICA SRL |
JOHN ROMANO |
| K072594 |
12/13/2007 |
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM |
GYRUS ACMI, INC. |
GRAHAM A BAILLIE |
| K073237 |
12/27/2007 |
REHASTIM & REHAMOVE |
HASOMED GMBH |
MATTHIAS WEBER |
| K073044 |
12/07/2007 |
HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
| K071150 |
12/12/2007 |
TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR MAESER |
| K072690 |
12/07/2007 |
HEMAWAY SEAT |
HEMAWAY LLC |
ARCHIE ROSENBLUM |
| K073059 |
12/10/2007 |
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM |
HITACHI, LTD., POWER SYSTEMS GROUP |
JONATHAN S KAHAN |
| K043617 |
12/21/2007 |
IMAGECHECKER CT CAD SOFTWARE SYSTEM |
HOLOGIC, INC. |
ARTHUR FRIEDMAN |
| K072631 |
12/20/2007 |
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
| K072547 |
12/19/2007 |
JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
| K073033 |
12/10/2007 |
LEGACY DENTAL IMPLANTS |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K073049 |
12/13/2007 |
SCREWPLUS DENTAL IMPLANTS (HA) |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K072660 |
12/12/2007 |
ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 |
IMTEC CORP. |
J. BRAD VANCE |
| K073367 |
12/27/2007 |
HEMOSIL FIBRINOGEN-C |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K072929 |
12/07/2007 |
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 |
INTEGRA LIFESCIENCES CORPORATION |
DARLENE M WELSH |
| K071928 |
12/12/2007 |
THE INVACARE FLYER, MODEL IPC 100 |
INVACARE CORP. |
CARROLL MARTIN |
| K072911 |
12/13/2007 |
ION MEDICAL BIPOLAR COAGULATION PEN |
ION MEDICAL, LLC |
KEITH HURON |
| K072640 |
12/21/2007 |
IRISPEC,CA/CB/CC |
IRIS DIAGNOSTICS |
GERALD HADDOCK |
| K070021 |
12/07/2007 |
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 |
| K072788 |
12/26/2007 |
STORZ MODULITH LITHOTRIPTER SLX-F2-F180 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
| K071695 |
12/31/2007 |
KENSEY NASH MACROPORE SHIELD |
KENSEY NASH CORP. |
CINDY VARUGHESE |
| K072622 |
12/04/2007 |
STANDOUT 2 |
KERR CORP. |
Wendy Garman |
| K072764 |
12/20/2007 |
KLS MARTIN XTERNAL FIXATOR |
KLS MARTIN L.P. |
TOM FAUCETT |
| K072707 |
12/19/2007 |
PATIENT CONTOURED MESH-PEEK (PCM-P) |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
| K070012 |
12/27/2007 |
POLYBONE |
KYUNGWON MEDICAL CO., LTD. |
JOO YEON LEE |
| K071905 |
12/28/2007 |
POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
LANX, LLC |
JANICE M HOGAN |
| K072995 |
12/18/2007 |
TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER |
LUMEN DEVELOPMENT AND MANUFACTURING, INC. |
CALVIN D OSTLER |
| K073436 |
12/28/2007 |
SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K073248 |
12/12/2007 |
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K072360 |
12/12/2007 |
K-Y BRAND INTRIGUE INTENSE WARMING SENSATION |
MCNEIL-PPC, INC. |
NADER FOTOUHU, PH.D. |
| K071878 |
12/07/2007 |
DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB |
MED-LECTRIC CORPORATION |
M. LEE GUNTER |
| K072550 |
12/07/2007 |
SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301 |
MEDEVICE, INC. |
MICHELE H VOVOLKA |
| K072226 |
12/10/2007 |
IMPIX SPACER |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K072511 |
12/13/2007 |
SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM |
MEDIMOP MEDICAL PROJECTS, LTD. |
ARI Y SOBEL |
| K072759 |
12/13/2007 |
VIAL2BAG |
MEDIMOP MEDICAL PROJECTS, LTD. |
ARI Y SOBEL |
| K072886 |
12/21/2007 |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T |
MEDRAD, INC. |
LISA M CASAVANT |
| K072328 |
12/21/2007 |
MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K071942 |
12/11/2007 |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MICHELLE WILLIS |
| K070356 |
12/18/2007 |
MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM |
MEDWAVES INCORPORATED |
TED ORMSBY |
| K073456 |
12/20/2007 |
T-QUEST SYSTEM |
MEDX, INC. |
MICHAEL HANUSHEWSKY |
| K071941 |
12/04/2007 |
MEMOMETAL BONE ANCHORS |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
| K072823 |
12/14/2007 |
MERILAS 532A |
MERIDIAN AG |
Kevin Walls |
| K072552 |
12/14/2007 |
MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE |
MERIT MEDICAL SYSTEMS, INC. |
WILLIAM D JORDAN |
| K073397 |
12/20/2007 |
MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K073398 |
12/20/2007 |
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K073300 |
12/04/2007 |
MILESMAN PREMIUM |
MILESMAN S.L. |
NATALYA VALERIO |
| K072979 |
12/26/2007 |
SPIROBANK G |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
| K073448 |
12/20/2007 |
MEDICAL DISPLAY, MD205MG |
NEC DISPLAY SOLUTIONS, LTD. |
SHUICHI KINO |
| K070899 |
12/13/2007 |
PURITAN BENNETT LEGENDAIR XL2 |
NELLCOR PURITAN BENNETT |
JAMES BONDS |
| K071691 |
12/19/2007 |
DUAL SHOT ALPHA |
NEMOTO KYORINDO CO., LTD. |
MICHAEL HIEDA |
| K072997 |
12/19/2007 |
NEOMED URINARY CATHETER |
NEOMED, INC. |
PENNY NORTHCUTT |
| K071613 |
12/14/2007 |
AMIGO INSULIN PUMP |
NIPRO DIABETES SYSTEMS, INC. |
HARRY RUSSELL |
| K072570 |
12/28/2007 |
NOBELACTIVE MULTI UNIT ABUTMENT |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K070857 |
12/28/2007 |
NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K072980 |
12/20/2007 |
NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS |
NOBEL BIOCARE AB |
KAM LEUNG |
| K073273 |
12/11/2007 |
EQUAL DOSE 1.0 |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K073107 |
12/07/2007 |
VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 |
NUCLETRON CORPORATION |
LISA] DIMMICK |
| K063304 |
12/21/2007 |
LIFE4C |
NUMEDIS, INC. |
MARY E FREDDO |
| K071795 |
12/04/2007 |
NUVASIVE COROENT SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K072937 |
12/28/2007 |
OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET |
OLSEN MEDICAL |
JOHN P WATERS |
| K073409 |
12/14/2007 |
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K073045 |
12/18/2007 |
SAPPHIRE CERAMIC BRACKET |
ORTHO TECHNOLOGY, INC |
PAUL WILLIAMS |
| K073157 |
12/07/2007 |
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE HANNA |
| K072601 |
12/10/2007 |
OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT |
OSTEOSYMBIONICS, LLC |
CYNTHIA M BROGAN |
| K072670 |
12/13/2007 |
MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER |
PARI INNOVATIVE MANUFACTURERS, INC. |
JAMES MCINTIRE |
| K071063 |
12/20/2007 |
LINASYS |
PATHFINDER THERAPEUTICS, INC. |
JAMES D STEFANSIC |
| K072830 |
12/04/2007 |
RM BOND, MODEL J032 |
PENTRON CLINICAL TECHNOLOGIES |
GREG MOREAU |
| K072718 |
12/28/2007 |
PENUMBRA SYSTEM |
PENUMBRA, INC. |
THERESA BRANDNER-ALLEN |
| K073210 |
12/12/2007 |
MODIFICATION TO: T-PORT HP INFUSION PORT |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K072393 |
12/07/2007 |
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 |
PHADIA US INC. |
MARTIN R MANN |
| K070009 |
12/07/2007 |
AT HOME DRUG TEST MODELS, 9308T AND 9308X |
PHAMATECH INC. |
CARL MONGIOVI |
| K070098 |
12/07/2007 |
QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC |
PHAMATECH INC. |
CARL MONGIOVI |
| K072813 |
12/28/2007 |
EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) |
PHASEIN AB |
DAVID WEISSBURG |
| K071885 |
12/20/2007 |
ANTIMICROBIAL AND SINGLE-PATIENT CUFFS |
PHILIPS MEDICAL SYSTEMS |
PETER SCHIPELLITI |
| K072376 |
12/12/2007 |
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS |
PLAYTEX PRODUCTS, INC. |
KEITH EDGETT |
| K070757 |
12/04/2007 |
MICROPROTEIN REAGENT SET |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
| K072766 |
12/11/2007 |
PVMED DDR 2520 DIGITAL IMAGING SYSTEM |
PORTAVISION MEDICAL |
IAN GORDEN |
| K073001 |
12/18/2007 |
IDRIVES, IDRIVEC, IDRIVEF |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K073148 |
12/07/2007 |
IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K072267 |
12/10/2007 |
TOTAL HIP SURGETICS NAVIGATION SYSTEM |
PRAXIM SA |
JIHANE ZEMMOURI |
| K073220 |
12/19/2007 |
THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT |
PRESTIGE BRANDS, INC. |
KAREN A COSTA-STRACHAN |
| K072261 |
12/26/2007 |
FINESSE SYSTEM |
PRIMAEVA MEDICAL, INC. |
SEVRINA CIUCCI |
| K073353 |
12/07/2007 |
DO-ALL DENTAL HANDPIECE LUBRICANT |
PRODRIVE SYSTEMS, INC. |
TIMOTHY F NASON |
| K072756 |
12/19/2007 |
NON-IV ADAPTER FOR INFANT NG TUBE |
PROMEDIC, INC. |
PAUL DRYDEN |
| K072528 |
12/28/2007 |
ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES |
PROSURG, INC. |
ASHVIN DESAI |
| K072264 |
12/06/2007 |
FASTPACK HCG IMMUNOASSAY |
Qualigen, Inc. |
MICHAEL S POIRIER |
| K073066 |
12/26/2007 |
308 DERMATOLOGICAL EXCIMER SYSTEM |
QUANTEL MEDICAL, INC. |
GEORGE MYERS |
| K073178 |
12/27/2007 |
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 |
R & D SYSTEMS, INC. |
NANCY C RING |
| K072940 |
12/13/2007 |
MIRAGE MICRO |
RESMED LTD. |
DAVID D'CRUZ |
| K072450 |
12/12/2007 |
ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 |
RESPIRONICS CALIFORNIA, INC. |
MARA CALER |
| K072588 |
12/18/2007 |
PERFORMAX SE TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA YURKO |
| K072592 |
12/19/2007 |
PERFORMAX TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA YURKO |
| K072996 |
12/27/2007 |
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
| K072654 |
12/14/2007 |
PATIENT SAFE SYRINGE |
RETRACTABLE TECHNOLOGIES, INC. |
RHONDA WELLS |
| K071093 |
12/06/2007 |
SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202 |
SAN SHIH ELECTRICAL ENTERPRISE CO., LTD. |
Ke-Min Jen |
| K072374 |
12/07/2007 |
COMPASS |
SCANDITRONIX WELLHOFER GMBH |
MARTIN AROLD |
| K072466 |
12/19/2007 |
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 |
SCICAN LTD. |
TERESA BOYCE |
| K073043 |
12/14/2007 |
SET PP |
SDI LTD. |
RAY CAHILL |
| K072605 |
12/20/2007 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
ETHEL BERNAL |
| K070486 |
12/21/2007 |
CAPILLARYS URINE (PN 2012) |
Sebia, Inc. |
KAREN ANDERSON |
| K073127 |
12/20/2007 |
BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
Diana Hong |
| K071353 |
12/14/2007 |
FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C |
SHANGHAI FOSHION MEDICAL INSTRUMENTS CO., LTD. |
WILLIAM MCLAIN |
| K071886 |
12/27/2007 |
SELF SEAL STERILIZATION POUCH |
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. |
LONGFU SONG |
| K073193 |
12/20/2007 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD |
CHU XIAOAN |
| K073373 |
12/18/2007 |
SYNGO VOLUME PERFUSION-CT BODY |
SIEMENS AG, MEDICAL SOLUTIONS |
RALF HOFMANN |
| K072676 |
12/18/2007 |
ACUSON X300 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MARTINA VOGT |
| K072485 |
12/27/2007 |
ARTISTE MV SA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ERIK RODRIGUEZ |
| K071730 |
12/20/2007 |
STUDIODOP VICORDER |
SKIDMORE MEDICAL, LIMITED |
DAVID W WAGNER |
| K073040 |
12/13/2007 |
SMH FLEX S |
SMH BIOMATERIAL AG |
ASHLEY TRUITT |
| K072785 |
12/10/2007 |
TWINFIX FT PK |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
DEANA BOUSHELL |
| K073175 |
12/20/2007 |
JOURNEY UNICONDYLAR FEMORAL IMPLANT |
SMITH & NEPHEW, INC. |
MARLON RIDLEY |
| K073325 |
12/20/2007 |
LEGION POROUS PRIMARY |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K072531 |
12/06/2007 |
LEGION STEM WITH HOLES |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K072657 |
12/14/2007 |
POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS |
SMITHS MEDICAL MD, INC. |
BRIAN HAUGSTAD |
| K072951 |
12/19/2007 |
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES |
SOFRADIM PRODUCTION |
SHARON ALEXANDER |
| K073196 |
12/19/2007 |
MASTER-VU |
SONOMED, INC. |
GEORGE MYERS |
| K070783 |
12/13/2007 |
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR |
SOPRO |
STEVE SALESKY |
| K073350 |
12/19/2007 |
SCANORA 3D |
SOREDEX PALODEX GROUP OY |
JOUNI ONNELA |
| K072750 |
12/04/2007 |
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 |
SPECTRANETICS CORP. |
MICHAEL K HANDLEY |
| K073348 |
12/26/2007 |
LUCENT MAGNUM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K072961 |
12/19/2007 |
LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) |
SRA DEVELOPMENTS, LTD. |
MICHAEL J.R. YOUNG |
| K071818 |
12/20/2007 |
ENSITE FUSION DYNAMIC REGISTRATION TOOL |
ST. JUDE MEDICAL |
KAREN J MCKELVEY |
| K072510 |
12/11/2007 |
VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2 |
STERIS Corporation |
JOHN ROBERT SCOVILLE |
| K073151 |
12/06/2007 |
MANTIS SPINAL SYSTEM |
STRYKER CORP. |
CURTIS TRUESDALE |
| K072271 |
12/18/2007 |
STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE |
STRYKER CORP. |
BECKY DITTY |
| K072118 |
12/07/2007 |
STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT |
STRYKER CORP. |
JEAN SHEPPARD |
| K071482 |
12/20/2007 |
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 |
SYNERGETICS, INC |
DAN REGAN |
| K072758 |
12/18/2007 |
SYNTHES (USA) 2.0MM TITANIUM T-PLATE |
SYNTHES (USA) |
ANDREA M TASKER |
| K073186 |
12/17/2007 |
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
| K072791 |
12/26/2007 |
ORACLE SPACER, OPAL SPACER |
SYNTHES SPINE |
STACEY BONNELL |
| K073372 |
12/07/2007 |
ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) |
SYSTEMSONE |
THOMAS ARTHUR |
| K072784 |
12/21/2007 |
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
ERICA LI |
| K072273 |
12/20/2007 |
BELMONT QUOLIS 5000 SERIES DENTAL UNIT |
TAKARA BELMONT USA, INC. |
ROBERT SCHIFF |
| K071712 |
12/04/2007 |
LEUKO EZ VUE |
TECHLAB INC., CORPORATE RESEARCH CENTER |
CHARLES PENNINGTON |
| K071349 |
12/12/2007 |
NEUROSIGN LARYNGEAL ELECTRODES |
THE MAGSTIM COMPANY LTD. |
ANWEN EVANS |
| K072407 |
12/21/2007 |
BODYFORM THORACIC FIXATION SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K070824 |
12/03/2007 |
CREATININE (ENZYMATIC) |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K073141 |
12/05/2007 |
SPI ART ABUTMENT |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K072649 |
12/06/2007 |
SPI SYSTEM DENTAL IMPLANTS |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| K073272 |
12/11/2007 |
WORKSTATIONONE BREAST IMAGING WORKSTATION |
THREE PALM SOFTWARE, LLC |
HEIDI D ZHANG |
| K072746 |
12/04/2007 |
E-1 ESTHETIC COMPOSITE SYSTEM |
TOKUYAMA DENTAL CORPORATION |
KEITH A BARRITT |
| K073259 |
12/20/2007 |
XIDF-100A/B1 IMAGE PROCESSOR |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073147 |
12/03/2007 |
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 |
TRANSOMA MEDICAL |
LISA STONE |
| K071876 |
12/17/2007 |
CROSS.BONE |
TRIMED, INC. |
KELLI ANDERSON |
| K073020 |
12/19/2007 |
ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K073264 |
12/07/2007 |
D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 |
VASCULAR SOLUTIONS, INC. |
JAMES CHAPMAN |
| K072810 |
12/19/2007 |
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 |
VASCULAR SOLUTIONS, INC. |
DORALIE POGANSKI |
| K073400 |
12/20/2007 |
VARICATH PERIPHERAL INFUSION CATHETER |
VEINRX INC. |
GREGORY MATHISON |
| K072180 |
12/18/2007 |
VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K072009 |
12/14/2007 |
WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340 |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
ECKHARDT ALBERS |
| K070060 |
12/18/2007 |
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) |
WELCH ALLYN, INC. |
JOHN SAWYER |
| K072168 |
12/19/2007 |
OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSIEH |
| K072377 |
12/14/2007 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN-HUI HUANG |
| K072314 |
12/12/2007 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN- HUI HUANG |
| K071122 |
12/12/2007 |
DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN-HUI HUANG |
| K072878 |
12/03/2007 |
MODIFICATION TO: LOCATOR IMPLANT ANCHOR |
ZEST ANCHORS, INC. |
RICHARD OVERTON |
| K071219 |
12/06/2007 |
ATHENA MULTI-LYTE GBM TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K073005 |
12/12/2007 |
ELITE GLASS |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
