FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K131404 |
05/30/2013 |
FLASH AR PENTA / FLASH AR PENTA QUICK |
3M DEUTSCHLAND GMBH |
DESI W SOEGIARTO |
K123115 |
05/20/2013 |
ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P |
ACME FILTER MASK INC. |
JEN KE-MIN |
K130474 |
05/31/2013 |
SURGISEAL TOPICAL SKIN ADHESIVE |
Adhezion Biomedical, LLC |
Caridad Smith |
K130954 |
05/31/2013 |
ARS SCREW; SLANT SCREW |
ADVANCED INTERVENTIONAL TECHNOLOGY, LLC |
EDUARDO MARCH |
K123133 |
05/22/2013 |
BARLE TISSUE ADHESIVE |
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
MICHAEL BROWNE |
K123569 |
05/24/2013 |
ANTEGRADE FEMORAL NAIL |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
JULIE GLENDRANGE |
K121976 |
05/17/2013 |
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE |
AESCULAP, INC. |
KATHY A RACOSKY |
K120615 |
05/15/2013 |
ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE |
ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN |
EDWARD BREHM, PH.D. |
K123953 |
05/02/2013 |
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ PH.D. |
K123322 |
05/21/2013 |
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT |
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC |
HYMAN KATZ PH.D. |
K131119 |
05/21/2013 |
SOLANAS POSTERIOR STABILIZATION SYSTEM |
ALPHATEC SPINE, INC. |
TREVOR DENBO |
K122978 |
05/23/2013 |
SANICLAVE 102, MODEL RS-SC-102 |
ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT |
ISAAC ERICKSON |
K123746 |
05/24/2013 |
AMES THERAPY DEVICE |
AMES TECHNOLOGY, INC. |
SHEILA RAMERMAN, RAC |
K123823 |
05/31/2013 |
INTERLIG |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
LILIAN LLULL |
K130538 |
05/22/2013 |
WINX SLEEP THERAPY SYSTEM |
APNICURE, INC. |
CHRIS DANIEL |
K130192 |
05/10/2013 |
NEXTSTEP RETROGRADE |
ARROW INTERNATIONAL, INC. |
GWEN TASCHNER |
K130458 |
05/03/2013 |
KNOTLESS FIBERTAK SUTURE ANCHOR |
ARTHREX, INC. |
CHRISTINA FLORES |
K130129 |
05/31/2013 |
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM |
ARTHREX, INC. |
COURTNEY SMITH |
K122416 |
05/03/2013 |
ARTIGLASS L. O.R. GLASS SYRINGE |
ARTIGLASS SRL |
FEDERICO BACCARIN |
K123937 |
05/23/2013 |
ATOM TRANSCAPSULE V-707 |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
K131107 |
05/14/2013 |
ATRICLIP GILLINOV-COSGROVE LAA CLIP |
ATRICURE, INC. |
REBECCA WALTERS |
K130498 |
05/31/2013 |
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY |
BACTERIN INTERNATIONAL INC. |
HOWARD L SCHRAYER |
K131246 |
05/24/2013 |
CORONIS 3MP |
BARCO N.V. |
LIEVEN DE WANDEL |
K131295 |
05/29/2013 |
NIO COLOR 3MP LED |
BARCO NV |
LIEVEN DE WANDEL |
K131199 |
05/30/2013 |
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER |
BARD PERIPHERAL VASCULAR, INC. |
MARIO THOMAS |
K123736 |
05/16/2013 |
CRYSTALSERT DELIVERY SYSTEM |
BAUSCH & LOMB |
JASON SMITH |
K123903 |
05/13/2013 |
BD BACTEC LYTIC/10 ANAEROBIC/F (PLASTIC) |
BECTON DICKINSON & CO. |
Paul Swift |
K123871 |
05/10/2013 |
FINGERTIP PULSE OXIMETER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
K131299 |
05/22/2013 |
ANYTHINK PACS WORKSTATION |
BEIJING CREALIFE TECHNOLOGY CO., LTD. |
WEIHUA ZHOU |
K123710 |
05/09/2013 |
UNITOX BOTOX SYRINGE |
BIO-MED USA INC |
YOUNG CHI |
K130963 |
05/06/2013 |
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK |
BIO-RAD LABORATORIES, INC. |
SUZANNE PARSONS |
K130990 |
05/09/2013 |
VARIANT(TM) II TURBO HBA1C KIT - 2.0 |
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
EBONY MCKINNIES |
K122559 |
05/03/2013 |
BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS |
BIODENTA SWISS AG |
DAVID EILER |
K123491 |
05/30/2013 |
BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT |
BIODENTA SWISS AG |
DAVID EILER |
K122368 |
05/02/2013 |
WATERLASE IPLUS ALL TISSUE LASER |
BIOLASE TECHNOLOGY, INC. |
EHAB ESMAIL |
K124022 |
05/14/2013 |
SPEED SHIFT |
BIOMEDICAL ENTERPRISES, INC |
JOE SOWARD |
K123636 |
05/01/2013 |
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE |
BIONESS, INC. |
KIM TOMPKINS |
K131136 |
05/31/2013 |
GLUCOSE METER-CHECK SOLUTION FOR TAIDOC |
BIONOSTICS, INC. |
RANDY BYRD |
K122525 |
05/02/2013 |
SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM |
Biotest Medical Corp. |
AMANDA CHIANG |
K122196 |
05/02/2013 |
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY |
BLACKROCK NEUROMED, LLC |
JOHN ZIOBRO |
DEN120022 |
05/09/2013 |
X-RAY ATTENUATING CREAM |
BLOXR CORPORATION |
RAI CHOWDHARY |
K123380 |
05/31/2013 |
STRIDE UNICONDYLAR KNEE |
BLUE BELT TECHNOLOGIES, INC. |
RICK CONFER |
K123821 |
05/17/2013 |
AIO HD OTOSCOPE |
BLUE FOCUS |
KI CHEOL HAN |
K130909 |
05/16/2013 |
GATEWAY ADVANAGE Y-ADAPTER |
BOSTON SCIENTIFIC CORP. |
CHRISTINE SHOEMAKER |
K130804 |
05/22/2013 |
UROMAX ULTRA BALLOON DILATATION CATHETER |
Boston Scientific Corporation |
LAUREN RUSSO |
K130037 |
05/17/2013 |
BREATHE CPAP SYSTEM |
BREATHE TECHNOLOGIES, INC. |
CRAIG COOMBS |
K130366 |
05/15/2013 |
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT |
C.R. BARD, INC. |
Joni Creal |
K130786 |
05/03/2013 |
SLEEK OTW PTA CATHETER |
C.R. BARD, INC. |
FIONA NI MHULLAIN |
K130968 |
05/01/2013 |
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM |
C.R. BARD, INC. |
KETI SINO |
K131045 |
05/29/2013 |
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE |
CARDIAC DESIGNS, LLC |
RAYMOND J KELLY, IV |
K130288 |
05/29/2013 |
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE |
CARDIAC INSIGHT, INC. |
DEBORAH SHEFFIELD |
K130411 |
05/29/2013 |
740 SELECT |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
K123381 |
05/10/2013 |
HYPERION X9 |
CEFLA S.C. |
BERTHOIN CLAUDE |
K130551 |
05/22/2013 |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
HYE-JOO KIM, PHARM. D. |
K123844 |
05/30/2013 |
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST |
CHEMTRON BIOTECH, INC. |
Jane Zhang |
K130481 |
05/24/2013 |
SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK |
CIRCADIANCE LLC |
RYAN T KASUN |
K120900 |
05/31/2013 |
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 |
CLINIQA CORPORATION |
DAWN GAST |
K131019 |
05/24/2013 |
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA SHAH |
K130293 |
05/31/2013 |
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
COOK, INC. |
DAVID E CHADWICK |
K130444 |
05/22/2013 |
H-30 HOLMIUM LASER SYSTEM |
COOK, INC. |
SUSANNE GALIN |
K123202 |
05/30/2013 |
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS |
COOPERVISION, INC. |
KARIN GASTINEAU |
K131225 |
05/29/2013 |
ADROIT GUIDING CATHETER |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
MARY E HOLDEN |
K130634 |
05/24/2013 |
CORIN METAFIX HIP STEM |
CORIN U.S.A. |
LUCINDA GERBER |
K130343 |
05/28/2013 |
CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS |
CORIN U.S.A. |
DIANA L MARTONE |
K120671 |
05/17/2013 |
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) |
COTRONIC TECHNOLOGY LIMITED |
TANI MOK |
K130796 |
05/09/2013 |
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM |
COVIDIEN |
KELSEY LEE |
K123581 |
05/09/2013 |
NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. |
MIA M WARE |
K130532 |
05/30/2013 |
IDRIVE ULTRA STERILIZATION TRAY |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
KATHERINE ROBERTSON |
K122974 |
05/17/2013 |
TRYOUT-VPS HOLDING PASTE |
CROWN DELTA CORP. |
MARK KONOPKA |
K120597 |
05/03/2013 |
KOMPREDA |
CUSTOM SPINE, INC. |
DAVID BRUMFIELD |
K122493 |
05/15/2013 |
GENESISPLUS |
CUTERA, INC. |
Connie Hoy |
K123971 |
05/02/2013 |
CYNOSURE 1064NM DIODE LASER |
CYNOSURE, INC. |
IRINA KULINETS |
K131020 |
05/09/2013 |
TEMPERATURE SENSOR CATHETER |
DEGANIA SILICONE, LTD. |
ZOYA LEE |
K130216 |
05/01/2013 |
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT |
DENTSPLY IMPLANT |
LINDA K SCHULZ |
K123925 |
05/24/2013 |
MTM CLEAR ALIGNER IN-OFFICE |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
K130169 |
05/01/2013 |
FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
SUSAN KAGAN |
K130917 |
05/24/2013 |
HEALIX ADVANCE KNOTLESS BR ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
YAYOI FUJIMAKI |
K130539 |
05/21/2013 |
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
JULIE VAFIDES |
K130105 |
05/17/2013 |
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
JULIE VAFIDES |
K122595 |
05/01/2013 |
HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM |
DERMAL LIFE LLC |
DIANE HORWITZ, PH.D., RAC |
K122519 |
05/21/2013 |
DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM |
DIO CORPORATION |
TIMOTHY LEE |
K124016 |
05/06/2013 |
EMPI PHOENIX |
DJO, LLC |
KEN FISHER |
K130729 |
05/14/2013 |
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER |
DORNIER MEDTECH SYSTEMS |
JOHN HOFFER |
K123084 |
05/23/2013 |
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD |
ELCAM MEDICAL A.C.A.L. |
AHARON COHEN |
K130354 |
05/29/2013 |
MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) |
ENTRIGUE SURGICAL, INC. |
GABRIELE G NIEDERAUER |
K130922 |
05/17/2013 |
ERCHONIA VERJU LASER SYSTEM WITH MASSAGER |
ERCHONIA MEDICAL, INC. |
Kevin Walls |
K131392 |
05/29/2013 |
ETIAM PACS COMPONENTS |
ETIAM S.A.S.U. |
GERALDINE TESSENS |
K121467 |
05/10/2013 |
EUROTROL HEMATOCRIT CONTROL |
EUROTROL B.V. |
PAUL B.P. KOOIJMANS |
K130911 |
05/24/2013 |
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER |
EV3 INC. |
LAURA J LIND |
K130434 |
05/01/2013 |
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC |
EXACTECH, INC. |
PATRICK HUGHES |
K130524 |
05/22/2013 |
BREATHID HP SYSTEM |
EXALENZ BIOSCIENCE LTD. |
CLAY ANSELMO |
K123079 |
05/08/2013 |
OLYMPIC BRAINZ MONITOR |
EXCEL-TECH LTD. (XLTEK) |
DANIEL RAMIREZ |
K123041 |
05/29/2013 |
VASOSTAT HEMOSTASIS DEVICE |
FORGE MEDICAL INC. |
MASON DIAMOND |
K121613 |
05/01/2013 |
AGILIA INFUSION SYSTEM |
FRESENIUS KABI AG |
CHERYL ROSCHER |
K130039 |
05/02/2013 |
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
K131118 |
05/16/2013 |
4D VIEW |
GE HEALTHCARE |
BRYAN BEHN |
K123603 |
05/17/2013 |
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME |
GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC |
GERALD BUSS |
K130626 |
05/01/2013 |
MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
PHILIP MALCA |
K130115 |
05/23/2013 |
DISCOVERY MR750W 3.0T |
GE MEDICAL SYSTEMS, LLC |
MICHELLE HUETTNER |
K120532 |
05/02/2013 |
GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM |
GETINGE SOURCING LLC |
BARB SMITH |
K122625 |
05/22/2013 |
GETINGE 800HC- SERIES STEAM STERILIZER |
GETINGE SOURCING LLC |
BARB SMITH |
K130624 |
05/07/2013 |
CONI |
GLOBALMED |
NICHOLAS CAMPBELL |
K124058 |
05/13/2013 |
CREO STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
SARAH M FITZGERALD |
K123913 |
05/13/2013 |
LATIS SPACER |
GLOBUS MEDICAL INC. |
CHRISTINA KICHULA |
K130559 |
05/24/2013 |
MOBICATH BI-DIRECTIONAL GUIDING SHEATH |
Greatbatch Medical |
DENISE THOMPSON |
K122705 |
05/21/2013 |
HUMICARE D900 |
GRUNDLER GMBH |
JIM CASSI |
K130311 |
05/30/2013 |
TRANSTEK BODY FAT ANALYZER |
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
LEO WANG |
K131232 |
05/31/2013 |
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K123368 |
05/07/2013 |
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
K131121 |
05/29/2013 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR |
HEALTH & LIFE CO., LTD. |
SARAH SU |
K123077 |
05/14/2013 |
VASCULAR CLAMPS |
HEBU MEDICAL GMBH |
ANGELIKA SCHERP |
K130647 |
05/17/2013 |
XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML |
HERAEUS KULZER, LLC |
JAMIE MEARNA |
K130870 |
05/02/2013 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERIKA AMMIRATI |
K130277 |
05/31/2013 |
SINGLE ENERGY (SE) FEMUR EXAMS |
HOLOGIC, INC. |
EILEEN M BOYLE |
K121719 |
05/10/2013 |
SM TENS & PMS |
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED |
DORIS DONG |
K122721 |
05/03/2013 |
AG GUFFILL |
HOSPITECH RESPIRATION LTD. |
YORAM LEVY |
K131099 |
05/13/2013 |
AG MASS |
HOSPITECH RESPIRATION LTD. |
YORAM LEVY |
K122741 |
05/07/2013 |
HOVEROUND TEKNIQUE |
HOVEROUND CORP. |
ROBERT MUNCH |
K122707 |
05/07/2013 |
HOVERROUND TEKNIQUE |
HOVEROUND CORP. |
ROBERT MUNCH |
K130591 |
05/02/2013 |
SUPERA VERITAS |
IDEV TECHNOLOGIES, INC. |
DARLENE GARNER |
K130338 |
05/31/2013 |
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS |
IMPEDIMED LIMITED |
John j Smith, M.D., J.D. |
K123551 |
05/14/2013 |
ITCLAMP 50 |
INNOVATIVE TRAUMA CARE INC |
RICHARD WAITE |
K130605 |
05/02/2013 |
INOMAX DSIR (DELIVERY SYSTEM) |
INO THERAPEUTICS |
ROBERT BOVY |
K122923 |
05/07/2013 |
QUANTA FLASH ENA7 |
INOVA DIAGNOSTICS, INC. |
MICHAEL MAHLER |
K130506 |
05/13/2013 |
IMSE P-TLIF |
INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION |
JOHN MORAN |
K122804 |
05/20/2013 |
ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM |
INTAI TECHNOLOGY CORP. |
KEVIN WANG |
K123428 |
05/20/2013 |
MIROCAM CAPSULE ENDOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
STEVE KWON |
K123022 |
05/17/2013 |
NEODENT IMPLANT SYSTEM |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
Allison C Komiyama |
K123662 |
05/22/2013 |
THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM |
JUSTRIGHT SURGICAL, LLC |
MICHELE LUCEY |
K130699 |
05/30/2013 |
ALEUTIAN SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
K131030 |
05/09/2013 |
RANGE SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
K130330 |
05/02/2013 |
RANGE SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
K122877 |
05/08/2013 |
RANGE SPINAL SYSTEM, SMALL STATURE |
K2M, INC. |
NANCY GIEZEN |
K120590 |
05/07/2013 |
DILATOR TUBE SET |
KOROS USA, INC. |
GABRIEL KOROS |
K131156 |
05/24/2013 |
LANX SPINAL FIXATION SYSTEM |
LANX, INC. |
MICHAEL MEDINA |
K123600 |
05/03/2013 |
DIGITAL BLOOD PRESSURE MONITOR |
LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. |
SELINA QIAN |
K123800 |
05/15/2013 |
WRIST AUTOMATIC BLOOD PRESSURE MONITOR |
LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. |
SELINA QIAN |
K123629 |
05/13/2013 |
FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES |
LUCENXIA PRESCIENCE AG |
ROBERT HILL |
K130189 |
05/21/2013 |
XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
LUBNA SYED |
K130639 |
05/16/2013 |
ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
K130513 |
05/08/2013 |
VOLISTA 400; VOLISTA 600 |
MAQUET SAS |
TOSIN YEDESS |
K121203 |
05/10/2013 |
BOSTON KERATOPROSTHESIS OR BOSTON KPRO |
MASSACHUSETTS EYE & EAR INFIRMARY |
BRIAN J EDWARDS |
K121243 |
05/03/2013 |
ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER |
MEDA CO. LTD. |
KAI CHEN |
K124034 |
05/17/2013 |
MECTALIF ANTERIOR |
MEDACTA INTERNATIONAL |
ADAM GROSS |
K123586 |
05/15/2013 |
EASYRA CREATININE REAGENT |
MEDICA CORPORATION |
Photios Makris |
K123617 |
05/15/2013 |
3F PRO-PICC |
MEDICAL COMPONENTS INC |
JESSICA LEO |
K130377 |
05/17/2013 |
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM |
MEDICATECH USA |
DANIEL KAMM, P.E. |
K123095 |
05/08/2013 |
MEDLINE BLOOD PRESSURE TRANSDUCER |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
K130319 |
05/31/2013 |
MEDLINE CANNULATED SCREW |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
K123619 |
05/24/2013 |
INTRABLOCK BIOBALL HIP SYSTEM (IBS) |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
K130547 |
05/31/2013 |
ENDOFORM RECONSTRUCTIVE TEMPLATE |
MESYNTHE LTD |
RONALD WARREN |
K123926 |
05/03/2013 |
METASURG NITINOL STAPLE IMPLANT |
METASURG |
JOSHUA SCOTT |
K122013 |
05/13/2013 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
K124056 |
05/29/2013 |
FREND PSA PLUS (REAGENT CARTRIDGE) |
NANOEN TEK, INC. |
JUDITH E LOEBEL |
K130346 |
05/02/2013 |
SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION |
NATUS NEUROLOGY INCORPORATED |
SHANE T SAWALL |
K131038 |
05/09/2013 |
NMI PICC MAXIMAL BARRIER NURSING KITS |
NAVILYST MEDICAL, INC. |
MARION W GORDON |
K123082 |
05/16/2013 |
MOBILECT VIEWER |
NEPHOSITY, INC. |
MICHAEL PAN |
K122214 |
05/21/2013 |
TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) |
NIHON KOHDEN CORP. |
STEVE GEERDES |
K122347 |
05/01/2013 |
ELISIO-H AND ELISIO-M HEMODIALYZERS |
NIPRO MEDICAL CORPORATION |
CAROLYN GEORGE |
K122343 |
05/07/2013 |
PUREFLUX-H HEMODIALYZER |
NIPRO MEDICAL CORPORATION |
CAROLYN GEORGE |
K123306 |
05/20/2013 |
NORDIC TUMOREX |
NORDICNEUROLAB |
CHANDANA G BHANDARI |
K122777 |
05/15/2013 |
NBX - NON BRIDGING EXTERNAL FIXATOR HAND |
NUTEK ORTHOPAEDICS, INC. |
PETER MINCIELI |
K121404 |
05/03/2013 |
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM |
ONSET MEDICAL CORPORATION |
JOSEPH BISHOP |
K123930 |
05/15/2013 |
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
K130332 |
05/31/2013 |
VITROS CHEMISTRY PRODUCTS TRIG SLIDES |
Ortho-Clinical Diagnostics, Inc. |
GAOZHEN HANG |
K121702 |
05/06/2013 |
ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE |
ORTHOCOR MEDICAL |
DAVID ROTHKOPF |
K130825 |
05/07/2013 |
AZURE ANTERIOR CERVICAL PLATE SYSTEM |
ORTHOFIX, INC. |
ALLY BADUEL |
K131324 |
05/31/2013 |
MAXTORQUE SCREW SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
BRIAN HOCKETT |
K130655 |
05/08/2013 |
RESPONSE SPINE SYSTEM |
ORTHOPEDIATRICS, CORP. |
MARK FOX |
K122124 |
05/16/2013 |
PORTABLE X-RAY SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
K130174 |
05/02/2013 |
DVTCARE CA5 |
OSSUR AMERICAS INC |
JOHN LINDAHL |
K130412 |
05/31/2013 |
OSTEOMED EXTREMIFUSE SYSTEM |
OSTEOMED |
PIEDAD PENA |
K130297 |
05/29/2013 |
SCANORA 3DX |
PALODEX GROUP OY |
MATTI TULIKOURA |
K130250 |
05/03/2013 |
QYAG LASER SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
NICOLE BROWN |
K130159 |
05/13/2013 |
QLAB QUANTIFICATION SOFTWARE HEART MODEL |
PHILIPS HEALTHCARE |
PENNY GRECO |
K130842 |
05/21/2013 |
ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
JOS VAN VROONHOVEN |
K130278 |
05/29/2013 |
MR PERMEABILITY |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
SUSAN QUICK |
K122500 |
05/03/2013 |
NEO PS KNEE SYSTEM |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
K123692 |
05/24/2013 |
PIPELINE KNEE SYSTEM |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
K121065 |
05/24/2013 |
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE |
POLYMED THERAPEUTICS, INC |
JJ XIA |
K130924 |
05/16/2013 |
BRUXZIR SHADED |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
K122700 |
05/31/2013 |
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES |
PROSBEN, INC. |
JEN KE-MIN |
K131009 |
05/07/2013 |
PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) |
PROTEUS DIGITAL HEALTH, INC. |
JAFAR SHENASA |
K122801 |
05/24/2013 |
PROVIDENCE CERVICAL CAGE |
PROVIDENCE MEDICAL TECHNOLOGY, INC. |
EDWARD LIOU |
K130811 |
05/02/2013 |
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE |
PSYCHEMEDICS CORP. |
VIRGINIA HILL |
K122663 |
05/30/2013 |
ORAMOIST |
QUANTUM, INC. |
FRED MA |
K121898 |
05/24/2013 |
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE |
QUICK-MED TECHNOLOGIES, INC. |
MARY MCNAMARA-CULLINANE |
K123748 |
05/07/2013 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
SOREN BOGESTRAND |
K130617 |
05/10/2013 |
RAYSTATION |
RAYSEARCH LABORATORIES AB |
DAVID HEDFORS |
K130282 |
05/13/2013 |
REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT |
REMINGTON MEDICAL, INC. |
CAITLIN SENTER, MS, RAC |
K122404 |
05/06/2013 |
MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 |
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS |
ANDREW I SEALFON |
K130457 |
05/20/2013 |
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL |
RESONANCE INNOVATIONS LLC |
RANDALL JONES |
K130170 |
05/29/2013 |
EXSPIRON 1XI |
RESPIRATORY MOTION, INC. |
JENNY FREEMAN, MD |
K130077 |
05/21/2013 |
REMSTAR SE |
RESPIRONICS, INC. |
FRANK KADI |
K130287 |
05/30/2013 |
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES M MEWBORNE |
K113539 |
05/03/2013 |
REVOIS PRO IMPLANT STSYEM |
RIEMSER ARZNEIMITTEL AG |
CHRISTOPH WAHL |
K123726 |
05/21/2013 |
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 |
Roche Diagnostics |
DAVID TRIBBETT |
DEN130002 |
05/23/2013 |
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM |
Roche Diagnostics |
Susan Hollandbeck |
K122785 |
05/14/2013 |
HYDROSIL; MAGIC; PERSONAL CATHETER |
ROCHESTER MEDICAL CORP. |
ROB ANGLIN |
K130632 |
05/03/2013 |
STERISPINE PS PEDICLE SCREW |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
K122774 |
05/09/2013 |
SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG |
SAKURA SEIKI CO., LTD. |
MARIA GRIFFIN |
K130734 |
05/15/2013 |
SAUFLON MULTIPURPOSE SOLUTION |
SAUFLON PHARMACEUTICALS, LTD. |
CHRISTOPHER SMEJKAL |
K130763 |
05/08/2013 |
BEACON TISSUE MARKER |
SCION MEDICAL TECHNOLOGIES LLC |
JOSEPH OSTENDORF |
K130830 |
05/09/2013 |
INTEGRA LAMINOPLASTY SYSTEM |
SEASPINE, INC. |
JEFF BRITTAN |
K122388 |
05/02/2013 |
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 |
SECA GMBH & CO. KG |
SETH A MAILHOT |
K123985 |
05/14/2013 |
SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 |
SENSUS HEALTHCARE |
KAL FISHMAN |
K123801 |
05/28/2013 |
FINGER PULSE OXIMETER |
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD |
Diana Hong |
K122614 |
05/16/2013 |
VINTAGE MP PRESS OVER |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
K122644 |
05/16/2013 |
ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
K130885 |
05/17/2013 |
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
K123510 |
05/17/2013 |
MAGNETOM SKYRA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
K130147 |
05/03/2013 |
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) |
SMALL BONE INNOVATIONS, INC. |
JOHN MINIER |
K130479 |
05/14/2013 |
ILIZAROV DRILL TIP WIRES |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K123159 |
05/03/2013 |
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS |
SMITH & NEPHEW, INC. |
MARTIN OSTMANN |
K123684 |
05/08/2013 |
SOL-CARE SAFETY NEEDLE |
SOL-MILLENNIUM MEDICAL |
JIM BARLEY |
K123855 |
05/24/2013 |
WATER-FILLED TEETHER |
SOLID TOYS IND. LTD. |
PAUL DRYDEN |
K124051 |
05/17/2013 |
THE VAULT SYSTEM |
SOMERSAULT ORTHOPEDICS, INC. |
PAMELA M BUCKMAN |
K121401 |
05/01/2013 |
TENDER TOUCH |
SOMETECH CORPORATION |
KI HAN |
K130558 |
05/17/2013 |
SOMNODENT HERBST; CLASSIC, FLEX |
SOMNOMED INC. |
KATHRYN A JAYNE |
K131088 |
05/24/2013 |
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
K122735 |
05/21/2013 |
SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 |
SORIN GROUP USA INC. |
SCOTT LIGHT |
K123912 |
05/14/2013 |
KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET |
SPENCER FILLMORE |
CHRISTINA BERNSTEIN |
K130267 |
05/31/2013 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
K131216 |
05/30/2013 |
RAMPART O |
SPINEOLOGY, INC. |
BRYAN BECKER |
K123769 |
05/10/2013 |
ZX-I POWER ADD ON |
SPINERGY, INC. |
EDWARD A KROLL |
K130594 |
05/03/2013 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
DONNA R LUNAK |
K123478 |
05/10/2013 |
STINGRAY BIPOLAR FORCEPS |
STINGRAY SURGICAL PRODUCTS |
MARK MCBRINN |
K123486 |
05/03/2013 |
TRIATHLON TRITANIUM TIBIAL BASEPLATE |
Stryker |
AUDREY WITKO |
K130430 |
05/23/2013 |
IVAS 10MM AND 15MM BALLOON CATHETER |
STRYKER CORPORATION |
CHRISTINA MCKEE |
K130334 |
05/03/2013 |
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM) |
Stryker Trauma AG |
ESTELA CELI |
K131132 |
05/31/2013 |
PELVIS II IMPLANT SYSTEM |
Stryker Trauma AG |
Elijah Wreh |
K131224 |
05/16/2013 |
SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
KRISTEN STOWELL |
K130869 |
05/30/2013 |
TAKE 1 ADVANCE |
SYBRON DENTAL SPECIALTIES |
Wendy Garman |
K130451 |
05/17/2013 |
NEUROQ 3.6 |
SYNTERMED, INC. |
KENNETH VAN TRAIN |
K130146 |
05/20/2013 |
SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM |
SYNTHES (USA) LLC |
STACEY BONNELL |
K122639 |
05/24/2013 |
SYNTHES SYNCAGE EVOLUTION SPACER |
SYNTHES (USA) PRODUCTS LLC |
HEMAL MEHTA |
K124040 |
05/16/2013 |
FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
PINJUNG CHEN |
K130326 |
05/07/2013 |
TEPHAFLEX MELTBLOWN CONSTRUCT |
TEPHA, INC. |
MARY P LEGRAW |
K131209 |
05/24/2013 |
TERASON USMART3200T ULTRASOUND SYSTEM |
TERATECH CORP. |
BEN CHIAMPA |
K130084 |
05/03/2013 |
MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM |
TGM MEDICAL, INC. |
PRAKASH PAI |
K120749 |
05/17/2013 |
HUMAN IGG CSF KIT |
THE BINDING SITE GROUP LTD |
JILL CONSTANTINE |
K120750 |
05/17/2013 |
HUMAN IGM CSF KIT |
THE BINDING SITE GROUP LTD |
JILL CONSTANTINE |
K120901 |
05/30/2013 |
HUMAN IGA CSF KIT FOR USE ON SPAPLUS |
THE BINDING SITE GROUP, LTD. |
JILL CONSTANTINE |
K120756 |
05/13/2013 |
LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE |
THE LAGADO CORP. |
ELLEN BEUCLER |
K122417 |
05/17/2013 |
SCOPEVALET DISPOSABLE BIOPSY VALVE |
THE RUHOF CORP. |
KIMBERLY MCCOY |
K122064 |
05/07/2013 |
FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE |
Tianjin New Bay Bioresearch Co., Ltd. |
Roger De Bock |
K131027 |
05/30/2013 |
MEMORY PUMP MODEL Y4947 |
TOMY INTERNATIONAL |
BRIAN THOMAS |
K130289 |
05/10/2013 |
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA |
TOPCON CORP. |
MAUREEN O'CONNELL |
K123542 |
05/15/2013 |
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER |
TOPCON MEDICAL LASER SYSTEMS, INC |
PAMELA M BUCKMAN |
K130533 |
05/17/2013 |
SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS |
Tornier SAS |
SEVERINE BONNETON |
K122635 |
05/13/2013 |
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR |
TORNIER, INC. |
LAEL J PICKETT |
K123500 |
05/02/2013 |
AQUILION LB TRITON V4.91 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
K130964 |
05/08/2013 |
GRIDLOCK PLATING SYSTEM |
TRILLIANT SURGICAL LTD |
J.D. WEBB |
K123400 |
05/16/2013 |
AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE |
TRUDELL MEDICAL INTL. |
DARRYL FISCHER |
K130943 |
05/20/2013 |
AIGIS RX R PM/ AIGIS RX R ICD |
TYRX , INC. |
SUSAN OLINGER |
K130463 |
05/15/2013 |
UCP HOME DRUG SCREENING TEST; CARDS, CUPS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
K123034 |
05/28/2013 |
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED |
UNILENE S.A.C. |
Kevin Walls |
K123550 |
05/01/2013 |
UTF STEM, REDUCED |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
K130494 |
05/07/2013 |
UNITRON TINNITUS MASKER FEATURE |
UNITRON HEARING |
JIM REITER |
K130432 |
05/31/2013 |
PHT-6500, PHT-60CFO |
VATECH CO., LTD. |
DAVE KIM |
K130184 |
05/24/2013 |
ZENOLUX |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K131093 |
05/21/2013 |
ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN BORMANN |
K130984 |
05/24/2013 |
PROFEMUR RENAISSANCE CLASSIC HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
YUAN LI |
K123932 |
05/01/2013 |
ZYGAFIX SPINAL FACET SCREW SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
K130899 |
05/01/2013 |
BIOLOX DELTA CERAMIC FEMORAL HEADS |
ZIMMER GMBH |
REBECCA M BROOKS |
K130661 |
05/09/2013 |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |