Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SOVIS OPTIQUE'S ENDOSCOPIC CABLE (K023633)Sovis Optique2002-12-31
PROFILE 1320 LASER SYSTEM (K022466)Sciton, Inc2002-12-31
NIGHTRON POLYSOMNOGRAPHY SYSTEM (K022249)Telediagnostic Systems, Inc.2002-12-31
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 (K023334)Baylis Medical Co., Inc.2002-12-31
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 (K024084)Abbott Laboratories2002-12-31
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY (K024032)Medtronic Vascular2002-12-30
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE (K024130)Wrp Asia Pacific Sdn. Bhd.2002-12-30
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY (K024035)Medtronic Vascular2002-12-30
BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES (K022091)Tangshan Zhonghong Pulin Group Co., Ltd.2002-12-30
6.0 X 5.7MM DENTAL IMPLANT (K010185)Bicon, Inc.2002-12-30
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (K022584)Cardiotech Intl.2002-12-30
PREPARE ADMINISTRATION SET (K023769)Appro Healthcare, Inc.2002-12-30
BD ULTRA-FINE III PEN NEEDLE (K024109)Becton, Dickinson & CO2002-12-30
ULTRA-LITE 200E LIGHT CURE UNIT (K023545)Rolence Ent., Inc.2002-12-30
MODIFICATION TO CARDEON AEGIS CATHETER (K024058)Cardeon Corp.2002-12-30
NARROW ASCENT INTERLOK FEMORAL COMPONENTS (K024037)Biomet, Inc.2002-12-30
SICKLE-CHEX SOLUBILITY KIT (K023656)Streck Laboratories, Inc.2002-12-30
3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS (K022009)Implant Innovations, Inc.2002-12-30
ACELL UBM HYDRATED WOUND DRESSING (K022854)Acell, Inc.2002-12-30
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) (K020020)Well-Life Healthcare, Inc.2002-12-30
GALAXY SERIES WHEELCHAIR (K023993)Evermed Corp.2002-12-27
PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY (K021987)S&S Par Scientific2002-12-27
NON-BIOABSORBABLE STAPLE (K023372)Onux Medical, Inc.2002-12-27
MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM (K023388)Mitek Worldwide2002-12-27
KEGELMASTER 2000 (K023305)Kegelmaster 2000 , Ltd.2002-12-26
MODIFICATION TO ALKP (K023807)Abbott Laboratories2002-12-26
ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 (K023222)Invitrocare, Inc.2002-12-26
MASTEL 1 FOLDER IMPLANTATION SYSTEM (K022723)Mastel Precision, Inc.2002-12-26
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 (K023259)Helix Medical, Inc.2002-12-26
AMMONIA ASSAY FOR THE ADVIA 1650 (K023841)Bayer Diagnostics Corp.2002-12-24
SCOUT BOSS (K023961)Burke, Inc.2002-12-24
USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY (K022517)U-Systems, Inc.2002-12-24
FEMOSTOP FEMORAL COMPRESSION SYSTEM (K024107)Radi Medical Systems AB2002-12-24
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 (K023962)New Star Lasers, Inc.2002-12-24
QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 (K023731)Consolidated Technology2002-12-24
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML) (K023634)Becton, Dickinson & CO2002-12-24
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER (K023784)Hemagen Diagnostics, Inc.2002-12-24
TELEGRAPH HUMERAL NAIL (K023241)Fournitures Hospitalieres Industrie2002-12-24
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 (K021509)Hygia Health Services, Inc.2002-12-24
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE (K023667)Plus Orthopedics2002-12-24
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) (K023349)Contamac, Ltd.2002-12-24
CHEETAH I.V.D.S., MODEL 2002P (K023370)Cheetah Medical, Inc.2002-12-24
AIA-PACK CA 19-9 (K023239)Tosoh Corp.2002-12-23
CHAMPION 5000 PERIPHERAL VASCULAR COIL (K023247)Usa Instruments, Inc.2002-12-23
RUSCH MICROLARYNGEAL TUBE (K023964)Rusch Intl.2002-12-23
AIM-V (R) MEDIUM, MODEL 087-0112 (K022086)Invitrogen Corporation2002-12-23
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) (K023396)Pointe Scientific, Inc.,2002-12-23
PAROS CRP (K022690)Horiba, Ltd.2002-12-23
MP-1 MICRO PERIMETER (K023719)Nidek Technologies Srl2002-12-23
Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN (K023877)Philips Ultrasound, Inc.2002-12-23
LTFS230 (K021775)Healthtronics, Inc.2002-12-23
AMALGA PACS (K023246)Global Care Solutions, S.A.2002-12-23
IMAGETILE (K023339)Barco N.V.2002-12-23
MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 (K023293)Med-Tec,Inc.2002-12-23
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML (K023527)Becton, Dickinson & CO2002-12-23
CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023340)Barco N.V.2002-12-23
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS (K023269)Instrumentation Laboratory CO2002-12-23
DISPOSABLE ASPIRATION NEEDLE NA-200H (K023272)The Olympus Optical Co.2002-12-23
CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023341)Barco N.V.2002-12-23
CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023322)Barco N.V.2002-12-23
ST AIA-PACK CA 19-9 (K023240)Tosoh Corp.2002-12-23
DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE (K022500)Rockwell Medical Technologies, Inc.2002-12-23
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES (K012691)Acutronic Medical Systems AG2002-12-20
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K023858)Becton, Dickinson & CO2002-12-20
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM (K024106)Siam Sempermed Corp., Ltd.2002-12-20
XTJF-160AF DUODENOVIDEOSCOPE (K024033)Olympus Optical Co., Ltd.2002-12-20
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO (K023883)I-Flow Corp.2002-12-20
STAT PROFILE PHOX PLUS L ANALYZER (K023567)Nova Biomedical Corp.2002-12-20
CANDELA GENTLE YAG LASER SYSTEM (K023193)Candela Corp.2002-12-20
MITEK PDS/PGA STAPLE (K021953)Mitek Worldwide2002-12-20
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES (K021826)Zimmer, Inc.2002-12-20
ACCESS TOTAL BHCG (K023480)Beckman Coulter, Inc.2002-12-20
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 (K023922)Coapt Systems, Inc.2002-12-20
TILITE EVO (K024055)Tisport, LLC2002-12-20
SYDNEY IVF HYALURONIDASE (K023353)Cook Urological, Inc.2002-12-20
FLEXIMA BILIARY CATHETER (K023870)Boston Scientific/Medi-Tech2002-12-20
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM (K024121)Siam Sempermed Corp., Ltd.2002-12-20
VOYAGER LINUX (K023975)Z-Kat, Inc.2002-12-20
GYNEFLEX (K021115)Naissance Holdings, LC2002-12-20
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE (K023554)Ge Lunar Corp.2002-12-20
SPECTRAPULSE (K022607)Primary Technology, LLC2002-12-20
COOPERSURGICAL MALLEABLE SYTLET (K023382)Cooper Surgical2002-12-20
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 (K024036)Johari Digital Healthcare , Ltd.2002-12-20
VACUUM ASSISTED CLOSURE (K021500)Kinetic Concepts, Inc.2002-12-20
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES (K022914)Rhythmlink International, LLC2002-12-20
MODIFICATION TO NANMA VACUUM PUMP (K013113)Nanma Mfg Co., Ltd.2002-12-20
VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 (K023154)Vascular Control Systems, Inc.2002-12-20
MODIFICATION TO MEDIPRIME (K023936)Algotec Systems, Ltd.2002-12-20
DENTA PORT (K022147)J. Morita USA, Inc.2002-12-20
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM (K024060)Howmedica Osteonics Corp.2002-12-20
DRX5000 (K023160)Axiom Usa., Inc.2002-12-20
SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES (K024011)Surgical Instruments Service and Savings, Inc.2002-12-19
PHILIPS EASYVISION WORKSTATION RELEASE 6 (K023137)Philips Medical Systems North America Co.2002-12-19
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER (K023862)Synthes (Usa)2002-12-19
REFLECTION CONSTRAINED LINER (K021803)Smith & Nephew, Inc.2002-12-19
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (K022660)Biocheck, Inc.2002-12-19
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA (K023669)Medical Analysis Systems, Inc.2002-12-19
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY (K024098)Roche Diagnostics Corp.2002-12-19
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE (K022715)ETHICON, Inc.2002-12-19
BIOPSY SITE TISSUE MARKER DEVICE (K023450)Promex, Inc.2002-12-19
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Every clearance here is in the API, with alerts when new ones post.