Atlas FDA

2003

3,516 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PORTABLE RO+ MODEL MROS09 (K030059)Ameriwater2003-04-07
PS 3000 DIGATAL PHOTOSPOT SYSTEM (K030061)Precise Optics2003-04-07
STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM (K023614)Case Medical, Inc.2003-04-07
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM (K030949)Sonosite,Inc.2003-04-07
SEED LINK (K023073)Implant Sciences Corp.2003-04-07
COZART EIA OPIATES ORAL FLUID KIT (K024339)Cozart Bioscience , Ltd.2003-04-07
DRIP ALERT (K030136)Drip Alert, Inc.2003-04-07
VERSABOARD, MODEL 7040 (K030051)Bionix Development Corp.2003-04-04
JI-EE ELECTRIC SCOOTER, ESTHETE ES 1 (K024325)Ji-Ee Industry Co., Ltd.2003-04-04
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR (K030245)Arista Latindo Industrial Ltd. P.T2003-04-04
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K030092)Advanced Medical Optics, Inc.2003-04-04
RADIONICS SINGLE USE GROUND PAD (DGP-HP) (K030697)Radionics, Inc.2003-04-04
ELFCARE DEVICE, MODELS 314A THROUGH 314G (K023231)Mediseb , Ltd.2003-04-04
SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS (K030858)Synthes (Usa)2003-04-04
FLEXIBLE TIP THERMOMETER, MODEL 011206 (K030673)Global Treasure Industries , Ltd.2003-04-04
SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K030548)St. shine Optical Co., Ltd.2003-04-04
FRONTIER MODEL X5 (K030783)Vestil Manufacturing Corp.2003-04-04
MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) (K030459)Alaris Medical Systems, Inc.2003-04-04
SWITCHBLADE (K030890)Snowden Pencer, Inc.2003-04-04
RABBIT MOBILE STANDING FRAME (K030882)R82 A/S2003-04-04
WU'S POWERED WHEELCHAIR, MAMBO 3 (K030707)Wu'S Tech Co., Ltd.2003-04-04
WU'S POWERED WHEELCHAIR, MAMBO 5 (K030709)Wu'S Tech Co., Ltd.2003-04-04
FIBERFILL AGP (K023818)Pentron Clinical Technologies2003-04-03
PRECISET DAT AMPHETAMINE (K030826)Quantimetrix Corp.2003-04-03
MICROCAP PLUS/NPB-75 (K024300)Oridion Medical 1987 , Ltd.2003-04-03
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 (K022112)Fortune Medical Instrument Corp.2003-04-03
STERRAD 50 & STERRAD 100S STERILIZERS (K023290)Advanced Sterilization Products2003-04-03
SMALL HIGH SPEED MOTOR DRILL SYSTEM (K030172)Brasseler USA I, L.P.2003-04-03
IVS INTRODUCER SET, MODEL 1003 (K030723)Integrated Vascular Systems, Inc.2003-04-03
ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0 (K030062)Avantec Vascular Corp.2003-04-03
GALEMED PEAK FLOW METER, MODELS 3751/3752 (K022124)Galemed Corp.2003-04-03
TUOHY EPIDURAL NEEDLE (K030562)Epimed International, Inc.2003-04-03
P2 POLYETHER (K030318)Heraeus Kulzer, Inc.2003-04-03
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR (K030110)Mick Radio-Nuclear Instruments, Inc.2003-04-03
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES (K030736)Medtronic Sofamor Danek2003-04-02
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE (K024350)ACON Laboratories, Inc.2003-04-02
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER (K030167)Clearlab Pte , Ltd.2003-04-02
HEMOCHRON RESPONSE/SYSTEM (K030818)International Technidyne Corp.2003-04-02
KSEA POWERSHAVER SYSTEM S2 (K030009)Karl Storz Endoscopy2003-04-02
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT (K030686)Exactech, Inc.2003-04-02
COBRA BIPOLAR CLAMP, MODEL 15902 (K023288)Boston Scientific EP Technologies2003-04-02
EVA EMPTY SOLUTION CONTAINER (K030888)Metrix Co.2003-04-02
COLONCARE (K030216)Care Products, Inc.2003-04-02
LEVO COMBI (K030893)Levo AG2003-04-02
MRI-CADDY (K030323)Mammendorfer Institute For Physics & Medicine GmbH2003-04-02
HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE (K030572)Henke Sass Wolf of America, Inc.2003-04-01
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 (K030153)Zimmer, Inc.2003-04-01
RITA CLIPS FOR INFUSION PUMPS (K030936)Rita Medical Systems, Inc.2003-04-01
SUPEROPEN 0.35T, MODEL NSM-P035 (K030918)Neusoft Digital Medical Systems Co., Ltd.2003-04-01
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K030094)Shanghai Palomar Mountain Industries, Inc.2003-04-01
HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (K021622)Hill-Rom Air-Shields2003-04-01
SELITHERM, MODEL C100 (K030382)Selicor, Inc.2003-04-01
CONSENSUS UNIPOLAR HEAD, COCR (K030205)Hayes Medical, Inc.2003-04-01
ODI 7.0MM CANNULATED SCREW SYSTEM (K030619)Orthopedic Designs, Inc.2003-04-01
OSTEOMED CRANIAL FLAP FIXATION SYSTEM (K022277)Osteomed Corp.2003-04-01
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE (K030390)Synthes (Usa)2003-04-01
CONSTRAINED LINER (K023794)Encore Medical L.P.2003-04-01
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE (K030677)Becton, Dickinson & CO2003-04-01
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM (K030740)Roche Diagnostics Corp.2003-04-01
GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% (K030027)Gelflex Laboratories2003-04-01
HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM (K030198)Hand Innovations, Inc.2003-04-01
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING (K023381)Gish Biomedical, Inc.2003-03-31
VBL SERUM TROPONIN I TEST, MODEL 1001 (K023505)Vancouver Biotech , Ltd.2003-03-31
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (K030721)Ballard Medical Products2003-03-31
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR (K030154)Dideco S.P.A.2003-03-31
JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 (K030053)Jomed AG2003-03-31
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM (K024371)Candela Corp.2003-03-31
ITI DENTAL IMPLANT SYSTEM (K030007)Straumann USA2003-03-31
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (K030616)Microgenics Corp.2003-03-31
SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS (K030653)Power Medical Interventions, Inc.2003-03-31
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (K024006)Pointe Scientific, Inc.,2003-03-31
GISH ARTERIAL FILTER WITH GBS COATING (K023833)Gish Biomedical, Inc.2003-03-31
ACCOUSONIC, MODEL AS-270 (K030878)Metron Medical Australia, Pty, Ltd.2003-03-28
ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX (K023257)Prosurg, Inc.2003-03-28
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE (K030351)Cp Medical2003-03-28
OXICHECK (K023565)Caradyne, Ltd.2003-03-28
ECHELON MICRO CATHETER, MODEL 105-5092-150 (K030688)Micro Therapeutics, Inc.2003-03-28
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C (K022446)Aomori Olympus Co., Ltd.2003-03-28
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE (K022965)Blackstone Medical, Inc.2003-03-28
SEEDLINKS, MODELS 70301, 70302, 70303 (K023210)Sourcetech Medical, LLC2003-03-28
POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE (K030386)Shamrock Manufacturing Company2003-03-28
LAWRENCE CSERION, MODEL CS-1 (K030162)Isoray, Inc.2003-03-28
VECTORSURGE 5 MODEL 470 (K030648)Metron Medical Australia, Pty, Ltd.2003-03-28
ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER (K030571)Ethicon Endo-Surgery, Inc.2003-03-28
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS (K023918)Rusch Intl.2003-03-28
POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM (K030325)Pt.Shamrock Manufacturing Corp.2003-03-28
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM (K030874)General Electric Co.2003-03-28
THE OBSIDIAN PACS SYSTEM (K030635)Obsidian Medical Technology, Inc.2003-03-28
TEOAE25 (K030016)Interacoustics A/S, Assens2003-03-28
EXPRESS BLOOD GLUCOSE MONITORING SYSTEM (K024347)Hypoguard USA, Inc.2003-03-28
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD (K030674)Advanced Neuromodulation Systems2003-03-28
ER800 SERIES ECG EVENT RECORDER (K030856)Braemar Corp.2003-03-28
VERMED A10021 RESTING EKG TAB ELECTRODE (K030073)Vermont Medical, Inc.2003-03-28
SPINAL CONCEPTS INC. PATHFINDER (K030625)Spinal Concepts, Inc.2003-03-28
MPM-NET (K030825)Aerotel Medical Systems (1998) , Ltd.2003-03-28
REPROCESSED PULSE OXIMETER SENSORS (K012677)Sterilmed, Inc.2003-03-28
QUANTA LITE H.PYLORI IGA ELISA (K024334)Inova Diagnostics, Inc.2003-03-27
EXEL BUTTERFLY SCALP VEIN SET (K020189)Exelint International, Co.2003-03-27
ORG@NIZER, MODEL VERSION 3.0 (K030363)Ebit Sanita, S.P.A.2003-03-27
MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE (K030212)Genzyme Biosurgery2003-03-27
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