Atlas FDA

2002

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

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RecordFirmDate
VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE (K020576)Id Biomedical Corp.2002-05-01
SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES (K020053)Safe Shield Co., Ltd.2002-05-01
AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (K021217)Biotronik, Inc.2002-05-01
SOLO ORTHO 3 (K020502)Sybron Dental Specialties, Inc.2002-05-01
FRC POSTEC (K013802)Ivoclar Vivadent, Inc.2002-05-01
FIXATION (STEINMANN) PINS (K013888)Miltex, Inc.2002-05-01
OLYMPUS BF TYPE UM40 (K021204)Olympus Optical Co., Ltd.2002-05-01
KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS (K011859)Klimamed Technologie Medizingerate GmbH2002-05-01
GRIDLOCK 195 ADHESIVE (K020648)Allodex Systems2002-05-01
KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN (K012614)Medical Instruments Technology, Inc.2002-05-01
DIGI-PRO TENS MODEL WL-2203 AND WL-2205 (K021359)Well-Life Healthcare, Inc.2002-04-30
BCI 3180 PULSE OXIMETER (K020350)Bci, Inc.2002-04-30
DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 (K020314)Well-Life Healthcare, Inc.2002-04-30
GLOBAL ECG MANAGEMENT SYSTEM (GEMS) (K020366)Cardiocomm Solutions, Inc.2002-04-30
EAV KINDLING 2000S GSR DEVICE (K020564)Virbrant Health2002-04-30
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR (K020691)Dade Microscan, Inc.2002-04-30
PATTON TRIPOL (K012279)Patton Medical Corp.2002-04-30
AKUPORT M-2 (K020568)Vibrant Health2002-04-30
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE (K020686)Dade Microscan, Inc.2002-04-30
EAV COMBI-2 (K020565)Vibrant Health2002-04-30
GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED) (K020210)Bayer Group Diagnostics2002-04-30
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER (K013471)E.S.W.L. Products, Inc.2002-04-29
CLEARVIEW WRIST FIXATOR (K020311)Rigid FX Orthopedics, Incorporated2002-04-29
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL (K021155)Medical Analysis Systems, Inc.2002-04-29
EVANS SUB-Q, MODEL MC4206 (K020530)Evans Medical, Inc.2002-04-29
REPROCESSED GUIDEWIRES (K012556)Sterilmed, Inc.2002-04-29
GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) (K020208)Bayer Group Diagnostics2002-04-29
QUANTA LITE CCP ELISA (K020414)Inova Diagnostics, Inc.2002-04-29
CALIBRATING MATERIAL, CAL-PAK, BUFFERS (K020894)Mission Diagnostics2002-04-29
ETEST ERTAPENEM (K020748)Ab Biodisk2002-04-29
MID LABS AUTONOMOUS VIT ENHANCER (AVE) (K020911)Medical Instrument Development Laboratories, Inc.2002-04-29
BUSSE UMBILICAL CORD CLAMP CUTTER (K021055)Busse Hospital Disposables, Inc.2002-04-29
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN (K020626)Dade Microscan, Inc.2002-04-26
MALE LATEX CONDOM WITH RIBBED SURFACE (K020272)Pleasure Latex Products Sdn. Bhd.2002-04-26
FUSION 7D (K020546)Mirada Solutions , Ltd.2002-04-26
GC FUJI ORTHO BAND PASTE PAK (K020578)GC America, Inc.2002-04-26
CRYOPEN AND ACCESSORIES (K012214)Cimex Biotech, LLC2002-04-26
ACIST PLUS 4 ANGIOGRAPHIC CATHETER (K021015)Acist Medical Systems2002-04-26
SUPER EON PLUS FEMORAL STEMS (K020989)Howmedica Osteonics Corp.2002-04-26
MICROJET MODEL # CD4 AND CD4/20 (K013776)Cane S.R.I.2002-04-26
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN (K020556)Dade Microscan, Inc.2002-04-26
BACT/ALERT SN CULTURE BOTTLE (K021123)bioMerieux, Inc.2002-04-26
SIIS#1 TISSUE SUSPENSION SYSTEM (K020705)Tag Medical Products2002-04-26
SERRALSILK (K020901)Serral, S.A. DE C.V.2002-04-26
OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS (K020690)Ocu-Ease Optical Products, Inc.2002-04-26
SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16 (K021197)Hosuk Co., Ltd.2002-04-26
LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112 (K020307)Hakko Shoji Co., Ltd.2002-04-26
MICROJET CRONO (K013234)Cane S.R.L.2002-04-26
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR (K020392)CooperVision, Inc.2002-04-26
SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE (K021005)Sterling Medivations, Inc.2002-04-25
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 (K013517)Medtronic Vascular2002-04-25
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES (K020708)Philips Medical Systems, Inc.2002-04-25
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES (K014089)Sun Biomedical Laboratories, Inc.2002-04-25
S2 TIBIAL NAIL (K021027)Howmedica Osteonics Corp.2002-04-25
COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE (K010128)Cook Vascular, Inc.2002-04-25
ATRION MEDICAL QL FLUID DISPENSING SYRINGE (K020333)Atrion Medical Products, Inc.2002-04-25
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) (K014168)Biosound Esaote, Inc.2002-04-25
PVS BASIC 2; EPIC 2 (K013310)Paragon Vision Sciences2002-04-25
ISAAC 1.5 T MR SYSTEM (K020268)Chi, Inc.2002-04-25
S2 FEMORAL NAIL (K021026)Howmedica Osteonics Corp.2002-04-25
SIMPLICITY (K020570)Apex Dental Materials, Inc.2002-04-24
POLYMEDCO HBA1C TEST (K020532)Polymedco, Inc.2002-04-24
LYMPHA VISION-EXPERT (K003896)Bexley Trading, Inc.2002-04-24
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL (K020601)Odin Medical Technologies , Ltd.2002-04-24
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS (K020289)Machnet BV2002-04-24
AGC SPEZIALLEGIERUNG (K020347)Wieland Edelmetalle GmbH & Co.2002-04-24
JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA (K020515)Jostra AG2002-04-24
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY (K020954)Ackrad Laboratories2002-04-24
DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S (K020257)Datascope Corp.2002-04-24
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM (K021103)Zeus Scientific, Inc.2002-04-24
STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM (K012387)Stethographics, Inc.2002-04-23
ANNULOFLO SYSTEM, MITRAL MODEL AR700 (K021051)Sulzer Carbomedics, Inc.2002-04-23
DIASOL-BICARB (K020230)Diasol, Inc.2002-04-23
SYNTHES TRANSLATING MAXILLARY DISTRACTOR (K020505)Synthes (Usa)2002-04-23
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS) (K020300)Syntermed, Inc.2002-04-23
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 (K020604)Nellcor Puritan Bennett, Inc.2002-04-23
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL (K020495)Surgi-Vision, Inc.2002-04-23
ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K020838)Ar Alliance Healthcare Sdn. Bhd.2002-04-23
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE (K020589)3M Company2002-04-22
BIRD TBIRD VELA VENTILATOR (K020746)Bird Products Corp.2002-04-22
DISTAL RADIUS PLATING SYSTEM (K020819)Biomet, Inc.2002-04-22
SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) (K020244)Synthes Spine2002-04-22
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) (K020868)Seal Polymer Industries Bhd.2002-04-22
BOND-3 ADHESIVE (K020499)Jeneric/Pentron, Inc.2002-04-22
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS (K013905)Pro-Tech Services, Inc.2002-04-22
MOTION TRACKING (K020294)Accuray, Inc.2002-04-22
SONATA MICRO HYBRID COMPOSITE (K020555)Pentron Laboratory Technologies2002-04-22
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 (K020610)Bio-Rad2002-04-22
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER (K013865)Cook, Inc.2002-04-22
HOMMED CENTRAL STATION (K020184)Hommed, LLC2002-04-22
SNAP EEG MONITOR (K020218)Nicolet Biomedical, Inc.2002-04-22
THERMOMETER MODELS ST8631 (K021048)Z7 International2002-04-22
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML) (K020397)Dade Behring, Inc.2002-04-22
50S TRINGA ULTRASOUND IMAGING SYSTEM (K020112)Pie Medical2002-04-19
QAB2A IGG ELISA KIT (K020695)Cheshire Diagnostics , Ltd.2002-04-19
ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE (K020918)Eci Medical Technologies, Inc.2002-04-19
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS (K021213)Boston Scientific Corp2002-04-19
TEKNIQUE-HOVEROUND POWER WHEEL CHAIR (K021136)Hoveround Corp.2002-04-19
MODIFICATION TO FETAL ASSIST (K020390)Huntleigh Diagnostics , Ltd.2002-04-19
EMS ELECTROSTATIC FLITER AND HME COMBINATION (K013122)Engineered Medical Systems2002-04-19
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Every clearance here is in the API, with alerts when new ones post.