Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MEDI-DX 7000 CPT WITH AMREX ELECTRODES (K980866)Neuro-Diagnostic Assoc.1998-05-20
PHOTODERM HR SYSTEM (K974536)Esc Medical Systems , Ltd.1998-05-20
TIBC (K981279)Abbott Laboratories1998-05-20
SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES (K973615)Macro Rubber Industrial, Inc.1998-05-20
MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS (K980685)Lumenis, Inc.1998-05-20
OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER (K981407)Cordis Corp.1998-05-20
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS (K980665)Biomet, Inc.1998-05-20
FIBER OPTIC ENDOILLUMINATION PROBE (K980636)Dutch Ophthalmic USA, Inc.1998-05-20
PINPOINT (K974513)Philips Medical Systems (Cleveland), Inc.1998-05-20
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS (K981045)Exmoor Plastics , Ltd.1998-05-20
CUB DIS II DPOAE MEASUREMENT SYSTEM (K981460)Mimosa Acoustics, Inc.1998-05-20
SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) (K980880)Ansell Perry1998-05-20
ALKALINE PHOSPHATASE (ALKP) (K981245)Abbott Laboratories1998-05-20
OMEGA HA COATED TOTAL HIP SYSTEM (K980981)Osteoimplant Technology, Inc.1998-05-20
DUREX ULTRA COMFORT (K980319)London Intl., LLC1998-05-20
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 (K981458)Karl Storz Endoscopy1998-05-20
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS (K980837)Shimadzu Medical Systems1998-05-20
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER (K972595)Avid N.I.T., Inc.1998-05-20
RCI FIXATION SCREWS (K980841)Smith & Nephew, Inc.1998-05-20
PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 (K980656)Baxter Healthcare Corp1998-05-19
PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR (K980797)Peregrine Surgical , Ltd.1998-05-19
CRISTOBAL (K980018)Newave Medical, Inc.1998-05-19
RONDEX CPR ISO-SHIELD (K981169)Rondex Products, Inc.1998-05-19
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG) (K980625)Siemens Medical Solutions USA, Inc.1998-05-19
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 (K980658)Baxter Healthcare Corp1998-05-19
OPHTHAVISION IMAGING SYSTEM (K980295)Mrp Group, Inc.1998-05-19
SOVEREIGN CATARACT EXTRACTION SYSTEM (K981116)Allergan, Inc.1998-05-19
CATARACT LIQUEFRACTURE DEVICE (K980292)Alcon Laboratories1998-05-19
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES (K980604)Smith & Nephew, Inc.1998-05-19
NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC (K973789)Norian Corp.1998-05-18
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS (K981401)Boehringer Mannheim Corp.1998-05-18
CRYPTOSPORIDIUM TEST (K980354)Techlab, Inc.1998-05-18
ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM (K981020)Zeus Scientific, Inc.1998-05-18
RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE) (K973892)Rusch Intl.1998-05-18
CA (K981232)Abbott Mfg., Inc.1998-05-18
ATLASPLAN (K980584)Radionics, Inc.1998-05-18
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM (K981085)Gambro Healthcare1998-05-18
ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL (K974015)Davis & Geck, Inc.1998-05-18
PROWESS PRO-SIM (K980379)Ssgi Prowess Systems1998-05-18
LD-1 (K981338)Abbott Laboratories1998-05-18
CRITIKON SOFT BLOOD PRESSURE CUFF (K974080)Johnson & Johnson Medical, Inc.1998-05-18
OLYMPUS SONOSURG SYSTEM (K972114)The Olympus Optical Co.1998-05-18
ETEST GREPAFLOXACIN (K980773)Ab Biodisk1998-05-18
DEXON RAPID (DEXON R) (K980610)Davis & Geck, Inc.1998-05-18
VAPOCIDE (K970726)Cottrell, Ltd.1998-05-18
CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G (K980754)Crocker Industrial Resources Sdn. Bhd.1998-05-18
PASCO MIC AND MIC/ID PANELS (K980955)Pasco Laboratories, Inc.1998-05-18
MICRO-PLATE COTININE EIA (K974534)OraSure Technologies, Inc.1998-05-18
ORION WX DENTAL ALLOY (K981002)European Dental Imports, Inc.1998-05-18
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES (K981349)Smart Glove Corp. Sdn Bhd1998-05-18
SEGMENTAL DEFECT REPLACEMENT SYSTEM (K980609)Metagen, LLC1998-05-18
ORION VESTA DENTAL ALLOY (K981001)European Dental Imports, Inc.1998-05-18
SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES (K981348)Smart Glove Corp. Sdn Bhd1998-05-18
SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (K981347)Smart Glove Corp. Sdn Bhd1998-05-18
THE SYSTEM 2S STEAM STERILIZER (K980014)STERIS Corporation1998-05-15
Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT (K980793)Rolence Enterprise Co. , Ltd.1998-05-15
SITESEER ANGIOGRAPHIC CATHETER (K980575)C.R. Bard, Inc.1998-05-15
MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK (K981073)Medcom Laundry Service, Inc.1998-05-15
COVERTIP SAFETY SYRINGE (K971077)Medisys Technologies, Inc.1998-05-15
DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM (K980620)Dentatus USA , Ltd.1998-05-15
CU-100A LIGHT CURE UNIT (K980792)Rolence Enterprise Co. , Ltd.1998-05-15
3M CDI QUICK-CELLS WITH HEPARIN TREATMENT (K980732)3M Healthcare1998-05-15
CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN (K981000)European Dental Imports, Inc.1998-05-15
VARIOUS SURGICAL OR PATIENT DRAPES (K980210)Gel-Lite, LLC1998-05-15
LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES (K981179)Lovytex Sdn Bhd1998-05-15
EYE IRRIGATOR MODEL #2020 (K980647)Eye-Deal Ocular Safety Products, Inc.1998-05-15
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS (K981239)Deroyal Surgical1998-05-14
MICRO-PLATE COTININE EIA (K974234)OraSure Technologies, Inc.1998-05-14
BARD ISOFLOW BLOOD PUMP (K971421)C.R. Bard, Inc.1998-05-14
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS (K974584)Fresenius USA, Inc.1998-05-14
CAPIOX SX HARDSHELL RESERVOIR (K980935)Terumo Medical Corp.1998-05-14
STARDUST (K973920)Respironics, Inc.1998-05-14
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS (K980649)CooperVision, Inc.1998-05-13
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS (K981413)Boston Scientific Scimed, Inc.1998-05-13
SOFTLIGHT Q-SWITCHED (ND:YAG) LASER (K971207)Thermolase Corp.1998-05-13
PFLEIDERER'S INTRATYMPANIC CATHETER (K974008)Exmoor Plastics , Ltd.1998-05-13
GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE (K971374)Wilson Greatbatch Technologies, Inc.1998-05-13
DURA-PATCH MODEL DP-XXX (K980548)Bridger Biomed, Inc.1998-05-13
THIRD GENERATION PSA CONTROL MODULE (K981455)Diagnostic Products Corp.1998-05-13
ETEST TROVAFLOXACIN (K980603)Ab Biodisk1998-05-13
NIDEK PRIMA MODEL GYC-1500/2000 (K980547)Nidek, Inc.1998-05-13
ACCU-CHEK A1C HEMOGLOBIN TEST (K974491)Boehringer Mannheim Corp.1998-05-13
SERAQUEST ANTI-SSA (K980810)Quest Intl., Inc.1998-05-12
LYPHOCHEK IMMUNOASSAY PLUS CONTROL (K981532)Bio-Rad1998-05-12
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. (K981059)Diagnostic Chemicals , Ltd.1998-05-12
ULTRA-BLASTER (K980726)Ultradent Products, Inc.1998-05-12
CO2 (K981231)Abbott Mfg., Inc.1998-05-12
COLOSCREEN-ES (K980671)Helena Laboratories1998-05-12
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS (K981426)Nova Biomedical Corp.1998-05-12
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS (K981425)Nova Biomedical Corp.1998-05-12
USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE (K973820)Circon Corp.1998-05-12
STAT PROFILE M ANALYZER (K981427)Nova Biomedical Corp.1998-05-12
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) (K971408)Ikonos Corp.1998-05-12
PREMIER PLATINUM HPSA (K980076)Meridian Diagnostics, Inc.1998-05-12
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE (K980857)Graphic Controls Corp.1998-05-12
HEMOCOR HPH MINI HEMOCONCENTRATOR (K980859)Minntech Corp.1998-05-12
ARCHIMED 4210 AND 4220 (K973922)Biosound Esaote, Inc.1998-05-12
PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 (K980530)Peregrine Surgical , Ltd.1998-05-12
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM (K980337)Helix Diagnostics, Inc.1998-05-12
MEGAVAC SYSTEM (K974196)Barry J. Kaplan, Inc.1998-05-12
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Every clearance here is in the API, with alerts when new ones post.