Atlas FDA

1993

4,167 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER (K925991)Convatec, A Division of E.R. Squibb & Sons1993-10-28
DUODERM HYDROACTIVE DRESSING (K925993)Convatec, A Division of E.R. Squibb & Sons1993-10-28
VENTI-GENTLE-HALER(TM) (K933915)Vortran Medical Technology 1, Inc.1993-10-28
PHILIPS MRI BREAST COIL (K926275)Philips Medical Systems, Inc.1993-10-28
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 (K932660)More Diagnostics1993-10-28
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC (K932912)Baxter Diagnostics, Inc.1993-10-28
LUMINOUS 150 FIBEROPTIC ILLUMINATOR (K933593)Progressive Dynamics, Inc.1993-10-28
GENZYME A-AMYLASE TEST REAGENT (K933397)Genzyme Corp.1993-10-28
BECKMAN CHOLESTEROL REAGENT (K934046)Beckman-Diagnostic Systems Group1993-10-28
SYNERMED DIRECT BILIRUBIN REAGENT KIT (K933026)Synermed, Inc.1993-10-28
CARDIO REP RECOMBINANT CK ABNORMAL CONTROL (K932442)Helena Laboratories1993-10-28
DUODERM EXTRA THIN CGF DRESSING (K925990)Convatec, A Division of E.R. Squibb & Sons1993-10-28
DMA AMYLASE PROCEDURE (K931559)Data Medical Associates, Inc.1993-10-28
HOBBS MEDICAL CLEANING BRUSH (K933354)Hobbs Medical, Inc.1993-10-28
REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK (K933657)Remel Co.1993-10-28
ISI(R) HOOK SUTURES SCISSORS (K932698)Innovative Surgical, Inc.1993-10-27
MOBILE CARE IV STAND (K932498)Mobile Care, Inc.1993-10-27
AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY (K924698)Orthomet, Inc.1993-10-27
BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM (K933319)Birtcher Medical Systems, Inc.1993-10-27
SURGICAL SUCTION TIP (K932185)Tlc Medservices, Inc.1993-10-27
EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR (K921114)Exactech, Inc.1993-10-27
STAGO FACTOR XI-DEFICIENT PLASMA (K933444)American Bioproducts Co.1993-10-27
BOOTY ENDOSCOPE WARMER (K933515)T-Med, Inc.1993-10-27
AVITENE DISPENSER SYRINGE (K924517)Nusurg, Inc.1993-10-27
STAGO FACTOR X-DEFICIENT PLASMA (K933441)American Bioproducts Co.1993-10-27
BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (K930302)Birtcher Medical Systems, Inc.1993-10-27
BONE SCREWS (K923841)Instrument Makar, Inc.1993-10-27
STAR BREATHING CIRCUITS (K934753)Infrasonics Corp.1993-10-27
STAGO FACTOR XII-DEFICIENT PLASMA (K933438)American Bioproducts Co.1993-10-27
STAGO FACTOR VII-DEFICIENT PLASMA (K933440)American Bioproducts Co.1993-10-27
ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR (K925328)Anspach Mfg., Inc.1993-10-27
BARD PTFE VASCULAR GRAFT (K933204)C.R. Bard, Inc.1993-10-27
COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE (K923290)A Mixed Bag Corp.1993-10-27
THE DE SOUTTER M182 DRILL (K930785)De Soutter Medical, Ltd.1993-10-27
CAPNODIG (K933707)Spegas Industries, Ltd.1993-10-27
BECKMAN CX AMMONIA/ALCOHOL CONTROL (K934467)Beckman-Diagnostic Systems Group1993-10-27
ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS (K934172)Acro-Poly, Inc.1993-10-27
EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM (K921113)Exactech, Inc.1993-10-27
THE DE SOUTTER M193 REAMER (K930784)De Soutter Medical, Ltd.1993-10-27
OTT INSUFFLATION FILTER TUBING (K920205)Georgia Biomedical Research Group, Inc.1993-10-25
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR (K931542)Newport Medical Instruments, Inc.1993-10-25
CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY (K926252)Endosonics Corp.1993-10-25
FLYNNR GENESIS II A/C, A/O AND IDLH (K932170)O-Two Systems Intl., Inc.1993-10-25
STABILTUBE (K934117)Garrett Medical Products1993-10-25
AIRCAST VENAFLOW SYSTEM (K932900)Aircast, Inc.1993-10-25
PATHROMTIN (K932011)Behring Diagnostics, Inc.1993-10-25
SAFESET RESERVOIR (K932188)Abbott Laboratories1993-10-25
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES (K932344)Siemens Medical Solutions USA, Inc.1993-10-25
MODEL 9100 H.R. INFANT SCALE (K926174)Acme Medical Scale Co.1993-10-25
AVI MODEL 600 SYRINGE PUMP (K933005)3M Health Care, Ltd.1993-10-25
STERI-CATH MDI (K923559)Concord/Portex1993-10-25
POWDER-FREE LATEX PATIENT EXAMINATION GLOVES (K931633)Tomarc (M) Sdn Bhd1993-10-25
AVI INFUSION PUMPS, ADDITIONAL INTENDED USE (K933006)3M Health Care, Ltd.1993-10-25
FLEX-TECH BALLOON DILATOR (K926038)Cape Tech Medical Products1993-10-25
1500 SERIES REGULATOR (K932006)Precision Medical, Inc.1993-10-25
SIGMA ELECTROLYTE BUFFER (K933695)Sigma Chemical Co.1993-10-22
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY (K933464)Baxter Diagnostics, Inc.1993-10-22
EDENTEC MODEL 3710 I DIGITAL PRINTER (K921819)Edentec Corp.1993-10-22
READAR (K930478)Alamar Biosciences, Inc.1993-10-22
CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING (K926299)Depuy, Inc.1993-10-22
VISTA FOLATE ASSAY (K934121)Syva Co.1993-10-22
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT (K933329)King Diagnostics, Inc.1993-10-22
AIA-PACK(R) PROG ASSAY (K933269)Tosoh Medics, Inc.1993-10-22
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE (K930950)W. L. Gore & Associates, Inc.1993-10-22
PROGESTERONE RADIOIMMUNOASSAY KIT (K931228)Immunotech Corp.1993-10-22
VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM (K920438)Via Medical Corp.1993-10-22
AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY (K930595)Orthomet, Inc.1993-10-22
MITEK LIGAMENT ANCHOR (K926270)Mitek Surgical Products, Inc.1993-10-22
MEDAC SYSTEM/3 (K914925)Davicon, Inc.1993-10-21
SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE (K931185)Optical Sensors, Inc.1993-10-21
ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD (K924388)Angemed, Inc.1993-10-21
KNOT PUSHER (K933243)Advanced Surgical, Inc.1993-10-21
MODEL EP-2 CLINICAL STIMULATOR (K933069)Ep Medical, Inc.1993-10-21
TSA 2001 THERMAL SENSORY ANALYZER (K922052)Medoc Corp.1993-10-21
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2 (K934357)Bio-Rad1993-10-21
POWDER-FREE PATIENT EXAMINATION GLOVES (K931406)P.T. Healthcare Glovindo1993-10-21
SURVALENT II ORAL THERMOMETER (K923289)Epson America, Inc.1993-10-21
PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER (K934509)Sdi Diagnostics, Inc.1993-10-21
GLENN BED (K931581)Kinetic Concepts, Inc.1993-10-21
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS (K923988)Sensor Medics Corp.1993-10-21
BRIMFIELD PRECISION SCISSOR (K933388)Springfield Surgical Instruments1993-10-21
KOKO FILTER II (K934475)Pulmonary Data Services Inst., Inc.1993-10-21
AUKUSLEEVE (K930094)Aukland Medical Plastics, Inc.1993-10-20
AMDENT 2030, POLISHER/SCALER (K920328)Amdent AB1993-10-20
A-DEC 2611 ASSISTANT'S CART (K933166)A-Dec, Inc.1993-10-20
PROFILE SERIES 29 FILES (K933582)Tulsa Dental Products, Ltd.1993-10-20
ORMCO SPORTSGUARD (K922806)Ormco Corp.1993-10-20
BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP. (K925767)Nobelpharma USA, Inc.1993-10-20
INTRA-ORAL IRRIGATOR (K933547)Parkell, Inc.1993-10-20
RESIMENT WITH FLUORIDE (K933459)J.L. Blosser, Inc.1993-10-20
VS 1A (K933563)Metalor Dental USA Corp.1993-10-20
SIGMA-BRILLEN (OR) MULTIPLE (K930956)Sigma-Brillen1993-10-20
DW232 #31 (K932774)Invoclar North America, Inc.1993-10-20
MODISSA 90 S.R.L. SUNGLASSES (K930858)Modissa 90 Srl1993-10-20
NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE (K933150)Nobelpharma USA, Inc.1993-10-20
EYEGLASSES FRAMES (K933529)Vistula Assistance & Consulting Bureau1993-10-20
BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER (K934540)Bird Life Design1993-10-19
E*NET NEUROMONITORING SYSTEM (K930080)Physiometrix, Inc.1993-10-19
HAN-D-AID (K924793)Salmon Ent.1993-10-19
OHMEDA MODEL 5330 ANESTHETIC MONITOR (K931439)Ohmeda Medical1993-10-19
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Track 1993 automatically

Every clearance here is in the API, with alerts when new ones post.