Atlas FDA

1993

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

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RecordFirmDate
MOBILAIRE LIQUID OXYGEN SYSTEMS (K926267)Invacare Corp.1993-08-31
FRAMES, SPECTACLE (K932813)Rainbow Optics, Inc.1993-08-31
10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (K932762)Inman Medical Corp.1993-08-31
CYBILNATE(R) UMBILICAL CATHETER (K926097)Cyex Medical Technologies, Inc.1993-08-31
SIGMA 7000 AND SIGMA70002 (K926191)Sigma1993-08-31
MSP OPHTHALMIC (EYE SPUD) (K931449)Medical Sterile Products, Inc.1993-08-31
OLYMPUS REPLY GLUCOSE REAGENT (K931744)Olympus Corp.1993-08-31
SPECTACLE FRAMES (K932906)U.S. Optics, Inc.1993-08-31
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER (K926000)Boston Scientific Corp1993-08-30
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED (K933304)Depuy, Inc.1993-08-30
FUKUDA DENSHI MODEL UF-4500 (K922208)Fukuda Denshi USA, Inc.1993-08-30
PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST (K932921)B. Braun Vena-Tech1993-08-30
ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF (K933053)Roche Diagnostic Systems, Inc.1993-08-30
GM SWIVEL VIDEO (TM) IRRIGATOR (K931398)Gm Engineering, Inc.1993-08-30
MAGNETOM P8 (K932338)Siemens Medical Solutions USA, Inc.1993-08-30
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET (K925362)Baxter Healthcare Corp1993-08-28
IV PREP KIT (NON-STERILE) (K925017)Customed, Inc.1993-08-27
TRI-TECH INC. CUSTOM BLOOD ALCOHOL (K922342)Tri-Tech, Inc.1993-08-27
N-PAC (K924055)National Healthcare Linen Service1993-08-27
PROCEDURE KIT (K926269)General Medical Co.1993-08-27
I.V. START KIT (AHC-50-54954 (K924192)American Healthcare Corp.1993-08-27
DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA (K932249)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-08-27
DRESSING CHANGE TRAY-MODIFIED (K931932)Medsurg Industries, Inc.1993-08-27
MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY (K930539)Medical Components, Inc.1993-08-27
TRACHEOSTOMY KIT (K925288)Ajs Medical Co., Inc.1993-08-27
FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT (K924697)Abbott Laboratories1993-08-27
CARDIAC CATH OR ANGIOGRAPHIC TRAYS (K932218)Associated Medical Products Co.1993-08-27
PERCUTANEOUS TRACHEOSTOMY TUBE KIT (K931611)Crandall Medical Devices1993-08-27
IV PREP KIT W/O DRESSING (NON-STERILE) (K925018)Customed, Inc.1993-08-27
CORDIS CATHETER SHEATH INTRODUCER (K932733)Cordis Corp.1993-08-26
PRO-FLO SYSTEM (K931896)Lafayette Pharmacal, Inc.1993-08-26
PENCIL POINT SPINAL NEEDLE (K921683)Hart Enterprises, Inc.1993-08-26
RES Q AIR SYSTEM MODEL HT-1000 (K926161)C.F. Electronics, Inc.1993-08-26
PSORALITE (K930856)Daavlin Co.1993-08-26
CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON (K925466)Uni-Patch, Inc.1993-08-26
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (K933426)Baxter Diagnostics, Inc.1993-08-26
AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS (K932292)Medrad, Inc.1993-08-26
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS (K932549)Roche Diagnostic Systems, Inc.1993-08-26
AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY) (K924667)Vortran Medical Technology 1, Inc.1993-08-26
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL (K914802)Datascope Corp.1993-08-25
RADIAS B12 ENZYME IMMUNOASSAY (K933315)Bio-Rad1993-08-25
KOMET MEDICAL SURGICAL POWER ACCESORIES (K930109)Brassler USA1993-08-25
INSUFFLATOR TUBING KIT W/FILTER (K933661)Eagle Medical, Inc.1993-08-25
DENRICK SPEECH AID (DR-1) (K931371)Denrick Corp.1993-08-25
TRIGLYCERIDES (K931891)Em Diagnostic Systems, Inc.1993-08-25
PROBE PERSONAL PREFERENCE NON-STER. PAT. EXAM.GLOV (K930903)Glove India Private , Ltd.1993-08-25
POWDER-FREE LATEX EXAMINATION GLOVES (K930407)Influx Pacific Sdn. Bhd.1993-08-25
ANGEMED 5000 LEAD ADAPTER (K924390)Angemed, Inc.1993-08-25
DATASCOPE MULTINEX II (K926451)Datascope Corp.1993-08-25
MODISSA 90 S.R.L. SPECTACLE FRAMES (K930857)Modissa 90 Srl1993-08-25
VLC DR MATERIAL (K932395)Dentsply Intl.1993-08-25
MARK I HUMIDIFIER (K932570)C.F. Electronics, Inc.1993-08-25
ECLIPSE 2100(TM) MODEL 32, MODIFICATION (K931101)Cardiogenes1993-08-25
TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT (K924050)Orthomet, Inc.1993-08-25
FEMORAL INTRAMEDULLARY RODS (K926465)Applied Osteo Systems, Inc.1993-08-25
KING SODIUM/POTASSIUM STANDARD MODIFIED (K931834)King Diagnostics, Inc.1993-08-25
LANGGASSE 90 (K932470)Happersberger Otopront GmbH1993-08-25
VASCO TIP/VASCOFLANGE (K913831)Vascor Medical Corp.1993-08-25
FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT (K931346)Ferno1993-08-25
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON (K911000)Datascope Corp.1993-08-25
BISCO D/C CORE COMPOSITE (K930405)Bisco, Inc.1993-08-24
L.C.S.3000 (K926464)Cryodyne Technologies, Inc.1993-08-24
ENDOSCOPIC ANTI-FOG KIT, 100-302-00 (K933520)Avail-Southwest Division1993-08-24
LAPRA-TY* SUTURE CLIP (K931492)ETHICON, Inc.1993-08-24
INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR (K921481)Acufex Microsurgical, Inc.1993-08-24
LATEX EXAMINATION GLOVES (POWDER FREE) (K926526)Rantran, Inc.1993-08-24
LACEY REVISION FEMORAL COMPONENT (K925900)Dow Corning Wright1993-08-24
SRUGICAL RETRACTOR, MODIFICATION (K933049)Advanced Surgical, Inc.1993-08-24
I.D.A. SYRINGES (K931632)Pt Hasoon Chandra1993-08-24
PULPDENT DENTAL BOND ENHANCER 2-B (K931710)Pulpdent Corp.1993-08-24
MEDTRONIC ARTERIAL FILTER (K926413)Medtronic Vascular1993-08-24
TRANSSEPTAL INTRODUCER SET (K932619)Thomas Medical Products, Inc.1993-08-24
GLENROE PLASTIC BRACKET (K932920)Glenroe Technologies1993-08-24
MEDCAM (K925967)Medcam USA, Inc.1993-08-24
MINVASIVE SUTURE BONE FASTENER (K924034)Innovasive Devices, Inc.1993-08-24
PROFAST(R)-DENTURE ADHESIVE CREAM (K930336)Fittydent-Altwirth & Schmitt GmbH1993-08-24
HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES (K930139)Shun Thai Rubber Gloves Industry Co., Ltd.1993-08-24
CLARUS ENDOSCOPIC HOOK KNIFE (K925741)Clarus Medical Systems, Inc.1993-08-24
VASCOSCREW 6/60 AND VASCOSCREW 8/60 (K914121)Vascor Medical Corp.1993-08-24
ROTABLATOR, MODIFICATION (K933238)Heart Technology, Inc.1993-08-24
COULTER MH015 (DIFFERENTIAL CELL COUNTER) (K930913)Coulter Corp.1993-08-23
EYE SPOT CRP TEST (K932180)J.S. Medical Assoc.1993-08-23
LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) (K930198)Forda (China) Optical Co.1993-08-23
CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) (K925524)Cardio Metrics, Inc.1993-08-23
CASCADE M, CAT. NO. 1710 (K931956)Helena Laboratories1993-08-23
SYNELISA TG ANTIBODIES/TPO ANTIBODIES (K933123)Elias U.S.A., Inc.1993-08-23
TELEPULSE (K925040)Biometrix , Ltd.1993-08-23
MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID (K933579)Telex Communications, Inc.1993-08-23
MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID (K933291)Maico Hearing Instruments, Inc.1993-08-23
METHADONE METABOLITE EIA ASSAY (K931780)Diagnostic Reagents, Inc.1993-08-23
SPECTRUM MARK I SPECIAL PROCEDURES TABLE (K931563)Spectrum X-Ray Corp.1993-08-23
EYE SPOT RF TEST (K932437)J & S Medical Assoc., Inc.1993-08-23
RHEUMELISA II HISTONE ANTIBODY TEST KIT (K932679)Biowhittaker Molecular Applications, Inc.1993-08-23
ACE CLINICAL CHEMISTRY SYSTEM (K930104)Schiapparelli Biosystems, Inc.1993-08-23
COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY (K932030)Coulter Corp.1993-08-23
MULTIFOCUS COMPACT BTE HEARING AID (K933307)Oticon, Inc.1993-08-23
ELECTRA 1600C AUTOMATIC COAGULATION TIMER (K931206)Medical Laboratory Automation Systems, Inc.1993-08-23
SYLNELISA HISTONE ANTIBODIES (K932302)Elias U.S.A., Inc.1993-08-23
INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER (K924737)Becton Dickinson Vascular Access, Inc.1993-08-23
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM (K933447)GE Medical Systems1993-08-23
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