Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TBD AT-HOME PREGNANCY TEST (K961712)Armkel, LLC1996-05-31
ACTICOAT SILVER COATED DRESSING (K955453)Westaim Technologies, Inc.1996-05-31
AS/3 CARDIAC OUTPUT & SVO2 MODULE (K961063)Datex Medical Instrumentation, Inc.1996-05-31
ACCUSIGN, BIOSIGN PCP (K961266)Princeton BioMeditech Corp.1996-05-31
SUNGLASSES (K960953)Galilee Optics1996-05-31
MISTRAL SUNGLASSES (K960668)Mistral Optical1996-05-31
SUNGLASSES (K960818)Visard Srl1996-05-31
CLOSED FLUID COLLECTION SYSTEM (K961147)B.Braun Medical, Inc.1996-05-31
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH (K961440)Fusion Medical Technologies, Inc.1996-05-31
SAS SHIGELLA SONNEI FORM II ANTISERUM (K961537)Sa Scientific, Inc.1996-05-31
INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY (K961713)KARL STORZ Endoscopy-America, Inc.1996-05-31
LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING (K961452)Acme United Corp.1996-05-31
LARYNGOSCOPE COVER (K945301)Sotiria Mourkidou, M.D.1996-05-31
PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) (K960449)Biosensor Corp.1996-05-30
BREATHE RIGHT NASAL STRIP (K955711)Cns, Inc.1996-05-30
DIASTAT ANTI-CARDIOLIPIN KIT (K955303)Shield Diagnostics, Ltd.1996-05-30
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT (K955460)Meadox Medicals, Div. Boston Scientific Corp.1996-05-30
H292 CELL CULTURE (K960909)Neogenex1996-05-30
GASTRIN EIA MODEL 06B-555017 (K961276)Biosyn , Ltd.1996-05-30
DIRECTIGEN MENINGITIS COMBO TEST (K952791)Bd Becton Dickinson Vacutainer Systems Preanalytic1996-05-30
KENDALL BLUNT TUOHY EPIDURAL NEEDLE (K954706)Kendall Healthcare Products Co. Div.Of Tyco Health1996-05-30
UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE (K961236)United Biotech, Inc.1996-05-30
IMX SELECT CHLAMYDIA (K936054)Abbott Laboratories1996-05-30
TAS HMT CONTROLS (K960234)Cardiovascular Diagnostics, Inc.1996-05-30
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (K955905)Solarcare Technologies Corp,Inc.1996-05-30
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL (K961042)Dade Microscan, Inc.1996-05-30
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT (K960983)Medtronics Interventional Vascular1996-05-30
BEHRING COAGULATION TIMER (K955278)Behring Diagnostics, Inc.1996-05-30
BEC SHROUDED PLASTIC CANNULA (K961328)Biological & Environmental Control Laboratories1996-05-30
TAYLOR GENERAL PURPOSE MONITORING ELECTRODE (K954951)Taylor Industries, Inc.1996-05-30
LIFE AND LIFE FAST SET (K961708)Sybron Dental Specialties, Inc.1996-05-30
VENTANNA ANTI-CD3 PRIMARY ANTIBODY (K941505)Ventana Medical Systems, Inc.1996-05-30
VENTRAK RMMS 1550 (K960831)Novametrix Medical Systems, Inc.1996-05-29
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE (K960911)Scimage, Inc.1996-05-29
ISG VIEWING WAND (K960714)I.S.G. Technologies, Inc.1996-05-29
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES (K960859)Porex Technologies Corp. of Georgia1996-05-29
ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR (K961743)Pdg Product Design Group, Inc.1996-05-29
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL (K960901)Medrad, Inc.1996-05-29
OCCLUSION BALLOON CATHETER (K960832)Interventional Therapeutics Corp.1996-05-29
MOVABLE ADD-ON COUCH FOR OUTLOOK (K960973)Philips Medical Systems (Cleveland), Inc.1996-05-29
ARGOSY PROGRAMMABLE (K961729)Argosy Electronics1996-05-29
ELECTRIC SEAT LIFT CHAIR (K961663)Ken Kemmerer1996-05-29
ERYTHROPOIETIN IMMUNOASSAY KIT (K952559)Nichols Institute1996-05-29
SOLAR 9000 ANESTHESIA INFORMATION MONITOR (K954852)Marquette Electronics, Inc.1996-05-29
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT (K961447)Bio-Logic Systems Corp.1996-05-29
STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200 (K960956)Sterngold/Implamed1996-05-29
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) (K960466)Abbott Laboratories1996-05-29
PHONAK SONA P2 (K961653)Phonak, Inc.1996-05-29
ENERGIZED CONTAINER SYSTEM (MODIFICATION) (K954283)Abbott Laboratories1996-05-29
EMERALD STERILE GAUZE SPONGE (K961581)Emerald Medical, Inc.1996-05-28
MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS (K945559)Mar Cor Services, Inc.1996-05-28
INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP (K961430)Innerdyne, Inc.1996-05-28
PERRY SPECIALTIES DESIGNS NEEDLE GUARD (K932889)Perry Specialties Design, Inc.1996-05-28
JAZZY (K945936)Pride Health Care, Inc.1996-05-28
TELESCOPING PENEVAC (MODIFICATION) (K961616)I.C Medical, Inc.1996-05-28
FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS (K961291)Dentsply Intl.1996-05-28
HIGH RISK GLOVES (K955241)Pan-Century Rubber Products Sdn. Bhd.1996-05-28
AQ HYDROPHILIC STENT (K961446)Cook Urological, Inc.1996-05-28
PARACENTESIS TRAYS (K961863)Tri-Med, Inc.1996-05-28
SULLIVAN NOSE & MOUTH MASK SYSTEM (K952475)Rescare , Ltd.1996-05-28
PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 (K954884)Vingmed Sound, Inc.1996-05-28
KODAK EC-L CASSETTE (K960834)Eastman Kodak Company1996-05-28
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM (K961069)Arthrocare Corp.1996-05-28
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS (K961248)C.R. Bard, Inc.1996-05-28
MONOTUBE TUBE TO RING CLAMP (K961618)Howmedica Corp.1996-05-28
TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) (K954258)Gerard Medical Enterprises, Inc.1996-05-24
POWDER FREE LATEX EXAMINATION GLOVE (K960467)Biopro, Inc.1996-05-24
GC FUJI ORTHO (K961417)GC America, Inc.1996-05-24
BOSWORTH CH I (K961198)Harry J. Bosworth Co.1996-05-24
BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 (K955840)Diagnostic Ultrasound Corp.1996-05-24
BRANNON PORTSYRINGE (K960049)James K. Brannon1996-05-24
IMZ MEMBRANE TACK SYSTEM (K960945)Interpore Intl.1996-05-24
BRANNON PEDI PORTSYRINGE (K960047)James K. Brannon1996-05-24
CD-CHEX + RBC (K960894)Streck Laboratories, Inc.1996-05-24
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 (K955633)Diagnostic Chemicals , Ltd.1996-05-24
GREEN TEC-2100 (K955236)Medtec, Inc.1996-05-24
STENODOC (K946349)Specs USA, Inc.1996-05-24
LA POSITIVE CONTROL PLASMA (K961370)Medical Diagnostic Technologies, Inc.1996-05-24
DISETRONIC MULTIFUSE PUMP SYSTEM (K954826)Disetronic Medical Systems1996-05-24
EKTACHEM DT LDL CHOLESTEROL KIT (K955904)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-24
FUJI II LC (IMPROVED) (K961584)GC America, Inc.1996-05-24
OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS (K960022)Opti-Max1996-05-24
CPR C-SECTION DELIVERY PACK (K960243)Custom Pack Reliability1996-05-23
RIBOSOMAL P EIA TEST SYSTEM (K950169)Hogan & Hartson1996-05-23
CPR D & C TRAY (K960239)Custom Pack Reliability1996-05-23
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY (K955449)American Laboratory Products Co., Ltd.1996-05-23
PREMIER HSV PLUS (K953839)Meridian Diagnostics, Inc.1996-05-23
BUHLMANN VITAMIN B6 REA (K955561)American Laboratory Products Co., Ltd.1996-05-23
CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (K960755)Medtronic Cardiac Surgery, Medtronic, Inc.1996-05-23
MANAN INTRODUCER SHEALTH/NEEDLE (K961216)Manan Medical Products, Inc.1996-05-23
VISUWELL REAGIN II (K952802)Biomira Diagnostics, Inc.1996-05-23
HANDMASTER NMS1 (K952273)Neuromusclar Electrical Stimulation Systems, Ltd.1996-05-23
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP (K955180)Sims Deltec, Inc.1996-05-23
MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR (K960777)Mdt Corp., Inc.1996-05-23
CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) (K953205)Fisher & Paykel Healthcare, Ltd.1996-05-23
SUPRASSON P5 BOOSTER (K961158)Satelec1996-05-23
CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING (K960931)Carolina Narrow Fabric Co.1996-05-23
AST INCORPORATING DST (K961114)Trace Scientific , Ltd.1996-05-23
PRECLUDE IMA SLEEVE (K960532)W. L. Gore & Associates, Inc.1996-05-23
NCI-H292 CELL CULTURE (K951461)Viromed Laboratories, Inc.1996-05-22
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Track 1996 automatically

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