Atlas FDA

1996

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

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RecordFirmDate
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS (K964121)Boston Scientific Scimed, Inc.1996-12-04
PHONAK MICROLINK, PERSONAL FM RECEIVER (K964035)Phonak, Inc.1996-12-04
TFX MEDICAL GUIDEWIRE (K963320)Tfx Medical Group1996-12-03
FERRITIN CALIBRATOR (K963493)Dade Chemistry Systems, Inc.1996-12-03
POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P (K960970)Possis Medical, Inc.1996-12-03
FIBREKOR (K964578)Jeneric/Pentron, Inc.1996-12-03
SPECTRA SCIENCE BIOPSY FORCEPS (K963517)Spectrascience, Inc.1996-12-02
MIDSTREAM ONESTEP PREGNANCY HOME TEST (K963341)Syntron Bioresearch, Inc.1996-12-02
PATIENT RESTRAINTS (K963906)Safety Intl., Inc.1996-12-02
TOUCH N' HEAT (K963862)Sybron Dental Specialties, Inc.1996-12-02
DAVOL PLUME FILTER (5541420) (K964211)Davol Inc., Sub. C. R. Bard, Inc.1996-12-02
THE WRAP IMMOBILIZATION SYSTEM (K963547)Safe Restraints, Inc.1996-12-02
COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A (K963705)Toshiba America Medical Systems, In.C1996-12-02
OZARK 40 (K964477)Gateway Alloys, Inc.1996-12-02
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT (K963170)Olympus America, Inc.1996-12-02
FLEXIBLE MINI-FIBERSCOPES (K962172)Richard Wolf Medical Instruments Corp.1996-12-02
SIMVIEW 3000 CT OPTION (K953233)Siemens Medical Solutions USA, Inc.1996-11-29
NASP TRANSPARENT DRESSING (K963753)North American Sterilization & Packaging Co.1996-11-29
ENZYMUN-TEST FT3 (K962760)Boehringer Mannheim Corp.1996-11-29
GAUZE SPONGE, NON X-RAY DETECTABLE (K963724)Grand Medical Products1996-11-29
NEW COMFORT CONTACT LENS CARE ACCESSORY (K962112)Lens Comfort, Inc.1996-11-29
LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR (K963011)Permeable Technologies, Inc.1996-11-29
QUANTITATIVE FIBRINOGEN ASSAY (K963902)Ortho Diagnostic Systems, Inc.1996-11-29
EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER (K963763)Medica Corp.1996-11-29
CAPILLARY ADAPTOR ACCESSORY (K963992)Medica Corp.1996-11-29
OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) (K962952)Olympus Optical, Co.1996-11-29
OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST (K963693)Princeton BioMeditech Corp.1996-11-29
WATERS 515 HPLC PUMP (515) (K964588)Waters Corporation1996-11-29
GIARDIA CELISA (K963135)Techlab, Inc.1996-11-29
CEP 8 SPECTRUMORANGE DNA PROBE KIT (K953591)Vysis1996-11-29
PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS (K964269)Playtime Products, Inc.1996-11-29
AVL COMPACT 3 PH/BLOOD GAS ANALYZER (K963964)Avl Scientific Corp.1996-11-29
CONTACT LENS WITH COLOR ADDITIVE (K962911)Cal Bionics1996-11-29
KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE (K963029)KARL STORZ Endoscopy-America, Inc.1996-11-27
ADVANCED DIAGNOSTIC VIEWER (ADV) (K963697)Bio-Vascular, Inc.1996-11-27
UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) (K964508)Unitron Industries, Inc.1996-11-27
MINIFIX (K964094)Ferguson Medical1996-11-27
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (K964557)Resound Corp.1996-11-27
GALILEO ENDOSCOPES (K962116)Galileo Electro-Optics Corp.1996-11-27
IV START KIT (K963722)Grand Medical Products1996-11-27
GLOVEL GX (K963020)Kenwell International , Ltd.1996-11-27
DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS (K963487)Ciba Vision Corporation1996-11-27
AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE (K963999)United States Surgical, A Division of Tyco Healthc1996-11-27
AHS OMEGA K-AMP (K963875)Authorized Hearing Systems, Inc.1996-11-27
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT (K964530)Miracle-Ear, Inc.1996-11-27
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC (K964451)Rexton, Inc.1996-11-27
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K963429)GE Medical Systems1996-11-27
HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 (K962195)Sunbeam Health Division1996-11-27
AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES (K963610)A.L.I. Technologies, Inc.1996-11-27
DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY (K963715)Grand Medical Products1996-11-27
MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP (K964109)Microsurge, Inc.1996-11-27
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) (K964510)Unitron Industries, Inc.1996-11-27
GRAND MEDICAL SUTURE REMOVAL KIT (K963714)Grand Medical Products1996-11-27
PRIMOFOCUS COMPACT (K963788)Oticon Corp.1996-11-27
THE PHARAOH COMPENSATING FILTER (K963941)Octostop, Inc.1996-11-27
UNITRON MODEL SOUND F/X +4 (K964503)Unitron Industries, Inc.1996-11-27
SKIN SCRUB TRAY (K963721)Grand Medical Products1996-11-27
INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS (K963598)Innovative Technologies , Ltd.1996-11-27
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) (K964511)Unitron Industries, Inc.1996-11-27
AIA-PACK FOLATE ASSAY (K964349)Tosoh Medics, Inc.1996-11-27
CD HORIZON ANTERIOR SPINAL SYSTEM (K963655)Sofamor Danek USA,Inc.1996-11-27
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) (K964310)Johnson & Johnson Clinical Diagnostics, Inc.1996-11-27
REVISION HIP SYSTEM (K963486)Smith & Nephew Richards, Inc.1996-11-27
INCARE HOT/ICE LITE MACHINE (K962537)Hollister, Inc.1996-11-27
KONSTRUCT PATELLAR COMPONENT (K960856)Biomet, Inc.1996-11-27
PRODIGY AC (K963805)Sybron Dental Specialties, Inc.1996-11-27
QUASAR RECOVERY IMAGING PACKAGE (K962481)Trionix Research Laboratory, Inc.1996-11-27
CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (K963719)Grand Medical Products1996-11-27
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS (K964244)Starkey Laboratories, Inc.1996-11-27
TRACHEOSTOMY KIT (K963720)Grand Medical Products1996-11-27
UNITRON MODEL SOUND F/XP +4 (K964502)Unitron Industries, Inc.1996-11-27
COJET SYSTEM (K963735)Espe GmbH & Co. Kg.1996-11-27
ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE (K962570)Gallini Intl., Inc.1996-11-27
BIOMID BONE MARROW BIOPSY NEEDLE (K962569)Gallini Intl., Inc.1996-11-27
DERMAGRAN HYDROPHILIC OINTMENT (K963603)Derma Sciences, Inc.1996-11-27
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS (K964214)Starkey Laboratories, Inc.1996-11-27
EASYLYTE CALCIUM/CHLORIDE ANALYZER (K963694)Medica Corp.1996-11-27
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K962061)GE Medical Systems1996-11-27
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT (K962217)Gen-Probe, Inc.1996-11-27
UNITRON MODEL ICON AOHPL +4 (K964504)Unitron Industries, Inc.1996-11-27
ISOLA PEDIATRIC COMPONENTS (K962984)Acromed Corp.1996-11-27
PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF (K964144)Para Scientific Co.1996-11-27
SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM (K963798)Synthes (Usa)1996-11-27
LACERATION TRAY (K963723)Grand Medical Products1996-11-27
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) (K964308)Johnson & Johnson Clinical Diagnostics, Inc.1996-11-27
AHS OMEGA DEQ (K963873)Authorized Hearing Systems, Inc.1996-11-26
MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) (K963745)Hearing Innovations, Inc.1996-11-26
AHS DELTA 22 (K963879)Authorized Hearing Systems, Inc.1996-11-26
PACIFIC 52 (CB-39) (K964464)Gateway Alloys, Inc.1996-11-26
OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING (K962623)Procyte Corp.1996-11-26
MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE (K963704)Shippert Medical Technologies Corp.1996-11-26
AHS OMEGA PP (K963876)Authorized Hearing Systems, Inc.1996-11-26
9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD (K963677)9th Wave, Inc.1996-11-26
AUDIO 'D' SOUND SELECTOR POWER (SSP) (K964180)Hearing Solutions, Inc.1996-11-26
BIOZ SYSTEM (K963183)Cardiodynamics International Corp.1996-11-26
NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER (K963400)Nellcor Puritan Bennett, Inc.1996-11-26
ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES (K963189)Erbe USA, Inc.1996-11-26
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER (K963995)Starkey Laboratories, Inc.1996-11-26
TEST-MATE CHE CHOLINESTERASE TEST SYSTEM (K961656)Eqm Research, Inc.1996-11-26
OSAGE 76 (K964478)Gateway Alloys, Inc.1996-11-26
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Every clearance here is in the API, with alerts when new ones post.