Atlas FDA

1996

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

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RecordFirmDate
INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) (K964006)Hollister, Inc.1996-12-31
AS 123 PROSTHETIC INSTRUMENTATION SYSTEM (K963951)BioHorizons Implant Systems, Inc.1996-12-31
TIELLE HYDROPOLYMER FOAM DRESSING (K964016)Johnson & Johnson Medical, Inc.1996-12-31
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (K964127)Allegiance Healthcare Corp.1996-12-31
TAKI ACUPUNCTURE NEEDLES (K964411)Lhasa Medical, Inc.1996-12-31
TRUS<T>LIFT PORCH LIFT (K964134)Trus T Lift1996-12-31
ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 (K964515)M.C. Healthcare Products, Inc.1996-12-31
INCARE HOT/ICE SYSTEM SHOULDER BLANKET (K964057)Hollister, Inc.1996-12-31
OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM (K963184)Olympus America, Inc.1996-12-31
DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG (K964070)Deknatel, Inc.1996-12-31
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 (K964145)Crystal Mark, Inc.1996-12-31
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM (K955425)Dash Medical Gloves Sdn Bhd1996-12-30
ACU-HALT (K955661)Glederer & Co., Inc.1996-12-30
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE (K964563)Omni Sales Corp.1996-12-30
SHOE COVER, NON-STERILE (K961342)Copioumed Intl., Inc.1996-12-30
INJECTO FLUSH (K964120)Robert J. Jynch, Jr.1996-12-30
ISOLATION GOWN (K960999)Copioumed Intl., Inc.1996-12-30
POWDER FREE VINYL EXAMINATION GLOVE (K964545)Shanghai Poseidon Plastic Products Co., Ltd.1996-12-30
KROMALGIN IMPRESSION MATERIAL (K964177)North American Orthodontic Laboratories, Inc.1996-12-30
TRIMAX NAIL SYSTEM (K964163)Smith & Nephew Richards, Inc.1996-12-27
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD (K964262)Exactech, Inc.1996-12-27
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS (K962309)Althin Medical AB an Affiliate of Baxter Intl1996-12-27
UM-D3000/UM-D4000 (K963985)J.J. Consulting Services, Inc.1996-12-27
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM (K962486)Depuy, Inc.1996-12-27
CORAIL (K953111)Landos, Inc.1996-12-27
WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD (K964150)Whiteside Biomechanics, Inc.1996-12-27
FOUNDATION KNEE SYSTEM (K964008)Encore Orthopedics, Inc.1996-12-27
NEEDLE'S EYE SNARE (K961992)Cook Pacemaker Corp.1996-12-27
STC AUTO-LYTE URINARY GLUCOSE ASSAY (K962435)OraSure Technologies, Inc.1996-12-26
IMAGEN RESPIRATORY SCREEN (K962037)Dako Diagnostics , Ltd.1996-12-26
ALBA HEALTH PAS WRAP SYSTEM (K961405)Alba-Waldensian, Inc.1996-12-26
MIRACLE-EAR OR AUDIOTONE (K964669)Miracle-Ear, Inc.1996-12-26
MODEL 5500 CEAS (K963938)Esa, Inc.1996-12-26
UREA NITROGEN (BUN) LIQUI-UV (K962418)Stanbio Laboratory1996-12-26
CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA (K964637)Medical Packaging Corp.1996-12-24
COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE (K964060)Travenol Laboratories (Israel) , Ltd.1996-12-24
NEO-CARE DUAL LUMEN UMBILICAL CATHETER (K963972)Klein-Baker Medical, Inc.1996-12-24
HEMODIALYSIS INTRODUCER SET (K961780)Thomas Medical Products, Inc.1996-12-24
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (K962601)Nichols Institute Diagnostics1996-12-24
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX (K960915)Clarus Medical Systems, Inc.1996-12-24
WAKO DIRECT HDL-C (K963847)Wako Chemicals USA, Inc.1996-12-24
BRIO AUTOMATIC SAMPLINC UNIT (K961209)Seac S.R.L.1996-12-24
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964116)Bayer Corp.1996-12-24
CIDE-SWIPES P-100B & CIDE-SWIPES C-100A (K964376)Mp Scientific, Inc.1996-12-23
BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY (K963699)Belmont Equipment Corp.1996-12-23
PHILIPS EASYVISION (K963980)Philips Medical Systems North America, Inc.1996-12-23
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM (K962226)Johnson & Johnson Medical, Inc.1996-12-23
REP 3 FLUR SPE-60 KIT (K964453)Helena Laboratories1996-12-23
SIEMENS SERVO ULTRA NEBULIZER 345 (K960854)Pacesetter, Inc.1996-12-23
ULTRAMIX (K962093)Sonotech, Inc.1996-12-23
ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM (K964659)Dentsply Intl.1996-12-23
CORNEAL TOPOGRAPHER 200 (K963762)Eclipse Ventures1996-12-23
FLEXART V3.1 SOFTWARE (K962138)Toshiba America Mri, Inc.1996-12-23
ECOLOTION TRANSMISSION AND MASSAGE LOTION (K962840)Eco-Med Pharmaceuticals, Inc.1996-12-23
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S (K963111)Chromogenix AB1996-12-23
VENTANA CEA PRIMARY ANTIBODY (K940242)Ventana Medical Systems, Inc.1996-12-23
SI CONTROLLER MODEL SI 500 (K960492)I.C Medical, Inc.1996-12-23
CONVERTORS DRAPE MATERIAL (K964125)Allegiance Healthcare Corp.1996-12-23
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH (K963795)Vision-Sciences, Inc.1996-12-23
H.A.M. APPLICATOR (K961601)Mick Radio-Nuclear Instruments, Inc.1996-12-23
CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1 (K964618)Coulter Corp.1996-12-23
MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA (K960982)Sherwood Medical Co.1996-12-23
DAHLBERG K-AMP BTE (K964794)Miracle-Ear, Inc.1996-12-23
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM (K964031)Slt-J , Ltd.1996-12-23
PHARMACIA CAP SYSTEM RAST FEIA (K962976)Pharmacia & Upjohn Co.1996-12-23
THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM (K963860)Nomos Corp.1996-12-23
REP FLUR CHOLESTEROL-60 KIT (K964471)Helena Laboratories1996-12-23
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A (K960948)Toshiba Medical Systems1996-12-23
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) (K964196)Northgate Technologies, Inc.1996-12-23
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM (K963952)Ge Dec Medical Systems1996-12-23
LA PLATA 40 (K964792)Gateway Alloys, Inc.1996-12-20
SAFECIRCUIT MANIFOLD/PULMONARY UNIT (K953269)Advanced Warming Systems, Inc.1996-12-20
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) (K962928)Camino Neurocare, Inc.1996-12-20
CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER (K955265)Cordis Corp.1996-12-20
PACIFIC 56 (CB-40) (K964837)Gateway Alloys, Inc.1996-12-20
LA PLATA 39 (K964789)Gateway Alloys, Inc.1996-12-20
DISPOSABLE NEEDLE ELECTRODE (K961013)Medelec Intl. Corp.1996-12-20
HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN (K963837)Westcon Contact Lens Co., Inc.1996-12-20
A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON (K964621)Alto Development Corp.1996-12-20
ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM (K964215)Smith & Nephew Endoscopy, Inc.1996-12-20
CURITY THORACENTESIS TRAY (K964519)Kendall Healthcare Products Co. Div.Of Tyco Health1996-12-20
BIPAP S/T-D 30 SYSTEM (K955324)Respironics, Inc.1996-12-20
PALLADIA 85 (PM-13) (K964838)Gateway Alloys, Inc.1996-12-20
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) (K962474)Olympus America, Inc.1996-12-20
RUBASCAN CARD TEST (K952721)Bd Becton Dickinson Vacutainer Systems Preanalytic1996-12-20
EL DORADO 55 (K964788)Gateway Alloys, Inc.1996-12-20
KSEA UNIMAT PLUS (K963960)KARL STORZ Endoscopy-America, Inc.1996-12-20
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS (K964774)Fci Ophthalmics, Inc.1996-12-20
VITLITE (TR7700) (K963417)Escalon Trek Medical1996-12-20
SURGIFORM ANATOMICAL MALAR (K964443)Surgical Technology Laboratories, Inc.1996-12-20
NPB-4000 (K962424)Analogic Corp.1996-12-20
AUTO SUTURE* ABBI* SYSTEM (K963825)United States Surgical, A Division of Tyco Healthc1996-12-20
VERGE VIDEOMETER (K962148)Verg, Inc.1996-12-20
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (K964222)Paladin Medical, Inc.1996-12-20
NITRILE COPOLYMER PATIENT EXAMINATION GLOVES (K962518)P.T. Irama Dinamika Latex1996-12-19
CHLOROPRENE EXAM GLOVES (K963771)P.T. Irama Dinamika Latex1996-12-19
SAFESKIN (K962139)Safeskin Corp.1996-12-19
IRT LOCKING SYRINGE (K945410)Interventional Research Technologies1996-12-19
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION) (K963959)Osteonics Corp.1996-12-19
PELVIC HOLDER (K963465)Deroyal Industries, Inc.1996-12-19
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Every clearance here is in the API, with alerts when new ones post.