Atlas FDA

1997

4,309 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR (K963764)Specialty Ultravision, Inc.1997-01-30
CES VASCULAR OCCLUSION SYSTEM (K964367)Cordis Neurovascular, Inc.1997-01-30
DISETRONIC D-MODEM (K961975)Disetronic Medical Systems1997-01-30
VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT (K964612)Vistakon, Johnson & Johnson Vision Products, Inc.1997-01-30
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (K965105)U.S. Imaging Tables, Inc.1997-01-30
DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES (K962813)Maxxim Medical1997-01-30
GE STERILE DISPOSABLE EQUIPMENT COIL COVER (K964141)Contour Fabricators, Inc.1997-01-30
POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367 (K964456)Medtronic Minimed1997-01-30
CW ACUPUNCTURE NEEDLES (K964529)Lhasa Medical, Inc.1997-01-30
WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM (K964436)Western Surgical Instrument Co.1997-01-30
BIPAP DUET SYSTEM (K964363)Respironics, Inc.1997-01-30
P1OP2B OR P1O92T (K954674)Kay Borch A/S1997-01-30
PATHFINDER (K955802)Cardima, Inc.1997-01-29
KSEA PUNCTURE CANNULA (K964379)KARL STORZ Endoscopy-America, Inc.1997-01-29
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM (K962291)Siemens Medical Solutions USA, Inc.1997-01-29
PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM (K922668)Colin Medical Instruments Corp.1997-01-29
GYRO TIP EP CATHETER (K955847)Cardiac Assist Devices, Inc.1997-01-29
WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE (K961897)Wilson-Cook Medical, Inc.1997-01-29
PH ANALYSIS MODULE (K961346)Synectics-Dantec1997-01-29
EAGLE EYES (K964366)Mech-Tronic Precision Mfg., Ltd.1997-01-29
SENNA (K964744)Trans-America Enterprises Corp.1997-01-29
SUNGLASSES (K964564)Micron Metal & Plastic Manufactory Co.1997-01-29
DILATION CATHETER, BALLOON (K965067)Boston Scientific Corp1997-01-28
TRANSEND GUIDEWIRE (K964611)Boston Scientific Corp1997-01-28
DALE ENDOTRACHEAL TUBE HOLDER 270/280 (K964399)Dale Medical Products, Inc.1997-01-28
EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM (K964919)Emerald Medical, Inc.1997-01-28
TORQUE DEVICE (K964352)B.Braun Medical, Inc.1997-01-28
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP) (K962689)Cobe Cardiovascular, Inc.1997-01-28
VIDAMED MODEDL 7600 RF GENERATOR (K965061)Vidamed, Inc.1997-01-28
SOF. PRESS EPC 51 SYSTEM (K963067)Gaymar Industries, Inc.1997-01-28
SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES (K970056)Woodbine Optical Corp.1997-01-28
JOBST ATHROMBIC PUMP SYSTEM 2100 (K963929)Jobst A Beiersdorf Co.1997-01-27
MODEL D-290P ADMINISTRATION SET (K964384)Patient Solutions, Inc.1997-01-27
AUDIOTONE (A-552) (K965063)Miracle-Ear, Inc.1997-01-27
ANEROID AND MERCURIAL SPHYGMOMANOMETERS (K962655)American Diagnostic Corp.1997-01-27
DG NERVUS (K964280)Medelec , Ltd.1997-01-27
GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON (K963509)Smith & Nephew Richards, Inc.1997-01-27
AUDIOTONE (A554H) (K965057)Miracle-Ear, Inc.1997-01-27
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION) (K963946)Osteonics Corp.1997-01-27
COMPLEAT SURGICAL MASK (K962654)Carl Parker Associates, Inc.1997-01-27
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT (K964395)Hayes Medical, Inc.1997-01-27
THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE (K963675)Micro-Medical Devices, Inc.1997-01-27
LR 5200 LASER FILM RECORDER (K964414)Bayer Corp., Agfa Div.1997-01-27
S.A.M. FACIAL IMPLANT W/INTRODUCER (K964761)W. L. Gore & Associates, Inc.1997-01-27
ECLIPSE 2000 (K961560)Cardiogenes1997-01-27
METAL BACKED ACETABULAR COMPONENT (K963998)Encore Orthopedics, Inc.1997-01-27
H.PYLORI CONTROLS (K964675)Pyramid Biological Corp.1997-01-27
AQUABOND ELECTRODE (K964433)Medibond , Ltd.1997-01-27
DAHLBERG (A-554) (K965049)Miracle-Ear, Inc.1997-01-27
FLUOROVIEW SERIES FLUOROSCOPIC TABLES (K965096)U.S. Imaging Tables, Inc.1997-01-27
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) (K965048)Johnson & Johnson Clinical Diagnostics, Inc.1997-01-27
HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT (K962854)Cardio Control BV1997-01-27
KODAK MINILOADER(2000) (K970059)Eastman Kodak Company1997-01-27
PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT (K965072)Kaycor Intl., Ltd.1997-01-27
NATURAL-HIP SYSTEM COCR STEM (K964357)Intermedics Orthopedics1997-01-27
DYNAMOMETER (K964685)John Chatillon & Sons, Inc.1997-01-27
FLEXIBLE URETEROSCOPE (K964482)Applied Fiberoptics, Inc.1997-01-24
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST (K970082)Abbott Laboratories1997-01-24
FINN ROD TO ROD CONNECTOR (K960444)Smith & Nephew Richards, Inc.1997-01-24
FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES (K964317)Nantong Ruchang Latex Products Co., Ltd.1997-01-24
MEDTEXX (K963331)Regalfield Sdn. Bhd.1997-01-24
THE ROBOLITE (K964460)Shai Syg Motion and Innovations, Ltd.1997-01-24
AXIOM INF (K964423)Axiom Manufacturing1997-01-24
PENCIL (K965054)Megadyne Medical Products, Inc.1997-01-24
INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) (K964577)Empi1997-01-24
M11 SERIES: M11, M11M (K965088)Philips Hearing Instruments Co.1997-01-24
VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE (K964649)Howmedica Leibinger, Inc.1997-01-24
A LITHOTRIPTER-COMPATIBLE BASKET (K964937)Boston Scientific Corp1997-01-24
HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION (K964746)GE Medical Systems1997-01-24
FERR FLEX REAGENT CARTRIDGE (K963498)Dade Chemistry Systems, Inc.1997-01-24
WHEELCHAIR BELT (K963479)Deroyal Industries, Inc.1997-01-24
TAP (K964516)Nellcor Puritan Bennett, Inc.1997-01-24
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES (K965156)Johnson & Johnson Professionals, Inc.1997-01-24
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM (K964704)Depuy, Inc.1997-01-24
OPUS BONE ALP (K964764)Behring Diagnostics, Inc.1997-01-24
KARTUSH TM PATCHER (K964484)Xomed, Inc.1997-01-24
BONESOURCE HYDROXYAPATITE CEMENT (HAC) (K964537)Osteogenics, Inc.1997-01-24
MICRO H2 (K963376)Micro Direct, Inc.1997-01-24
COMFORTAID HEARING AID (K964680)Ethical Hearing Instruments1997-01-24
ELECSYS LH ASSAY (K964694)Boehringer Mannheim Corp.1997-01-24
SOMA SAFE ENCLOSURE (K963701)Nova Technology Corp.1997-01-24
DERLIN (K964817)Derlin Company , Ltd.1997-01-24
SENSO DIGITAL (C18) (K965218)Widex Hearing Aid Co., Inc.1997-01-24
PROFILE 70000 QUADRATURE VOLUME NECK COIL (K964531)Us Asia Instruments, Inc.1997-01-24
TONY RISO 25/30 MULTIFUNCTION SCALER (K964320)Tony Riso Co., Inc.1997-01-23
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (K962492)Nidek Medical Products, Inc.1997-01-23
OLYMPUS CRITICAL CARE MONITORING SYSTEM (K963935)Optical Sensors, Inc.1997-01-23
PERCUPUMP II WITH EDA (K961845)E-Z-Em, Inc.1997-01-23
SILENT NIGHT I (K963597)Local Silence, Inc.1997-01-23
FIRST TOUCH DISPOSABLES TEMPERATURE PROBES (K950422)First Touch Disposables, Inc.1997-01-23
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM (K964402)V. Mueller Neuro/Spine1997-01-23
PERFORMR SERIES EP DIAGNOSTIC CATHETERS (K964272)Medtronic Cardiorhythm1997-01-23
TILTING RADIOGRAPHIC TABLE (REMOTE) (K963851)Acoma Medical Imaging, Inc.1997-01-23
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS (K963739)Howmedica Leibinger, Inc.1997-01-22
TUXEDO VEST RESTRAINT (K963474)Deroyal Industries, Inc.1997-01-22
STRYKER TEMPEST ORTHOPEDIC PUMP (K963304)Stryker Endoscopy1997-01-22
CALCIUM HYDROXIDE MEDICAMENT (K964191)Sybron Dental Specialties, Inc.1997-01-22
RESTRICTIVE LIMB HOLDER (K963468)Deroyal Industries, Inc.1997-01-22
COHERENT ULTRAPULSE CO2 SURGICAL LASERS (K963339)Coherent Medical Group1997-01-22
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY (K954717)Sodem Diffusion SA1997-01-22
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Every clearance here is in the API, with alerts when new ones post.