Atlas FDA

1997

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

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RecordFirmDate
AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES (K972646)Ludlow Technical Products1997-08-21
TOA (K972061)W. Keith Thornton, D.D.S.1997-08-21
INSIGHT 7000 PHASED ARRAY TORSO COIL (K972340)Usa Instruments, Inc.1997-08-21
QUICK SCREEN ONE STEP AMPHETAMINE TEST (K972577)Phamatech1997-08-20
CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971638)Oxoid , Ltd.1997-08-20
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH (K972310)Nihon Kohden America, Inc.1997-08-20
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (K972449)Copan Italia Spa1997-08-20
EBI SPINELINK SYSTEM (K971970)Electro-Biology, Inc.1997-08-20
IMMUNOCARD STAT! ROTAVIRUS (K971585)Meridian Diagnostics, Inc.1997-08-20
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM (K971894)Eastman Kodak Company1997-08-20
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) (K972619)Phamatech1997-08-20
MEDNEXT 1000 DRILL (K972308)Mednext, Inc.1997-08-20
JEJENOSTOMY FEEDING TUBE (K971906)Boston Scientific Corp1997-08-20
THE PERIOSEAL DENTAL IMPLANT (K965032)Perioseal1997-08-20
PASCO MIC AND MIC/ID PANELS (K972567)Pasco Laboratories, Inc.1997-08-20
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (K972448)Copan Italia Spa1997-08-20
INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK (K972427)Custom Services Intl., Inc.1997-08-20
ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD (K971677)Transamerican Technologies Intl.1997-08-20
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT (K971958)Beckman Instruments, Inc.1997-08-20
MYCOPLASMA IGM ELISA TEST SYSTEM (K971503)Zeus Scientific, Inc.1997-08-20
ASSET APOLLO (K971884)Philips Medical Systems (Cleveland), Inc.1997-08-20
OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS (K972303)Ocular Sciences Puerto Rico, Inc.1997-08-20
AVL 9181 ELECTROLYTE ANALYZER (K972673)Avl Scientific Corp.1997-08-20
DM-400 HOLTER ECG CASSETTE RECORDER (K970298)Diagnostic Monitoring1997-08-20
QUIKSTRIP ONE STEP OPIATES TEST (K972571)Drial Consultants, Inc.1997-08-20
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) (K972861)Instrumentation Laboratory CO1997-08-19
NIAGARA DUAL LUMEN CATHETER (K965178)Vas-Cath, Inc.1997-08-19
REGULUS NAVIGATOR (K964229)Compass Intl., Inc.1997-08-19
ORIGIN CARDIAC STABLIZER OCCLUDER (K970611)Origin Medsystems, Inc.1997-08-19
LACTOSORB TRAUMA PLATING SYSTEM (K971870)Biomet, Inc.1997-08-19
CRYO CHECK APC RESISTANT PLASMA (K971222)Precision Biologicals, Inc.1997-08-19
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR (K972371)Brasamerica Medical Equipment, Inc.1997-08-19
ASSERACHROM TPA TEST KIT (K971519)American Bioproducts Co.1997-08-19
MEDISYSTEMS DIALYSIS PRIMING SETS (K971860)Medisystems Corp.1997-08-18
GUIDELINE SYSTEM (K970943)Axon Instruments, Inc.1997-08-18
ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER (K971500)Biological & Environmental Control Laboratories1997-08-18
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI (K961942)Radionics, Inc.1997-08-18
POTTY PAL AND FOREVER-DRY (K971855)Digital Applications, Inc.1997-08-18
DINAMAP COMPACT MONITOR (K970182)Johnson & Johnson Medical, Inc.1997-08-18
EARCHECK (K971859)Mdi Instruments, Inc.1997-08-18
LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES (K972322)Walter Lorenz Surgical, Inc.1997-08-18
BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM (K972029)Bicon, Inc.1997-08-18
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (K971874)Sharplan Lasers, Inc.1997-08-18
ROOTFORM DENTAL IMPLANT SYSTEM (K954758)Swiss Dental Center1997-08-18
TRACCELL 2000 SLIDE MAPPING SYSTEM (K964689)Accumed Intl., Inc.1997-08-18
BESECURE EXTERNAL URINARY COLLECTION SYSTEM (K971271)Urology Research Intl., Inc.1997-08-18
TULIP (K970129)Richard Ting1997-08-18
V-DELTA 450 (K972683)Metalor Dental USA Corp.1997-08-18
CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM (K965140)Cardio Metrics, Inc.1997-08-18
TDK MEDICAL GRADE CD-R (K971848)Tdk Electronics Corporation of America1997-08-15
MINIMED INFUSION PUMP, MODEL 507C (K972107)Medtronic Minimed1997-08-15
PRINTER INTERFACE (K970305)Micromedical, Inc.1997-08-15
E-READER (K970436)Natural Herbal Products, Inc.1997-08-15
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (K972782)Dade Intl., Inc.1997-08-15
VARIAN RADIATION THERAPY IMAGING SYSTEM (K971839)Varian Medical Systems, Inc.1997-08-15
LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES (K972104)Shinemound Enterprise, Inc.1997-08-15
FULL BODY RESTRAINT SYSTEM (K972046)Gillen Industries1997-08-15
VERA PD SOLDER (K972632)Aalba Dent, Inc.1997-08-15
QUANTIFY(901) (K972710)Hematronix, Inc.1997-08-15
SEALAPEX (K972369)Sybron Dental Specialties, Inc.1997-08-15
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC (K971845)Sound Hearing Instruments, Inc.1997-08-15
CEREC 2 CROWN SOFTWARE (K972276)Siemens AG1997-08-15
SYRINGE NEEDLE REMOVER (S.N.R.) (K972536)Post Medical, Inc.1997-08-15
MEDI-SIS SYRINGE INFUSION SYSTEM (K972173)I-Flow Corp.1997-08-15
SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER (K970348)Siemens Medical Solutions USA, Inc.1997-08-15
AIR CONDUCTION HAEARING AIDS (K971852)Beltone Electronics Corp.1997-08-15
VERA PDN (K972118)Aalba Dent, Inc.1997-08-15
IL TEST IRON (K972363)Instrumentation Laboratory CO1997-08-15
POWDER FREE LATEX EXAMINATION GLOVES (K970115)Pt Mbf Buana Multicorpora1997-08-15
AALBA GOLD SOLDER (K972532)Aalba Dent, Inc.1997-08-15
POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED) (K972838)Absolute Synthetic Technologies Malaysia Sdn. Bhd.1997-08-15
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE (K971937)Terumo Medical Corp.1997-08-15
MEDISYSTEMS PERITONEAL DIALYSIS SETS (K963668)Medisystems Corp.1997-08-15
DEVMED STEPPING AND STABILIZING SYSTEM (K972152)Devmed Corp.1997-08-15
LORIPRO, LORIPRO II (K972058)Lori Medical Laboratories, Inc.1997-08-15
ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM (K972465)Aloka Co., Ltd.1997-08-15
PHONAK NOVO FORTE E3 (K972106)Phonak, Inc.1997-08-15
PASCO MIC AND MIC/ID PANELS (K971951)Pasco Laboratories, Inc.1997-08-15
OXLIFE EXCELL OXYGEN CONCENTRATORS (K971964)Oxlife, Inc.1997-08-15
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) (K964594)Circon Corp.1997-08-15
ENTERAL NUTRITION 1000 ML/500ML (K970849)Medical Infusion Technologies, Inc.1997-08-15
WILSON-COOK NEEDLE KNIFE PAPILLOTOME (K972674)Wilson-Cook Medical, Inc.1997-08-15
TITANIUM SPINAL ROD SYSTEM (K970635)Smith & Nephew, Inc., Orthopaedic Div.1997-08-14
ORTHO DX NEUROMUSCULAR STIMULATOR (K971542)Rehabilicare, Inc.1997-08-14
CONFOSCAN (K971953)Tomey Corporation USA1997-08-14
BK-N SEALING CAP (K971930)Biotronik, Inc.1997-08-14
AQUA SPRAY (K971941)Boyd Industries, Inc.1997-08-14
Cordis Endeavor Infusion Catheter (K972110)Cordis Corp.1997-08-14
A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE (K970388)Biotronik, Inc.1997-08-14
PIVOTING COMPENSATING FILTERS FOR THE HEAD (K972766)Octostop, Inc.1997-08-14
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER (K971879)Continuum Biomedical, Inc.1997-08-14
DEXON VIOLET (K972566)Davis & Geck, Inc.1997-08-14
ELPHA 2000 CONTI (K964738)Dan Med, Inc.1997-08-14
SCULPTURE (K971609)Servizi Medico Estetici Italinai Srl.1997-08-14
TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS (K964176)Tecno Instruments (Usa), Inc.1997-08-14
AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD (K971540)American Biosurgical, Inc.1997-08-14
THE CIRCULATOR BOOT (K971026)Circulator Boot Corp.1997-08-14
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET (K963073)Harmac Medical Products, Inc.1997-08-14
HARMAC THERMODILUTION CATHETER (K963336)Harmac Medical Products, Inc.1997-08-14
ACCU-PULSE CARBON DIOXIDE LASER SYSTEM (K971830)Argus Photonics Group1997-08-14
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Every clearance here is in the API, with alerts when new ones post.