Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR (K974312)Telemed Systems, Inc.1998-01-21
STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING (K974028)Conceptus, Inc.1998-01-21
STEALTHSTATION SYSTEM (K974187)Surgical Navigation Technologies, Inc.1998-01-21
DEPUY AMK 3 PEG PATELLA (K972643)Depuy, Inc.1998-01-21
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP (K974056)Holopack International, LP1998-01-21
QUEST PET IMAGING SYSTEM (K973396)Ugm Medical Systems, Inc.1998-01-21
DIGITAL TINNITUS MASKING SYSTEM (K974501)Petroff Audio Technologies1998-01-20
MILTRA IMAGING INC., IMAGE VAULT (K974102)Mitra Imaging, Inc.1998-01-20
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED (K972385)Smiths Industries Medical Systems, Inc.1998-01-20
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER (K974567)Hewlett-Packard Co.1998-01-20
ALCON CONTACT LENS CASE (K974281)Alcon Laboratories1998-01-20
VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. (K974077)J. Morita USA, Inc.1998-01-20
KODAK DIGITAL SCIENCE CARDIAC VIEWER (K974086)Eastman Kodak Company1998-01-20
ARGOSY PROGRAMMABLE ONQUE (K974242)Argosy Electronics1998-01-20
TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605 (K972614)Healthdyne Technologies, Inc.1998-01-20
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR (K974018)Wilson-Cook Medical, Inc.1998-01-20
MEDPOR OCULAR CONFORMER (K972034)Porex Surgical, Inc.1998-01-20
PHACOPAK (K974719)Paradigm Medical Industries, Inc.1998-01-20
KERATOME SYSTEM (K974243)Insight Technologies Instruments, LLC1998-01-20
LITE TOUCH ERBIUM LASER TREATMENT SYSTEM (K974460)Lorad Corp.1998-01-16
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT (K972967)Osteonics Corp.1998-01-16
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (K974818)Radiometer America, Inc.1998-01-16
METRON QA-510 SPO2 ANALYZER (K973991)Metron U.S., Inc.1998-01-16
DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET (K970572)Implant Integration Systems, Inc.1998-01-16
REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM (K972242)Medtronic Vascular1998-01-16
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM (K972332)Aesculap, Inc.1998-01-16
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW (K973309)Vilex, Inc.1998-01-16
PDI STERILE LUBRICATING JELLY (K974768)Nice-Pak Products, Inc.1998-01-16
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET (K973633)Atrion Medical Products, Inc.1998-01-16
ADVANTAGE EMG SYSTEM, MODEL #A100 (K974010)Advantage Medical Division of Cme Telemetrix1998-01-16
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM (K974346)Star Medical Technologies, Inc.1998-01-16
RECHARGEABLE BATTERY PART NUMBER GL825-200 (K974061)Alexander Mfg. Co.1998-01-16
SERVOTRONIC EC100 SYSTEM (K972857)Medicon EG1998-01-16
SCANTECH LASER SCANNER (K974633)Phantom Technologies, Inc.1998-01-16
SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK (K973046)General Surgical Innovations1998-01-16
EMBLA (K971813)Ferguson Medical1998-01-16
HOME CARE BEAD BED (K972176)Kinetic Concepts, Inc.1998-01-16
TIMESH SYSTEM (K974017)Sofamor Danek USA,Inc.1998-01-16
BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED (K972562)Electroscope, Inc.1998-01-16
POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE (K973830)Safe Glove , Ltd.1998-01-16
RAC 2A MODULE HOUSING (K973984)Marquette Medical Systems, Inc.1998-01-16
MODEL 37-185 (K973960)Victoreen, Inc.1998-01-14
AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM (K973953)Aktina Medical Physics Corp.1998-01-14
ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K974394)Oxoid , Ltd.1998-01-14
120 LEAF MULTILEAF COLLIMATOR (K973963)Mitsubishi Electronics America, Inc.1998-01-14
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES (K973918)Nihon Kohden America, Inc.1998-01-13
SILICONE ANTIBACTERIAL FOLEY CATHETER (K971627)Rochester Medical Corp.1998-01-13
KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE (K974527)American Institute of Koryo Hand Therapy1998-01-13
MAGLIFE C (K972535)Odam1998-01-13
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS (K974083)Ohmeda Medical1998-01-13
PRIMED SHOE COVERS, PRIMED HEAD COVERS (K971076)Primeline Medical Products, Inc.1998-01-13
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM (K973923)Ebi Electro Biology1998-01-13
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K974644)Johnson & Johnson Clinical Diagnostics, Inc.1998-01-13
JOBST ATHROMBIC PUMP/SLEEVE (K970922)Jobst A Beiersdorf Co.1998-01-13
TRIAGE STATMETER (K973547)Biosite Incorporated1998-01-13
GERMICIDAL CLOTH (K974304)Convatec, A Division of E.R. Squibb & Sons1998-01-13
SINGLE LUMEN EMBOLECTOMY CATHETER (K972572)American Biomed, Inc.1998-01-13
HUBERLOC (K973497)Medcare Medical Group, Inc.1998-01-13
OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS (K974434)Osteonics Corp.1998-01-12
SONOS 5500 IMAGING SYSTEM (K971116)Hewlett-Packard Co.1998-01-12
ENCORE LINEAR HIP (K972791)Encore Orthopedics, Inc.1998-01-12
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM (K973880)Sonix Technologies, Inc.1998-01-12
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE (K974039)Schwartz Electro-Optics, Inc.1998-01-12
SUNGLASSES (K974511)Sun World Intl., Inc.1998-01-12
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS (K974592)Smith & Nephew, Inc.1998-01-12
KRONNER LOW PROFILE SCOPE HOLDER (K973543)Kronner Prototypes, Inc.1998-01-12
LUGE GUIDE WIRE (K973945)Scimed Life Systems, Inc.1998-01-12
ORBITAL RECONSTRUCTION PLATES (K973982)Howmedica, Inc.1998-01-12
ESSENTIAL SHAVER SYSTEM (K974232)Gyrus Ent LLC1998-01-12
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION (K973921)Bausch & Lomb, Inc.1998-01-12
EZ HOLD 1 LBS., EZ HOLD 2 LBS (K973132)Tz Medical, Inc.1998-01-12
VAPR (K974022)Mitek Products1998-01-12
LAPAROSCOPIC GASTROSTOMY KIT (K973891)Applied Medical Resources1998-01-12
ENCORE LINEAR POROUS COATED HIP (K974294)Encore Orthopedics, Inc.1998-01-12
FS IV MINI C-ARM SYSTEM (K974058)Hologic, Inc.1998-01-12
CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) (K970663)Baxter Healthcare Corp1998-01-11
THE HARVARD LIBRARY (K970678)Harvard Apparatus, Inc.1998-01-09
IOTEC TROCAR AND FLEXIBLE CANNULA (K970888)Iotec Industries1998-01-09
SMARTVALVE (K974589)Icu Medical, Inc.1998-01-09
KERR COMPOMER (K974105)Sybron Dental Specialties, Inc.1998-01-09
SNORING CONTROL DEVICE (K963591)Kenneth Hilsen1998-01-09
SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE (K970838)Somnus Medical Technologies, Inc.1998-01-09
RANDOX INORGANIC PHOSPHOROUS (K974605)Randox Laboratories, Ltd.1998-01-09
TINA-QUANT PREALBUMIN (K972638)Boehringer Mannheim Corp.1998-01-09
TINA-QUANT HAPTOGLOBIN (K972639)Boehringer Mannheim Corp.1998-01-09
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES (K974334)Hong Huang Tang Industrial Co., Ltd.1998-01-09
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM (K973584)Medtech Instruments1998-01-09
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING (K974569)Boehringer Mannheim Corp.1998-01-09
BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) (K972747)Propper Mfg. Co., Inc.1998-01-09
MANAN(TM) INTRODUCER SHEATH/NEEDLE (K974815)Medical Device Technologies, Inc.1998-01-09
CODMAN INTRACRANIAL BOLT (K974088)Johnson & Johnson Professionals, Inc.1998-01-09
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY (K972640)Boehringer Mannheim Corp.1998-01-09
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM (K973917)Sims Deltec, Inc.1998-01-09
GLUTATECT (K971888)Alden Scientific, Inc.1998-01-09
SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE (K970837)Somnus Medical Technologies, Inc.1998-01-09
GALLINI ABS DEVICE (K973152)Gallini U.S., LLC1998-01-09
WINGED NEEDLE HOLDER (K974327)Phx Technologies Corp.1998-01-09
LIFE PAK 12 (K973486)Physio-Control Corp.1998-01-09
VTU-E VACUUM ERECTION SYSTEM (K974470)Encore, Inc.1998-01-09
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE (K973884)Frantz Design, Inc.1998-01-09
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