Atlas FDA

1996

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

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RecordFirmDate
PATIENT PROTECTIVE LIMB (K962626)Kenad SG Medical, Inc.1996-10-02
ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) (K962745)Prepared Media Laboratory, Inc.1996-10-02
SUPERSTAND STAND-UP WHELLCHAIR (K962278)The Standing Co., Inc.1996-10-02
PRESSUREGUARD: SELECTCARE (K960188)Span-America Medical Systems, Inc.1996-10-02
STERIMASTER AUTOCLAVE (K944036)Scican1996-10-02
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM (K963200)Wrightmedicaltechnologyinc1996-10-02
EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE (K953983)Richard Wolf Medical Instruments Corp.1996-10-02
FLEXIFLO POLYG GASTOSTOMY TUBE (K963113)Abbott Laboratories1996-10-02
EAGLE PATIENT MONITOR (K960418)Marquette Electronics, Inc.1996-10-02
NULIFE (K962837)Med-Tech Rubber & Engineering Industries1996-10-02
PHACOSCOPE (K960811)Saint John'S Plaza Medical Group1996-10-02
ULTIUM SPINAL PLATING SYSTEM (K962784)Smith & Nephew, Inc., Orthopaedic Div.1996-10-02
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR (K961000)Terumo Medical Corp.1996-10-02
TIBIAL INSERT (K963028)Encore Orthopedics, Inc.1996-10-01
B. BRAUN GUIDEWIRES (K961107)B.Braun Medical, Inc.1996-10-01
FLEXLENS(METHAFILCON A) (K962000)Flexlens, Inc.1996-10-01
AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM (K961304)Exactech, Inc.1996-10-01
INTRA-ORAL THERMOPLASTIC SHIELD (K962622)Medtec, Inc.1996-10-01
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500) (K962923)Depuy, Inc.1996-10-01
PRECISION UV (VASURFILCON A) (K961299)Pilkington Barnes-Hind, Ltd.1996-10-01
INTERMOORE FRACTURE HIP STEM (MODIFY) (K963155)Intermedics Orthopedics1996-10-01
MLI MODULAR STAPLE (K962705)Medicinelodge, Inc.1996-10-01
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER (K962823)Synthes (Usa)1996-10-01
PRESS-FIT FLARED SHELL (K960633)Encore Orthopedics, Inc.1996-10-01
COTREL-DUBOUSSET (CD) SPINAL (K955807)Sofamor Danek USA,Inc.1996-10-01
MITEK MICRO ANCHOR (K962793)Mitek Products1996-10-01
TBD (K963077)Acu Med, Inc.1996-10-01
INFANT WARMER SYSTEM (K963058)Ohmeda Medical1996-10-01
PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER (K962695)Sims Deltec, Inc.1996-10-01
MANUAL PHENYLALANINE TEST (K963040)Bio-Rad1996-10-01
ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER (K962804)Vistakon, Johnson & Johnson Vision Products, Inc.1996-10-01
MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER (K955846)Y1996-10-01
RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT (K962957)Wesley Jessen Corp.1996-10-01
HEELBO BLAZER SLEEVED JACKET (K963243)Heelbo, Inc.1996-10-01
EVIDENCE PREGNANCY TEST (K962721)Saliva Diagnostic Systems1996-10-01
FLEXLENS (K961943)Flexlens, Inc.1996-10-01
BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 (K963585)Diagnostic Ultrasound Corp.1996-10-01
HYUNJAE DENTAL IMPRESSION MATERIALS (K962680)Hyunjae Corp.1996-09-30
KARL STORZ MODEL 203210 O1 UNIMAT PLUS (K962090)KARL STORZ Endoscopy-America, Inc.1996-09-30
IDEAS' DUAL PORT (K962751)Ideas For Medicine, Inc.1996-09-30
S-52 ELECTRONIC VIDEO LAPAROSCOPE (K962651)Del Medical Systems Corp.1996-09-30
VARELISA ANA (4) PROFILE (K963291)Elias U.S.A., Inc.1996-09-30
ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR (K960301)Del Medical Systems Corp.1996-09-30
SIGMA DIAGNOSTICS CREATININE REAGENT KIT (K963534)Sigma Diagnostics, Inc.1996-09-30
PULPDENT ENDODONTIC POST CEMENT KIT (K962747)Pulpdent Corp.1996-09-30
ORLAU SWIVEL WALKER (K923880)Mopac, Ltd.1996-09-30
HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM (K962858)Heartport, Inc.1996-09-30
VIRTUOSO SMART CPAP SYSTEM (K953930)Respironics, Inc.1996-09-30
MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 (K960055)Pudenz-Schulte Medical Research Corp.1996-09-30
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES (K962867)Sensititre Alamar1996-09-30
IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES (K962360)Scimedx Corp.1996-09-30
HWA-TO ACUPUNCTURE NEEDLES (K963299)Lhasa Medical, Inc.1996-09-30
MAGLIFE (K950264)Odam1996-09-27
ROCHE UNIMATE FRUCTOSAMINE REAGENT (K961674)Roche Diagnostic Systems, Inc.1996-09-27
DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION (K963604)Midwest City Hearing Aid Center1996-09-27
DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM (K962613)Gulmay Medical , Ltd.1996-09-27
EBI THERMAL THERAPY SYSTEM (K963261)Electro-Biology, Inc.1996-09-27
EUROLINE A-675 SERIS (K963519)Starkey Laboratories, Inc.1996-09-27
MENTOR INJECTION PORT DETECTOR (IPD) (K963066)Mentor Corp.1996-09-27
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT (K962033)Nichols Institute Diagnostics1996-09-27
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K963080)Bayer Corp.1996-09-27
DCA 2000 + MICROALBUMIN/CREATININE ASSAY (K963142)Bayer Corp.1996-09-27
CUSTOMED BLOOD EXTRACTION KIT (K962596)Customed, Inc.1996-09-27
OHMEDA 7900 ANESTHESIA VENTILATOR (K960964)Ohmeda Medical1996-09-27
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION (K953044)Biotronik, Inc.1996-09-27
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER (K963540)Sigma Diagnostics, Inc.1996-09-27
QUALITROL ANA CONTROL SERUM SET (K961815)Consolidated Technologies, Inc.1996-09-27
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (K962890)Trace Scientific , Ltd.1996-09-27
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT (K963542)Sigma Diagnostics, Inc.1996-09-27
PATRIOT (K963037)Infimed, Inc.1996-09-27
QUANTEX IGG (K962202)Instrumentation Laboratory CO1996-09-26
DISPENS-O-DISC MEROPENEM (K963508)Difco Laboratories, Inc.1996-09-26
EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03 (K960902)Eureduc1996-09-26
QUANTEX C4 (K962198)Instrumentation Laboratory CO1996-09-26
MT-X (K961387)The Emerging Technologies Group1996-09-25
QUANTEX IGM (K962201)Instrumentation Laboratory CO1996-09-25
MT-2 (K961384)The Emerging Technologies Group1996-09-25
J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP (K962757)J.B.S., S.A.1996-09-25
EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM (K962552)Biodynamic Technologies, Inc.1996-09-25
TARGIS SYSTEM (K962878)Ivoclar North America, Inc.1996-09-25
IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS (K962927)Siemens Medical Solutions USA, Inc.1996-09-25
QUANTEX IGA (K962200)Instrumentation Laboratory CO1996-09-25
INCSTAR 25-HYDROXYVITMIN D 1251 RIA (K953567)Incstar Corp.1996-09-25
QUANTEX C3 (K962199)Instrumentation Laboratory CO1996-09-25
ANKLE CALF EXERCISER PHLEBOPUMP (K952975)Prevent Products, Inc.1996-09-25
MT1 (K961383)The Emerging Technologies Group1996-09-25
MT1A (K961382)The Emerging Technologies Group1996-09-25
S-53 INTRORAL DENTAL SYSTEM (K962979)Del Medical Systems Corp.1996-09-25
AUTO SUTURE SURGIWAND (K961771)United States Surgical, A Division of Tyco Healthc1996-09-25
SUPRACONDYLAR INTRAMEDULLARY NAIL (K962561)Zimmer, Inc.1996-09-25
MT-2A (K961386)The Emerging Technologies Group1996-09-25
MT-3A (K961385)The Emerging Technologies Group1996-09-25
QUALITROL RF CONTROLS (K961545)Consolidated Technologies, Inc.1996-09-24
HEMOCUE B-HEMOGLOBIN SYSTEM (K961312)Hemocue, Inc.1996-09-24
AXSYM RUBELLA IGG ANTIBODY ASSAY (K954045)Abbott Laboratories1996-09-24
AIR MOTOR HANDPIECE TN-102 (K962542)Nsk Nakanishi, Inc.1996-09-24
AMD HOME HEALTH MONITORING SYSTEM (K960337)Advanced Medical Devices, Inc.1996-09-24
QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 (K961544)Consolidated Technologies, Inc.1996-09-24
QUALITROL MONO CONTROL SERUM SET (K961550)Consolidated Technologies, Inc.1996-09-24
INSUFFLATION NEEDLE (K963359)Applied Medical Resources1996-09-24
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Every clearance here is in the API, with alerts when new ones post.