Atlas FDA

1997

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

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RecordFirmDate
KENLOR H. PYLORI CONTROL SERUM (K964014)Kenlor Industries, Inc.1997-03-03
SYNERMED ISE REAGENTS (K962479)Synermed, Inc.1997-03-03
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS (K964871)Biosearch Medical Products, Inc.1997-03-03
THYROID STIMULATING HORMONE METHOD (K970393)Dade Chemistry Systems, Inc.1997-03-03
CANON TX-10 TONOMETER (K963079)Canon USA, Inc.1997-03-03
RADIACARE ORAL WOUND RINSE (K964852)Carrington Laboratories, Inc.1997-03-03
IMZ 2000 INTERLOCK 12/3 - SCREW (K963522)Imz, GmbH1997-03-03
IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM (K963495)Imz, GmbH1997-03-03
LEGIONELLA IGG/IGM ELISA TEST SYSTEM (K963318)Armkel, LLC1997-03-03
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN (K964863)Bell Intl., Inc.1997-02-28
CARDIACMONITOR (K963375)Vision Electronics1997-02-28
HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II (K964888)Tz Medical, Inc.1997-02-28
MOBILE MEDICAL MONITOR (M3(A)) (K963576)Scientific Applications1997-02-28
SPINE-TECH BONE HARVESTER (K970040)Spine-Tech, Inc.1997-02-28
DELTA (K945117)Pelton & Crane Co.1997-02-28
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST (K963654)Syntron Bioresearch, Inc.1997-02-28
BIPOLAR SUCTION COAGULATOR (K965241)Kirwan Surgical Products, Inc.1997-02-28
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (K963120)Marquette Electronics, Inc.1997-02-28
STRYKER SAPHENOUS VEIN HARVEST SCOPE (K964930)Stryker Endoscopy1997-02-28
SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET (K964876)Vlv Associates, Inc.1997-02-28
MEDNEXT SURGICAL BUR (K970023)Mednext, Inc.1997-02-28
CYBERLASE CO2 LASER SYSTEM (K964353)Nidek, Inc.1997-02-28
GLOBAL TAPER SPECTRON HIP STEMS (K970351)Smith & Nephew, Inc., Orthopaedic Div.1997-02-28
INTRAMEDULLARY NAIL SYSTEM (K965098)Zimmer, Inc.1997-02-28
THERA-MIST NEBULIZER MODEL-P3000 (K962534)Pegasus Research Corp.1997-02-28
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM (K953076)Sofamor Danek USA,Inc.1997-02-28
HANSSON PIN SYSTEM (K964893)Osteonics Corp.1997-02-28
HA GLOBAL TAPER (GT) TAPERED HIP STEM (K970337)Smith & Nephew, Inc., Orthopaedic Div.1997-02-28
ISOCAM II (DUAL HEAD GAMMA CAMERA) (K964834)Park Medical Systems, Inc.1997-02-28
MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A (K964820)Us Asia Instruments, Inc.1997-02-28
OSTEONICS SCREW HOLE PLUGS (K965056)Osteonics Corp.1997-02-28
AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) (K960309)Airsep Corp.1997-02-28
3M QUIKPLUS SYSTEM (K970168)3M Company1997-02-27
BERGEN 610 BIPOLAR COAGULATOR (K964736)Bergen Mfg.1997-02-27
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW (K965073)Smith & Nephew, Inc.1997-02-27
ARGI-SATIN OR OPTI0-STAR (K965216)Argen Precious Metals, Inc.1997-02-27
BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN (K962666)Bemiss-Jason Corp., Triad Medical Div.1997-02-27
NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING (K964847)Ningbo Yujiang Plastic & Rubber Co. , Ltd.1997-02-27
SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS (K970567)Intermedics Orthopedics1997-02-27
MR EXTENSION SET (001) (K964968)University of Michigan1997-02-27
JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING (K964845)Jinhua Latex Products Factory1997-02-27
ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) (K970039)Medtrex, Inc.1997-02-26
UHE COLLIMATOR (210591) (K963406)Philips Medical Systems (Cleveland), Inc.1997-02-26
BERENSTEIN COIL (K964112)Target Therapeutics1997-02-26
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: (K964813)Medical Advances, Inc.1997-02-26
POLYFIN EXTENSION SET, MODELS 126 AND 128 (K965208)Medtronic Minimed1997-02-26
LIFESHIELD BLUNT CANNULA (K963351)Abbott Laboratories1997-02-26
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) (K964990)Hitachi Medical Systems America, Inc.1997-02-26
PHACOILLUMINATOR - FIBEROPTIC SLEEVE (K964018)Michael Reynard, M.D.1997-02-26
SPETEMP (K964808)Ultradent Products, Inc.1997-02-26
AHS OMEGA SP (K970057)Authorized Hearing Systems, Inc.1997-02-26
SPONGETRAC (K964181)Surgitrac Corp.1997-02-26
MODELS IDA-2 PLUS AND IPT-1 (K961862)Bio-Tek Instruments, Inc.1997-02-26
VIPOR UNIT (K964322)Tilane Corp.1997-02-26
SHE-LI TENS STIMULATOR MODEL SL-101 RX (K961809)Medi Consultants, Inc.1997-02-26
PM 2002 CC PROLINE (K970263)Planmeca Oy1997-02-26
GALILEO EVOKED POTENTIALRE (K963662)Biosound, Inc.1997-02-26
BARD DIRECTOR GUIDEWIRE (000560) (K964780)C.R. Bard, Inc.1997-02-26
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE (K970297)Omni Sales Corp.1997-02-25
NON-PRESCRIPTION SUNGLASSES (K965021)Victory Eyewear Co., Ltd.1997-02-25
HOLLISTER RETRACTED PENIS POUCH (K970443)Hollister, Inc.1997-02-25
SUTURE LOCK (K964935)Smith & Nephew Endoscopy, Inc.1997-02-25
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (K970126)Bio-Rad Laboratories, Inc.1997-02-25
SUNGLASSES (NON-PRESCRIPTION) (K964943)Micron Eyewear Manufactory Co., Ltd.1997-02-25
ENDOCARE MONOPOLAR ELECTRODE (K965118)Endocare, Inc.1997-02-25
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER (K964850)Baxter Healthcare Corp1997-02-25
ENDOCARE ELECTROSURGICAL ELECTRODE (K965243)Endocare, Inc.1997-02-25
CAPIOX SP PUMP HEAD (K962981)Terumo Medical Corp.1997-02-25
DISPOSABLE APRON (K964364)Instrument Makar, Inc.1997-02-25
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS (K964142)Medline Industries, Inc.1997-02-25
LIFECORE CONICAL ABUTMENT (K965135)Lifecore Biomedical, Inc.1997-02-25
EZTEST (K963841)Sgm Biotech, Inc.1997-02-25
THREADLOC DENTAL IMPLANT SYSTEMS (K964768)Sulzer Calcitek, Inc.1997-02-25
RESPIFLO (K962872)Tyco Healthcare Deutschaland GmbH1997-02-25
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (K970281)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-25
GENZYME DIAGNOSTICS CONTRAST MONO (K963425)Genzyme Diagnostics1997-02-25
MEDRAD CONTRAST HOLDER (K964782)Medrad, Inc.1997-02-25
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT (K963917)Holden Walker Corp.1997-02-25
PERFECTIM (K964692)J. Morita USA, Inc.1997-02-25
MASK SURGICAL (K963568)The Innovative Approach, Corp.1997-02-25
RESPIFLO/S (K962874)Curtin & Associates International , Inc.1997-02-25
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM (K963970)Endocare, Inc.1997-02-25
IAMIN IMPREGNATED GAUZE DRESSING (K965005)Procyte Corp.1997-02-24
INNOVASIVE DEVICES ROTATOR CUFF FASTNER (K964945)Innovasive Devices, Inc.1997-02-24
INTERMITTENT COMPRESSOR SYSTEM (K964957)Eischoco, Inc.1997-02-24
KINEMAX PLUS TIBIAL SPACERS (K964951)Howmedica Corp.1997-02-24
COHORT DISCECTOMY SYSTEMS (CDS) (K964975)Cohort Medical Products Group, Inc.1997-02-24
CHLAMYDIA IGG ELISA TEST SYSTEM (K962558)Armkel, LLC1997-02-24
HI-STAR MRI IMAGING SYSTEM (K964778)Health Images, Inc.1997-02-24
KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER (K964752)Philips Medical Systems (Cleveland), Inc.1997-02-24
MITEK ABSORBABLE TOGGLE ANCHOR (K964013)Mitek Products1997-02-24
ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) (K962827)Marquette Electronics, Inc.1997-02-24
CARETONE II (K963678)American Telecare, Inc.1997-02-24
DENTEMP ONE STEP (K964773)Majestic Drug Co., Inc.1997-02-21
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR (K964770)Ge Medical Systems Information Technologies1997-02-21
CERALAS DIODE LASER SYSTEM (CERALAS D2) (K964751)Ceram Optec, Inc.1997-02-21
SPYGLASS ANGIOGRAPHIC CATHETER (K965249)Daig Corp.1997-02-21
9000 SERIES FILTER & FILTER/HME (K963053)Enternet Medical, Inc.1997-02-21
CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS) (K962765)Cordis Corp.1997-02-21
RHEO DOPPLEX II (RD 2) (K964699)Huntleigh Technology, Inc.1997-02-21
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Every clearance here is in the API, with alerts when new ones post.