Atlas FDA

1997

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

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RecordFirmDate
ESTEEM 1.5T MRI SYSTEM (K972826)Elscint Mr, Inc.1997-10-15
(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI (K972807)Benz Research and Development Corp.1997-10-15
PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM (K972973)Perception, Inc.1997-10-15
PORS ON LITE (K972910)Degussa Corp.1997-10-14
SERVO VENTILATOR 300A (K970839)Siemens Elema AB1997-10-14
LORI/LORI, LORI-S (LORI STOCK AID) (K973376)Lori Medical Laboratories, Inc.1997-10-14
TONGUE KLEAN (K973175)Softek Ent.1997-10-14
ABC LINEARITY VERIFIERS (K973790)Sc Calibrators & Controls, LLC1997-10-14
CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES (K972762)Cardio Metrics, Inc.1997-10-14
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER (K971501)Bio-Logic Systems Corp.1997-10-14
VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER (K972686)Smv America1997-10-14
ABC CALIBRATION VERIFIERS (K973791)Sc Calibrators & Controls, LLC1997-10-14
OSTEOMED QUICKFIX (K962774)Osteomed Corp.1997-10-10
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (K972684)Innerdyne, Inc.1997-10-10
INSULATOR WIRE GUIDE (K972977)Cook Urological, Inc.1997-10-10
PLATALLOY (K972607)Aalba Dent, Inc.1997-10-10
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K972799)Dade Microscan, Inc.1997-10-10
LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K973488)Oxoid , Ltd.1997-10-10
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (K973157)Pointe Scientific, Inc.,1997-10-10
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM (K972796)Sigma Diagnostics, Inc.1997-10-10
STORZ MILLENNIUM VISCOUS FLUID SYSTEM (K972664)Storz Instrument Co.1997-10-10
LUBRIGLIDE (K973557)Qualis, Inc.1997-10-10
LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K973489)Oxoid , Ltd.1997-10-10
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) (K971628)Somanetics Corp.1997-10-10
GALILEO HIGH RESOLUTION MICRO COUPLER (K971896)Netoptix Corp.1997-10-10
AUTOMIX 3+3/AS COMPOUNDER SYSTEM (K961008)Baxter Healthcare Corp1997-10-10
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (K972964)Atrion Medical Products, Inc.1997-10-10
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS (K965112)Medline Industries, Inc.1997-10-10
ACCUMETER THEOPHYLLINE TEST (K972495)Chemtrak, Inc.1997-10-10
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE (K964056)Rusch Intl.1997-10-10
PACER MODEL 100 INFUSION CONTROLLER (K963136)Health Watch, Inc.1997-10-10
ELECSYS DIGOXIN (K973112)Boehringer Mannheim Corp.1997-10-10
CBALK-1000 BLADE (K972727)Howard Instruments, Inc.1997-10-10
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER (K972823)A & A Medical, Inc.1997-10-10
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON (K973075)Roche Diagnostic Systems, Inc.1997-10-09
RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE (K971281)Medcomp1997-10-09
MAGO AUTOMATED EIA PROCESSOR (K973177)Diamedix Corp.1997-10-09
MULTITAK SS SUTURE SYSTEM (K973015)Bonutti Research1997-10-09
DUAL OFFSET PERFECTA IMC HIP STEM (K972641)Wrightmedicaltechnologyinc1997-10-09
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR (K972130)Fairmontmedical1997-10-09
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR (K964434)Skylark Device Co., Ltd.1997-10-09
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) (K971858)Sigma Diagnostics, Inc.1997-10-09
DEPUY AE TK2 HIP SCREW SYSTEM (K972629)Depuy, Inc.1997-10-09
MRI COMPATIBLE BIOPSY NEEDLES (K962977)Manan Medical Products, Inc.1997-10-09
CRE BALLOON DILATATION CATHETER (K971320)Boston Scientific Corp1997-10-09
UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) (K973418)Assembly Required Dist., Inc.1997-10-09
STRAIGHT-IN BONE SCREW FIXATION SYSTEM (K972622)Influence, Inc.1997-10-09
GLUCOTREND BASIC SYSTEM (K972876)Boehringer Mannheim Corp.1997-10-09
GAMMA LOCKING NAIL SYSTEM (K972813)Howmedica Corp.1997-10-09
TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE (K973062)Medidenta Intl., Inc.1997-10-09
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (K972726)Medical Packaging Corp.1997-10-08
GELBFISH ENDO-VAC SYSTEM (K970233)Gary A. Gelbfish1997-10-08
MAMMOLOADER BY C.M.A. SRL (K973125)C.M.A.1997-10-08
LIQUID LDH-L REAGENT SET (K973589)Pointe Scientific, Inc.,1997-10-08
DISSECTRON PORTABLE UNIT (K972612)Satelec1997-10-08
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (K972986)Boston Biomedica, Inc.1997-10-08
INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF (K971273)Bio-Tek Instruments, Inc.1997-10-08
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE (K972926)KARL STORZ Endoscopy-America, Inc.1997-10-08
E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION (K972569)Nsk Nakanishi, Inc.1997-10-08
ROTOGRAPH PLUS (K972968)Chicago X-Ray Systems, Inc.1997-10-08
DRTS IMAGE INTENSIFIER DRAPE (K973073)Minrad, Inc.1997-10-08
DAR-3000B (K973342)Shimadzu Corp.1997-10-08
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT (K972815)Grace Medical, Inc.1997-10-08
VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K (K972922)Interview Medical Technology Corp.1997-10-08
ACU-RAY HF SERIES PORTABLE X-RAY UNIT (K972204)Sterne Equipment Co., Ltd.1997-10-08
AMBER DU (K973219)Oldelft Corp. of America1997-10-08
CM & CM DS-7 (K963914)Konica Medical Corp.1997-10-08
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX (K973329)Shimadzu Medical Systems1997-10-08
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH (K973327)Shimadzu Medical Systems1997-10-08
COEUR 130 ML ANGIOGRAPHIC SYRINGE (K971712)Coeur Laboratories, Inc.1997-10-08
MANIFOLD (K972654)Medical Specialties Intl., Inc.1997-10-08
LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR (K971877)Dideco S.P.A.1997-10-08
DEY VIAL SODIUM CHLORIDE 3% (K972778)Dey Laboratories, Inc.1997-10-08
MD100 & MM150 (K963913)Konica Medical Corp.1997-10-08
PLA-96P (K973086)Southern Dental Industries, Inc.1997-10-07
TACTYLON CONDOM (K971590)Sensicon Corp.1997-10-07
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB (K972825)Cordis Corp.1997-10-07
PRECINORM RF, PRECIPATH RF (K973629)Boehringer Mannheim Corp.1997-10-07
RUSCH BRILLANT BALLOON CATHETER (K971643)Rusch Intl.1997-10-07
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS (K972678)Mcgaw, Inc.1997-10-07
BIPOLAR SCISSORS (K972558)Enable Medical Corp.1997-10-07
TOKUSO REBASE MR. BOND (K973245)Tokuyama America, Inc.1997-10-07
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) (K972847)Eastman Kodak Company1997-10-07
HOWMEDICA FULLY THREADED SCREWS (K972811)Howmedica Corp.1997-10-06
NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY (K972561)American Laser Medical1997-10-06
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I (K973126)Biosite Incorporated1997-10-06
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (K973367)Radiometer America, Inc.1997-10-06
CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K973487)Oxoid , Ltd.1997-10-06
2487 DUAL WAVELENGTH ABSORBANCE DETECTOR (K973074)Waters Corporation1997-10-06
REAADS PROTEIN C ANTIGEN TEST KIT (K972342)Reaads Medical Products, Inc.1997-10-06
ACCUWELL T4-EIA (K972974)Neometrics, Inc.1997-10-06
MYOGLOBIN CONTROL SET (K973358)Boehringer Mannheim Corp.1997-10-06
LASEREX LP1532 PHOTOCOAGULATOR (K972514)Ellex Medical Pty, Ltd.1997-10-03
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE (K972169)Pwa Industries Sdn. Bhd.1997-10-03
VTU-1 VACUUM ERECTION SYSTEM (K971257)Mckenna & Cuneo1997-10-03
PLS-96P (K973088)Southern Dental Industries, Inc.1997-10-03
INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY) (K971947)Sim Italia S.R.L.1997-10-03
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING (K973389)Ventana Medical Systems, Inc.1997-10-03
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR (K971131)Fukuda Denshi USA, Inc.1997-10-03
AIA-PACK IGE II ASSAY (K972697)Tosoh Medics, Inc.1997-10-03
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Every clearance here is in the API, with alerts when new ones post.