Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MICROGUIDE LESION MARKING SYSTEM (K923120)Angiodynamics, Div. E-Z-Em, Inc.1992-09-01
COMPOSITE RESIN CORE PASTE MATERIAL (K921174)Centrix, Inc.1992-09-01
CONTINUUM KNEE SYSTEM (K920080)Techmedica, Inc.1992-09-01
LITE FIL II A (K920892)Shofu Dental Corp.1992-09-01
DEROYAL EYE DRESSING (K923300)Deroyal Industries, Inc.1992-09-01
LUKENS 2-0 BRAIDED SILK SUTURES (K922254)Quinton, Inc.1992-09-01
STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT (K921010)Apm Stern Gold1992-09-01
SHOWERFLOSS (K923457)Summit Marketing Group, Inc.1992-09-01
WALLSTENT ESOPHAGEAL PROTHESIS (K923119)Schneider U.S. Stent Div.1992-09-01
SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD (K923090)Ryan Medical, Inc.1992-09-01
CERAMIC FEMORAL HEAD (K920593)Dow Corning Wright1992-08-31
OPTHALMIC FRAMES (K922687)Optique Forte , Ltd.1992-08-31
MODIFIED SITE MACROBORE PHACO NEEDLE (K922595)Chiron Vision Corp.1992-08-31
OHMEDA MODEL 5250 RGM MONITOR (K920590)Ohmeda Medical1992-08-31
THERMA-H (K921189)Zewa AG1992-08-31
CUTINOVA FOAM (K922681)Jobst Institute, Inc.1992-08-31
AWOS ANGIOGRAPHIC WORKSTATION (K922804)Siemens Medical Solutions USA, Inc.1992-08-28
ABL50 BLOOD GAS SYSTEM (K922922)Radiometer America, Inc.1992-08-28
NEURAY SURGICAL PATTIES AND STRIPS (K923027)Martland Healthcare, Inc.1992-08-28
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE (K920281)Trinity Laboratories, Inc.1992-08-27
FISSURE SEALER (K913853)Ortho Source1992-08-27
MONAD NUCLEAR IMAGING SYSTEM (K923044)Trionix Research Laboratory, Inc.1992-08-27
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR (K920338)Puritan Bennett Corp.1992-08-27
ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE (K922991)Abbott Laboratories1992-08-27
ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102 (K905434)Nobelpharma USA, Inc.1992-08-27
Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL (K923202)Jeneric/Pentron, Inc.1992-08-27
TRACHEOSTOMY CARE KIT (K921281)Trinity Laboratories, Inc.1992-08-27
GLENROE GOLDEN ORTHODONTIC BRACKET (K923124)Glenroe1992-08-27
SILON TRANSPARENT WOUND DRESSINGS (K923150)Bio Med Sciences, Inc.1992-08-27
SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R (K921425)Acoma Medical Imaging, Inc.1992-08-27
AP-6CR CINERADIOGRAPHIC FILM PROCESSOR (K915365)The Allen Products Co.1992-08-27
RUBELLA IGM (K921573)Clark Laboratories, Inc.1992-08-27
BARD STONE REMOVAL BALLOON CATHETER (K920342)C.R. Bard, Inc.1992-08-26
CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA (K922941)Clinical Neuro Systems, LLC1992-08-26
RUBBER FRAME SUNGLASSES (K922508)Jedda Dist., Inc.1992-08-26
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM (K914188)Ortho Diagnostic Systems, Inc.1992-08-26
MEYER FOREIGN BODY LOCATOR (K920470)Seymour W. Meyer1992-08-26
BIOSPSY FORCEPS (K920762)Symbiosis Corp.1992-08-26
KODAK INSIGHT PORTABLE IMAGING SYSTEM (K921826)Eastman Kodak Company1992-08-26
ISOTRON III (K921954)Excel Tech. , Ltd.1992-08-26
PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS (K921178)Medical Associated Services, Inc.1992-08-26
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS (K912837)Kirschner Medical Corp.1992-08-26
CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE (K922936)Clinical Neuro Systems, LLC1992-08-26
STARKEY SM SERIES BTE HEARING AIDS (K923784)Starkey Laboratories, Inc.1992-08-26
MULTI III (K921953)Excel Tech. , Ltd.1992-08-26
ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED (K912364)Hitachi Medical Corp. of America1992-08-26
PLATELET AGGREGATION REAGENTS (K922800)Chrono-Log Corp.1992-08-26
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT (K923569)Baxter Diagnostics, Inc.1992-08-26
THE CLEANER ACCESSORY (K921882)Eaton Medical Corp.1992-08-25
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL (K923317)Helena Laboratories1992-08-25
CYTOLOGY BRUSH (K922851)Annex Medical, Inc.1992-08-25
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL (K923318)Helena Laboratories1992-08-25
DISPOSABLE INTUBATION KITS (K921077)Coast Medical Corp.1992-08-25
LOOP RETRIEVER (K922678)Annex Medical, Inc.1992-08-25
MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K923010)Hitachi Medical Systems America, Inc.1992-08-25
FLLYNN(R) GENESIS AC (K913039)O-Two Systems Intl., Inc.1992-08-25
FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER (K921697)Abbott Laboratories1992-08-25
BARD MARLEX MESH DART (K922916)C.R. Bard, Inc.1992-08-24
MODEL 105 VENTILATOR, MODIFICATION (K922477)Infrasonics Corp.1992-08-24
USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT (K920980)C.R. Bard, Inc.1992-08-24
TEC ROTATING DUAL HEMOVALVE (K912664)Intensive Technology, Inc.1992-08-24
STANDARD IMAGING HDR 1000 ION CHAMBER (K922554)Standard Imaging, Inc.1992-08-24
TOUCH N' HEAT, MODIFICATION (K921604)Analytic Technology1992-08-24
MILES POTASSIUM METHOD (K923038)Heraeus Kulzer, Inc.1992-08-24
QUADRATURE SHOULDER CONTOUR COIL (K920227)Magnetic Research, Inc.1992-08-24
PATIENT CONTROLLED SYRINGE PUMP TYPE 3300 (K915270)Graseby Medical , Ltd.1992-08-24
GAC THUMB-SUCKING CONTROL APPLIANCE (K920850)Gac Intl., Inc.1992-08-24
MILES URINE CREATININE METHOD (K923039)Heraeus Kulzer, Inc.1992-08-24
SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER (K922492)Specialty Packaging Producs, Inc.1992-08-24
DIGOXIN COATED TUBE RIA (K922353)Monobind1992-08-24
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS (K922913)Syva Co.1992-08-24
AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY (K923314)Serex, Inc.1992-08-24
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000 (K922411)Eastman Kodak Company1992-08-24
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT (K922915)Syva Co.1992-08-24
COWBOY II (K920308)Kinetic Concepts, Inc.1992-08-24
VOICEWAVE (K923924)Personal Sound Technologies, Inc.1992-08-24
GROUP AUDITORY TRAINING SYSTEM (K922720)Phonic Ear, Inc.1992-08-24
EMIT 2000 PROCAINAMIDE CALIBRATORS (K922914)Syva Co.1992-08-24
WOUND DRESSING (K922540)Les Laboratorires Brothier, S.A.1992-08-24
PERMAMESH HYDROXYLAPATITE MATRIX (K921468)Ceramed Corp.1992-08-21
DOSCOPE AND ACESSORIES (K920224)Applied Laparoscopy1992-08-21
PULPDENT HARD CORE (K922755)Pulpdent Corp.1992-08-20
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM (K914959)Ciba Corning Diagnostics Corp.1992-08-20
IMAGICA MICRO-ENDOSCOPE (K921393)Fiberoptic Medical Products, Inc.1992-08-20
DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT (K922680)E.I. Dupont DE Nemours & Co., Inc.1992-08-20
BIOSTARS STREP A OIA -- MODIFICATION (K922765)Biosearch Medical Products, Inc.1992-08-20
AL-ACID GLYCOPROTEIN RID KIT (K922417)The Binding Site, Ltd.1992-08-20
MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM (K920212)Shared Systems, Inc.1992-08-20
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K922780)Alamar Biosciences Laboratory, Inc.1992-08-20
STC DIAGNOSTICS AUTO-LYTE OPIATE EIA (K921328)Solarcare Technologies Corp,Inc.1992-08-20
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST (K920401)General Biometrics, Inc.1992-08-20
COMFIT STERILE LATEX EXAMINATION GLOVE (K922513)Wembley Rubber Products (M) Sdn Bhd1992-08-20
WAKO IGG-HA (K923070)Wako Chemicals USA, Inc.1992-08-20
STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA (K921140)Solarcare Technologies Corp,Inc.1992-08-20
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. (K922700)E.I. Dupont DE Nemours & Co., Inc.1992-08-20
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST (K920400)General Biometrics, Inc.1992-08-20
VISTA HPQ SYSTEM (K920714)Philips Medical Systems (Cleveland), Inc.1992-08-20
GUIDEWIRES, VARIOUS TYPES (K920884)Acme-Monaco Corp.1992-08-19
ARRAY(R) 360 (K922273)Beckman Instruments, Inc.1992-08-19
ANTIMICROBIAL SUSCETIBILITY TEST PANEL (K922003)Alamar Biosciences Laboratory, Inc.1992-08-19
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Every clearance here is in the API, with alerts when new ones post.