Atlas FDA

1992

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

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RecordFirmDate
THE BELTONE AUDIO SCOUT (K915323)Beltone Electronics Corp.1992-05-11
BIOMEDICAL HORIZONS MODEL 1001 (K921369)Biomedical Horizons, Inc.1992-05-11
KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER (K921055)Kendall Healthcare Products Co. Div.Of Tyco Health1992-05-11
DAB DETECTION KIT (K920600)Ventana Medical Systems, Inc.1992-05-11
SUTURE REMOVAL KIT, STERILE, DISPOSABLE (K920280)Trinity Laboratories, Inc.1992-05-11
HIGH VAC (K920492)Hygoplastic, Inc.1992-05-11
CAMBRIDGE PC/GXT STRESS TEST SYSTEM (K921331)Health Watch, Inc.1992-05-11
LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE (K921656)Siemens Hearing Instruments, Inc.1992-05-08
DURAFUSE INFUSION PUMP (K920773)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-05-08
AEC DETECTION KIT (K920566)Ventana Medical Systems, Inc.1992-05-08
DESERET(R) FLOW RESTRICTION VALVE (K914180)Becton Dickinson Vascular Access, Inc.1992-05-08
DISINFECTION WITH THE COX DRY HEAT STERILIZER (K910925)Cox Sterile Products, Inc.1992-05-08
RHYTHMSCAN PRECISION 6000 (K914577)Precision Health Care Systems, Inc.1992-05-08
STERILIZATION BAG, POLYESTER/WRAP (K915477)Cgs Supplies Corp.1992-05-08
AZITHROMYCIN, 15 MCG, SENSI DISC (K921420)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-05-08
ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT (K914887)Mallinckrodt Medical1992-05-08
H WAVE MUSCLE STIMULATOR (K915230)Electronic Waveform Laboratory, Inc.1992-05-08
RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET (K915109)Ballard Medical Products1992-05-08
INTERFERENTIAL STIMULATOR MODEL INF 4150/A (K921441)Biomedical Life Systems, Inc.1992-05-08
180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. (K920582)Site Microsurgical Systems, Inc.1992-05-08
KEMTROL SERUM CONTROL-ABNORMAL (K920926)Helena Laboratories1992-05-07
SYNERMED ALT/GPT REAGENT KIT (K921016)Synermed, Inc.1992-05-07
IMX INSULIN (K920109)Abbott Laboratories1992-05-07
ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION (K921488)Surgical Technologies, Inc.1992-05-07
MIRCO ELISA HPL TEST KIT (K921212)Bio Clinic Co.1992-05-07
TRIAL LENS SET (K920571)R.H. Burton Co.1992-05-07
NOW PREGNANCY TEST KIT (K921211)Bio Clinic Co.1992-05-07
DOBBHOFF BIPOLAR ADAPTER (K921029)Biosearch Medical Products, Inc.1992-05-06
CHOLANGIOGRAM CATHETER KIT (K920236)Mccol Medical,Inc.1992-05-06
CHOLANGIOLAPCATH(TM) (K921091)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-05-06
ULTRA-THIN (K920547)Boston Scientific Corp1992-05-06
FLOWERS MEDIAL MALAR IMPLANT (K921582)Implantech Associates, Inc.1992-05-06
LAPAROSCOPIC SUCTION/IRRIGATION PROBE (K920643)O.R. Concepts, Inc.1992-05-06
ENTRAC URETHRAL BALLOON DILATATION CATHETER (K920711)American Medical Systems, Inc.1992-05-06
STRETCH WRAP (K915446)Sun Glitz Corp.1992-05-06
VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS (K914991)Coherent Medical Group1992-05-06
MAXAQUIN (K921282)Difco Laboratories, Inc.1992-05-06
BRINK PRE-MAXILLARY IMPLANT (K921580)Implantech Associates, Inc.1992-05-06
M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION) (K921472)Microtest1992-05-06
KONICA LI 10 AND 10A LASER IMAGER (K920769)Konica Corp.1992-05-06
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR (K914190)United States Surgical, A Division of Tyco Healthc1992-05-06
CHIN WAFER (K921581)Implantech Associates, Inc.1992-05-06
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09 (K914836)Omron Healthcare, Inc.1992-05-06
MANUAL SURGICAL INSTRUMENTS (K920263)Phoenix Instruments Div.1992-05-06
BUD MAXILLOFACIAL IMPLANT SYSTEM (K913688)Bud Industries, Inc.1992-05-05
CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT (K921464)Trinity Laboratories, Inc.1992-05-05
BTP(TM) CENTRALINE(TM) SUIT (K914615)Btp Industries, Inc.1992-05-05
E-Z GOLD TOOTH FILLING MATERIAL (K915507)Lloyd Baum Center, Inc.1992-05-05
GDC 3367 (K920922)Deringer-Ney, Inc.1992-05-05
MINIDAM (K921117)Delsan Dental Systems1992-05-05
SCALPEL BLADE REMOVER (BLADEGARD) (K915119)Intergrated Visual, Inc.1992-05-05
TELETOM(R) (K921626)Berchtold Holding GmbH1992-05-05
THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II (K921245)Ormco Corp.1992-05-05
SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA (K912145)S & W Medico Teknik1992-05-05
THE SELBY SYSTEM (K920102)Advanced Spine Fixation Systems, Inc.1992-05-05
SIDESTREAM DRUG NEBULIZER (K914152)Medic-Aid , Ltd.1992-05-05
INSERTION (K920515)Accurate Surgical Instruments Co.1992-05-04
ATRAUMATIC STANDARD SPROTTE NEEDLE (K911202)Pajunk GmbH1992-05-04
REGAL MOTORIZIED 3 WHEELED VEHICLE (K921647)Bruno Independent Living Aids, Inc.1992-05-04
JACE MODEL PM-410 HAND CPM DEVICE (K921351)Jace Systems, Inc.1992-05-04
AIR MEDICA III (K920710)Hinatawada Seimitsu Mfg. Co., Ltd.1992-05-04
CAPTIA CMV-TA (K915479)Mercia Diagnostics , Ltd.1992-05-04
RUBALEX, MODIFICATION (K912391)Orion Corp.1992-05-04
AMPHETAMINES EIA TEST (K921554)Diagnostic Reagents, Inc.1992-05-04
MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI (K915896)Dynatech Laboratories, Inc.1992-05-04
AMBULATOR (K921752)The Anthros Medical Group1992-05-04
ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A (K915210)Biomedical Life Systems, Inc.1992-05-04
BRUNO ELECTRA-RIDE STAIR-WAY ELEVATOR SYSTEM (K921648)Bruno Independent Living Aids, Inc.1992-05-04
CHAGAS' IGG ELISA TEST (K911233)Gull Laboratories, Inc.1992-05-04
SANI-TIP (K920499)Dw Industries, Inc.1992-05-03
SUN/SPORTGLASSES (K920211)Bacou USA, Inc. and Uvex Safety, Inc.1992-05-01
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM) (K914856)Cook, Inc.1992-05-01
THROMBIN CLOTTING TIME REAGENT (K920147)Helena Laboratories1992-05-01
MITEK ANCHOR, MITEK ANCHOR II (K920213)Mitek Surgical Products, Inc.1992-05-01
YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU (K914256)Intl. Remote Imaging Systems1992-05-01
PFF-1 (K914205)Cybermedic, Inc.1992-05-01
KODAK X-OMAT MODEL 180 LP PROCESSOR (K921269)Eastman Kodak Company1992-05-01
CONCEPT ENDOSTEAL FIXATION DEVICE (K912640)Concept, Inc.1992-05-01
HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION (K914620)Vitalog Monitoring,Inc.1992-05-01
CAMINO VENTRICULAR NEEDLE (K920088)Camino Laboratories, Inc.1992-05-01
AUTOSTAT(TM) ANTI-DSNA (K913342)Cogent Diagnotics , Ltd.1992-05-01
SUNGLASSES (K920169)Walgreen Co.1992-05-01
RIONET HEARING AID HB-52S (K921829)Authorized Hearing Systems, Inc.1992-04-29
B-D INTERLINK SYRINGE CANNULA (K920422)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-29
SURGICAL INSTRUMENT STAND (K921210)Murphy Medical Center1992-04-29
VACUTAINER(R) BRAND SST(R) AND CAT TUBES (K921806)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-29
PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS (K920378)Gen-Probe, Inc.1992-04-29
ROCHE COBAS MIRA PLUS (K920402)Roche Diagnostic Systems, Inc.1992-04-29
HAZEL II (K921768)Kinetic Concepts, Inc.1992-04-29
ZB-860PA MULTIPARAMETER TRANSMITTER (K913117)Nihon Kohden America, Inc.1992-04-29
MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES (K915502)Medline1992-04-29
AUTOLOADER (K921005)Innovative Medical Systems, Inc.1992-04-29
PUPLDENT ETCH N PREP (K920485)Pulpdent Corp.1992-04-29
ENZYGNOST(R) TOXOPLASMOSIS/IGG (K913731)Behring Diagnostics, Inc.1992-04-29
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD (K921455)E.I. Dupont DE Nemours & Co., Inc.1992-04-29
TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS (K914362)Acorn Group, Inc.1992-04-29
CRITSPIN MICRO-HEMATOCRIT (K920759)Stat-Spin Technologies1992-04-29
DRAKE & DRAKE/200 DL (K921467)Am Scooters1992-04-29
ELECTRODE, ION SPECIFIC (K915675)Alko Diagnostic Corp.1992-04-29
ZIPPIE P500 (K920179)Sunrise Medical Quickie Designs, Inc.1992-04-29
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Every clearance here is in the API, with alerts when new ones post.