Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
HELICAL SCAN (K910375)Toshiba America Medical Systems, In.C1991-03-15
GDC-3200 DENTAL SOLDER (K910065)Deringer-Ney, Inc.1991-03-15
STERAID DISPOSABLE SYRINGE (K904620)Disposable Medi-Aids , Ltd.1991-03-15
DYNATRON 200 MICROCURRENT (K903577)Dynatronics Corp.1991-03-15
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM (K905728)Hewlett-Packard Co.1991-03-15
KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP (K902193)Kevtek Medical Products, Inc.1991-03-15
MOTOR DRIVEN EXTIRPATION INSTRUMENTS (K904859)Aesculap, Inc.1991-03-15
MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL (K905032)Parkell1991-03-15
VIAL ACCESS CANNULA (K905664)Baxter Healthcare Corp1991-03-15
ITE HEARING AID (K905371)Audicare Hearing Center1991-03-15
7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS (K910529)Siemens Ultrasound, Inc.1991-03-15
ENAMEL ETCHING GEL (K910803)Gresco Products, Inc.1991-03-15
IONOSEAL (K905723)Micro-Vac, Inc.1991-03-15
OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT) (K910134)Kentucky Optical Co.1991-03-15
INTEGO (K910904)Racal Health & Safety, Inc.1991-03-15
BALLOON CATHETERS (K904669)Olympus Corp.1991-03-15
WIRON 99 DENTAL CASTING ALLOY (K903538)Leach and Dillon Co., Inc.1991-03-15
BC-1201 CAST ABUTMENT (K904703)Minimatic Implant Technology1991-03-15
ACETATE CONCENTRATES FOR HEMODIALYSIS (K905021)Medical Components, Inc.1991-03-15
KRUPIN EYE VALVE WITH DISK (K905703)Hood Laboratories1991-03-15
FLOSCOPE VASCULAR LAB. (K905157)Advance Medical Device, Inc.1991-03-15
LACRIMAL PLUG (K905750)Tamcenan Corp.1991-03-14
EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE (K910527)Syva Co.1991-03-14
SUNGLASSES/NON-PRESCRIPTION (LA GIARDINIERA) (K910125)The Limited Stores, Inc.1991-03-14
SUNGLASSES (NON-PRESCRIPTION) (K905864)The Limited Stores, Inc.1991-03-14
FORCE 10, 20, 30, AND 40 (K905605)Valleylab, Inc.1991-03-14
HOWMEDICA HNR SYSTEM (K903563)Howmedica Corp.1991-03-14
ACE RECONSTRUCTIVE PLATE (K905595)Ace Medical Co.1991-03-14
SUNGLASSES, NON-PRESCRIPTION (ITALO CREMONA) (K910126)The Limited Stores, Inc.1991-03-14
SUNGLASSES, NON-PRESCRIPTION (POLINELLI) (K910127)The Limited Stores, Inc.1991-03-14
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE (K905482)Pfizer Hospital Products Group, Inc.1991-03-14
SUTURE APPLIER DEVICE (K905722)Laparomed Corp.1991-03-14
TRABECULO-SUPRACHOROIDAL SHUNT (K902296)Visionex, Inc.1991-03-14
INFANT REFLUX SLING (K905630)Pedicraft, Inc.1991-03-13
MANHANDLER (K905381)Lifeport, Inc.1991-03-13
MICROLINE SCREEN FOR OPIATES (K905491)Drug Screening Systems, Inc.1991-03-13
ON-SITE ALCOHOL (K903223)Toxi-Lab, Inc.1991-03-13
PEDICRAFT INFANT REFLUX WEDGE (K905629)Pedicraft, Inc.1991-03-13
SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT (K905289)Medical Engineering Corp.1991-03-13
VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM (K910005)Med Institute, Inc.1991-03-13
MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA (K910335)Medical Technical Products1991-03-13
3M MODEL 8240 ITE HEARING AID (K910690)3M Company1991-03-13
RENALYZER PRX 90 (K903034)Swedish Trade Council USA1991-03-13
DENTRONIX MODEL 2000 (K910202)Dentronix, Inc.1991-03-13
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY (K904329)Baxter Healthcare Corp1991-03-12
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION (K905179)Syva Co.1991-03-12
SEMINOR (K905764)Promedex, Inc.1991-03-12
SUNGLASSES (K910329)Cutler & Gross Sloan Optical , Ltd.1991-03-12
BACT/ALERT (TM) (K903505)Organon Teknika Corp.1991-03-12
TVS II ELECTRONIC INCENTIVE SPIROMETER (K910138)Monaghan Medical Corp.1991-03-12
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO (K905580)Exactech, Inc.1991-03-12
CIBA CORNING ACS FERRITIN IMMUNOASSAY (K905770)Ciba Corning Diagnostics Corp.1991-03-12
EDLICH WOUND MANAGEMENT TRAY (K905572)Sorex Medical1991-03-12
KODAK X-OMAT MULTILOADER 300 (K905607)Eastman Kodak Company1991-03-12
EXACTECH HUMERAL SHOULDER PROSTHESIS (K905577)Exactech, Inc.1991-03-12
SPIROLOOP, MODIFICATION (K904633)Pneumedics, Inc.1991-03-12
Q SYSTEM 28 HIP STEM (K910010)Turnkey Intergration USA, Inc.1991-03-12
BIODEGRADABLE SURGICAL STAPLE (K910723)Instrument Makar, Inc.1991-03-12
NEXT WAVE(R) PHYSIOACCOUSTIC(TM) CHAIR (K905256)Next Wave, Inc.1991-03-12
RETAINER, SCREW EXPANSION ORTHODONTIC (K903498)Masel Industries, Inc.1991-03-12
STERILE SURGEON'S GLOVES (K902449)Unigloves , Ltd.1991-03-12
EXTERNAL FETAL MONITOR TRANSDUCER HOLDER (K905606)Atheus Corp.1991-03-12
POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK (K910082)Quidel Corp.1991-03-12
ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE (K902766)Advanced Ischemia Recorders, Inc.1991-03-12
LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS (K905542)Lares Research, Inc.1991-03-11
ANTIGENZ CHLAMYDIA (K905402)Northumbria Biologicals , Ltd.1991-03-11
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS (K910085)Roche Diagnostic Systems, Inc.1991-03-11
ABUSCREEN(R) ONLINE CONTROLS (K910689)Roche Diagnostic Systems, Inc.1991-03-11
CHEMA CHOL CHOLESTEROL SYSTEM (K904031)Texas Intl. Laboratories, Inc.1991-03-11
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 (K910638)Em Diagnostic Systems, Inc.1991-03-11
HEMOCARD CONTROL (K910431)Isolab, Inc.1991-03-11
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000) (K910756)Roche Diagnostic Systems, Inc.1991-03-11
LARES APOLLO CS/CP/C (K905543)Lares Research, Inc.1991-03-11
LOOP RETRIEVER (K910603)Annex Medical, Inc.1991-03-11
BACTEC NR-860 (K910835)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-03-11
NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST (K905596)Neuromed, Inc.1991-03-11
BIOTROL LACTATE DEHYDROGENASE (L-P) (K905683)Biotrol, USA, Inc.1991-03-11
CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED (K910147)Olympus Corp.1991-03-11
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS (K905496)Meadox Medicals, Div. Boston Scientific Corp.1991-03-11
SIEMENS ETCO2 CARTRIDGE (K905775)Siemens Medical Electronics1991-03-11
GLUCOSE (HK) REAGENT, UNIVERSAL (K905227)Enzyme Technology, Inc.1991-03-11
PVC VINYL GLOVE (K910891)Pioneer Sundries Products , Ltd.1991-03-11
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K910484)Alamar1991-03-11
CCC CROWN-CORE-CUT-NEEDLE (K905557)Uni-Quatro Industries Canada, Inc.1991-03-08
HIGH SPEED CORE CUT BIOPSY GUN (K905556)Uni-Quatro Industries Canada, Inc.1991-03-08
543 SERIES BTE (K905680)Hearing Tech, Inc.1991-03-08
NON-STERILE PATIENT EXAMINATION GLOVES (K905755)Superior Healthcare Group, Inc.1991-03-08
POST AURICULAR HEARING AID MODEL PICO SC-H (K910028)Phonak, Inc.1991-03-08
PHILIPS GYROVIEW-HR IMAGING WORKSTATION (K905603)Philips Medical Systems, Inc.1991-03-08
MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (K910471)Baxter Healthcare Corp1991-03-08
EVIDENCE BIOLOGICAL INDICATOR (K910417)Skyland Scientific Services, Inc.1991-03-08
PATIENT EXAMINATION GLOVES (K904697)Shamrock Marketing Co.1991-03-08
IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) (K901975)Savyon Diagnostics , Ltd.1991-03-08
SYSNPAR PORCELAIN (K910303)Jeneric/Pentron, Inc.1991-03-08
STRATOFUSE PCA INFUSER (K905696)Strato Medical Corp.1991-03-08
MAMEX DC AMI SL12/MG15 (K905748)Soredex, Inc.1991-03-07
STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE (K901883)Stereotactic Image Systems, Inc.1991-03-07
ANTERIOR NECK CONTOUR COIL (K905512)Magnetic Research, Inc.1991-03-07
BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD (K902588)Gambro-Hospal, Inc.1991-03-07
BODY COMPOSITION ANALYZER (K904970)Body Composition Analog, Inc.1991-03-07
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Track 1991 automatically

Every clearance here is in the API, with alerts when new ones post.