Atlas FDA

1991

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

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RecordFirmDate
DW237 (K904876)Ivoclar North America, Inc.1991-04-17
CATHETER, NASAL, OXYGEN (K902420)Gainor Medical Europe, Ltd.1991-04-17
ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED (K911511)Diagnostic Products Corp.1991-04-17
PATIENT GAS SAMPLING LINE FOR OHMEDA 6000 (K910509)Intertech Resources, Inc.1991-04-17
OXYFRESH OXYCARE 3000 (K910832)Oxyfresh1991-04-17
MOBILE TREATMENT CART (K910243)Jedmed Instrument Co.1991-04-17
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER (K900197)Sound Linked Data, Inc.1991-04-17
PHONAK 9800 SC-AF ITE HEARING INSTRUMENT (K911210)Phonak, Inc.1991-04-17
TRAY DOUGH (K911225)The Hygenic Corp.1991-04-17
ANTIMICROBIAL CEFUROXIME (K911187)Alamar Biosciences Laboratory, Inc.1991-04-17
DRESSER ARGUS P/N 1818 (K905304)Dresser Argus, Inc.1991-04-17
OPUS CMV TEST SYSTEM (K905257)Pb Diagnostic Systems, Inc.1991-04-17
CHLORIDE REAGENT (K911297)Intersect Systems, Inc.1991-04-16
RESPI-PAK RT-PAK (K910452)Cns, Inc.1991-04-16
MASTER FLOW I.V. PUMPETTE (K905497)The Master Medical Corp.1991-04-16
EMISSION TOMOGRAPHY CAROUSEL (K896151)Atf Consolidated1991-04-16
HELENA THROMBOPLASTIN REAGENT WITH DILUENT (K905807)Helena Laboratories1991-04-16
DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP (K903298)Micro Motors, Inc.1991-04-16
CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL (K905457)Consolidated Technologies, Inc.1991-04-16
VIDEO ANNOTATOR MODEL PK2310 (K910384)Perkins Mfg. Co.1991-04-16
MULTIPLE BIOPSY DEVICE-MBX (K911448)Triton Technology, Inc.1991-04-16
REP SPE PLUS (ACID BLUE) SYSTEM (K911468)Helena Laboratories1991-04-16
LATEX EXAMINATION GLOVES (HYPOALLERGENIC) (K911447)Aladan Corp.1991-04-16
Y ADAPTOR (K910321)Akcess Medical Products, Inc.1991-04-16
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION (K910213)Abbott Laboratories1991-04-16
IMMULITE(TM) TOTAL T4 (K910261)Cirrus Diagnostics, Inc.1991-04-16
INPERSOL CAPD BIOCAP ADMINISTRATION SET (K911094)Abbott Laboratories1991-04-16
SAFETYSNAP SAFETY SYRINGE (K910520)U.S. Medical Instruments, Inc.1991-04-16
MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE (K910716)Richard Wolf Medical Instruments Corp.1991-04-16
SHIMADZU IMAGE PROCESSOR DFS-500 (K905132)Shimadzu Medical Systems1991-04-16
STAT 2 IV PUMPETTE (K905498)The Master Medical Corp.1991-04-16
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K (K911339)Shimadzu Medical Systems1991-04-16
OPUS FSH (K911409)Pb Diagnostic Systems, Inc.1991-04-16
PHONAK 9300 SC-AF ITE HEARING INSTRUMENT (K911209)Phonak, Inc.1991-04-15
LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 (K911355)Strato Medical Corp.1991-04-15
ZIRCONIA CERAMIC MODULAR HEADS (K905687)Biomet, Inc.1991-04-15
MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM (K910167)Microbio-Medics, Inc.1991-04-15
AHL, ITE MODEL AMERICAN (K910325)Bob Bare Hearing Aid Repair1991-04-15
TYCERAMIC (K910569)Jeneric/Pentron, Inc.1991-04-15
LUXAR MODEL LX-20 CO2 LASER (K904068)Luxar Corp.1991-04-15
HEMOCARD-AS (K910430)Isolab, Inc.1991-04-15
PERIOGARD(R) PERIOPEN (K901955)Colgate-Palmolive Co.1991-04-15
TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T (K910268)Hitachi Medical Corp.1991-04-15
CVIS INSIGHT IMAGING CATHETER (K904618)Cardiovascular Imaging Systems, Inc.1991-04-12
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS (K904752)Boehringer Mannheim Corp.1991-04-12
DANAM DATACELL-18 (K910283)Danam Electronics1991-04-12
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER (K910633)Yellow Springs Instrument Co., Inc.1991-04-12
LANEX EXAM GLOVES (K910977)Multi M Intl., Inc.1991-04-12
PROPAQ 102, 104 AND 106 (K910772)Protocol Systems, Inc.1991-04-12
ELECTRODE EXTENDER (K905060)Megadyne Medical Products, Inc.1991-04-12
LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYST (K910233)Laser Photonics, Inc.1991-04-12
ANTI-FOG DISPOSABLE IV INDUCTION COVER (K910104)Central Plastic, Inc.1991-04-12
FIXATION PIN (K911452)Simpex, Inc.1991-04-12
OHMEDA - LOW FLOW FLOWMETER (K910316)Ohmeda Medical1991-04-12
CANDELA MINI-UB ENDOSCOPE (K910732)Candela Laser Corp.1991-04-12
BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY (K905643)Agen Biomedical , Ltd.1991-04-12
VISI-STREP (K910537)Kev Connecticut Diagnostics, Inc.1991-04-12
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 (K910639)Em Diagnostic Systems, Inc.1991-04-12
ACCENT DG BALLOON URETERAL DILATOR SET (K905375)Cook Urological, Inc.1991-04-12
INCARE PINSITE DRESSING (K905206)Hollister, Inc.1991-04-12
BC 1206 IMPLANT - INSERT TYPE (K904705)Minimatic Implant Technology1991-04-12
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 (K910640)Em Diagnostic Systems, Inc.1991-04-12
UTAK LABORATORIES TOXICOLOGY CONTROL (K903061)Utak Laboratories, Inc.1991-04-12
CARDIOLAB AMPLIFIER MODULE (CAM) (K910307)Prucka Engineering, Inc.1991-04-12
FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) (K910547)Turnkey Intergration USA, Inc.1991-04-12
ALLDRESS MULTI LAYERED WOUND DRESSING (K910857)Scott Health Care1991-04-12
FLEXMEDICS MALLEABLE CANNULA (K910674)Flexmedics1991-04-12
ADVANCE 418(TM) (K904984)Peripheral Systems Group1991-04-12
LH IRMA IMMUNOMAG (K911050)Pantex, Div. Bio-Analysis, Inc.1991-04-12
ILC FORCEPS PADS (K905583)Inman Liebelt Corp.1991-04-12
FIXATION WIRE (K911505)Simpex, Inc.1991-04-12
H-TRON V 100 INSULIN INFUSION PUMP (K905693)Disetronic Medical Systems1991-04-12
MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002 (K905372)Bio-Feedback Systems, Inc.1991-04-12
CHALLENGE (TM) LIQ THERA DRUG CONTROLS (K910333)Medical Analysis Systems, Inc.1991-04-12
SYNCHRON C-REACTIVE PROTEIN REAGENT (K910535)Beckman Instruments, Inc.1991-04-12
DEFIBRILLATOR LEAD ADAPTER (K905065)Spacelabs, Inc.1991-04-12
EBV IGG ELISA TEST (K910872)Gull Laboratories, Inc.1991-04-12
HBO CABLE ASSEMBLY, RADIOMETER TC-02 (K905225)Sechrist1991-04-10
RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 (K903020)Aequitron Medical, Inc.1991-04-10
MENTOR EEG SYSTEM (K904763)Oxford Medilog, Inc.1991-04-10
OPTICAL FRAME (K910179)Australian Optical Co., Inc.1991-04-10
MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER (K900557)Monaghan Medical Corp.1991-04-10
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS (K910707)Jedmed Instrument Co.1991-04-10
BACTERIA FILTER (K904830)Vital Signs, Inc.1991-04-10
MINIATURE TEMPERATURE TRAINER MODEL DT-002 (K905373)Bio-Feedback Systems, Inc.1991-04-10
LOW VISION ENHANCEMENT SYSTEM (LVES) (K910124)Triangle Investments1991-04-10
SMT-50X (K905634)Shimadzu Medical Systems1991-04-10
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD (K910107)Baxter Healthcare Corp1991-04-10
MICROTEST MULTI MICROBE MEDIUM (K910526)Microtest1991-04-09
YSI PRECISION 4000 THERMOMETER (K910718)Yellow Springs Instrument Co., Inc.1991-04-09
OSCAR(TM) II CAPNOMETER & PULSE OXIMETER (K904843)Dalton Instrument Corp.1991-04-09
OPTI-PLAST 5F PTA CATHETERS (K910996)Vas-Cath, Inc.1991-04-09
MODEL 5866-46 SLEEVE KIT (K910568)Medtronic Vascular1991-04-09
HAEMODIALYSIS CONCENTRATE (K904946)Bdh, Inc.1991-04-09
RENAFLO HDF 1350 HEMODIAFILTER (K910236)Minntech Corp.1991-04-09
BCD ADVANCED (K910923)Shiley, Inc.1991-04-09
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES (K905288)Med-Tek Innovations, Inc.1991-04-09
BARD(R) SYRINGE ASSIST IRRIGATION (K905102)C.R. Bard, Inc.1991-04-09
MEDI-TECH BALLOON DILATATION CATHETER (K910995)Boston Scientific Corp1991-04-09
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST (K910215)Cd Medical, Inc.1991-04-09
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Every clearance here is in the API, with alerts when new ones post.