Atlas FDA

1990

4,721 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SEAL RITE(TM) (K902022)Pulpdent Corp.1990-07-20
SURG-K SURGICAL KERATOMETER (K901553)The Sanborn Co.1990-07-20
I3SYSTEM-ABD (K902007)Innovative Imaging, Inc.1990-07-20
URETHRAL CATHETER TRAY (LATEX) (K901184)Orion Life Systems, Inc.1990-07-20
FOLEY CATHETER INSERTION TRAY (30CC) (K901180)Orion Life Systems, Inc.1990-07-20
EPC ELECTRONIC PIPETTING SYSTEM (K902592)Ulster Scientific, Inc.1990-07-19
BILIRUBIN CONTROL (K902616)Phoenix Diagnostics, Inc.1990-07-19
ASPEN 3 OXYGEN CONCENTRATOR (K902890)Mountain Medical Equipment, Inc.1990-07-19
GENESYS 6000 GAMMA COUNTER (K900087)Laboratory Technologies, Inc.1990-07-19
EMIT(R) II BARBITURATE ASSAY (K902580)Syva Co.1990-07-19
IONOMETER EH-F AND ACCESSORIES (K901040)Fresenius USA, Inc.1990-07-19
LIGHT, HEAD, EXAMINATION (K901706)Burton Medical Products Corp.1990-07-19
ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER (K902344)Ati1990-07-19
BLOOD GAS/ISE CONTROLS (K902094)Phoenix Diagnostics, Inc.1990-07-19
STERI-VAC GAS STERILIZER MODEL 5XL (K902036)3M Company1990-07-19
MODELS 4201, 4231 & 4235 EXTENSION CABLES (K902679)Pace Medical1990-07-19
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II) (K902257)Codman & Shurtleff, Inc.1990-07-19
FLEXIBLE EXTENDER (K902035)Beacon Laboratories, Inc.1990-07-19
SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT (K902719)Labeltape Meditect, Inc.1990-07-19
BILATERAL TMJ COIL (K902630)Resonex, Inc.1990-07-19
ANGIOGRAPHY DRAPE PACK (K902293)Biocor Medical, Inc.1990-07-19
TOY SUNGLASSES (K901802)Sirco Intl. Corp.1990-07-19
METRICARE ENTERAL FEEDING SYSTEM (K895923)Metrix Co.1990-07-19
ISOFLO(TM) HIGH PRESSURE INJECTION LINES (K901382)Healthdyne Cardiovascular, Inc.1990-07-19
EXEL HUBER INFUSION SET (K895770)Exel Intl.1990-07-19
BIURET (COLORMETRIC), TOTAL PROTEIN (K901527)American Research Products Co.1990-07-19
BECTON DICKINSON 360 INFUSER (TM) SYSTEM (K902409)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-07-19
EASY BREATHER MODEL 100 ACCESSORIES (K902300)Progressive Productions , Ltd.1990-07-19
TRACHEAL TUBE STYLET (K902180)Sims Surgical, Inc.1990-07-19
DECIDENT (K896364)Nevin Laboratories, Inc.1990-07-19
AFFINITY PROLACTIN TEST SYSTEM (K902698)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-07-19
IMPRAFLO AUTOTRANSFUSION DEVICE (K901232)Impra, Inc.1990-07-18
DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES (K900664)Sterimed, Inc.1990-07-18
PAG MICROPROCESSOR-CONTROLLED MODULE (K900365)Life Sciences Manufacturing, Inc.1990-07-18
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) (K901819)Hewlett-Packard Co.1990-07-18
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT (K902590)Marquette Electronics, Inc.1990-07-18
CWD/PPG MODULE (K896500)Life Sciences Manufacturing, Inc.1990-07-18
RED DOT 2269 INFANT MONITORING ELECTRODE (K902080)3M Company1990-07-18
ZEPPELIN INSTRUMENTS (K902850)Ruggles Corp.1990-07-18
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE (K901555)Medtronic Vascular1990-07-18
COBE CLOSED WOUND DRAINAGE KIT (K902759)Cobe Laboratories, Inc.1990-07-18
VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE (K900451)Pace Tech, Inc.1990-07-18
MDI ADAPTOR (K900783)Hudson Oxygen Therapy Sales Co.1990-07-18
CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR (K902114)Diemolding Corp.1990-07-18
LOW FLOW N2O/02O MICROBLENDER (K900722)Bird Products Corp.1990-07-18
HYDRO-SIL(TM) COATED GUIDEWIRES (K900822)National-Standard Medical Products1990-07-17
LEOCOR CORFLO(TM) PUMP (K900350)Leocor, Inc.1990-07-17
ARTERIAL EMBOLECTOMY CATHETER (K900311)Impra, Inc.1990-07-17
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) (K884120)S & W Medico Teknik1990-07-17
MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT (K902194)Immunotech Corp.1990-07-17
CARDISUNY 501AB (K901947)Graham-Field, Inc.1990-07-17
FOCUS J81F, J83F, J41F, J43F PACING LEADS (K896742)Ela Medical, Inc.1990-07-17
BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT (K902801)Beckman Instruments, Inc.1990-07-17
CARDISUNY 501BIII (K901948)Graham-Field, Inc.1990-07-17
PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM (K901762)Automatic Liquid Packaging, Inc.1990-07-17
LVM QUALITY CONTROL SERUM (K902235)Ciba Corning Diagnostics Corp.1990-07-17
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T (K902147)Pacesetter Systems1990-07-17
TECHNICON RA-2000(TM) SYSTEM (K901410)Technicon Instruments Corp.1990-07-17
TRANS-PACE 100 (K900220)Synchromed Corp.1990-07-17
OPTI-RAY SUNGLASSES (K902414)Opti-Ray, Inc.1990-07-17
MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER (K900460)Novoste Corp.1990-07-17
MODIFIED OVUGEN (K902208)Biogenex Laboratories1990-07-17
FUKUDA DENSHI MODEL HJ-310 (K901889)Fukuda Denshi USA, Inc.1990-07-17
CALCIUM:ARSENAZO III (K902476)Amresco, Inc.1990-07-17
COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER (K902671)Cobe Laboratories, Inc.1990-07-17
CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM (K900247)Colin Medical Instruments Corp.1990-07-17
TRAM PATIENT MONITOR (K900540)Marquette Electronics, Inc.1990-07-17
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT (K902560)Roche Diagnostic Systems, Inc.1990-07-17
CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 (K902479)Amresco, Inc.1990-07-17
PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A (K895520)Hewlett-Packard Co.1990-07-17
SMALL VESSEL BALLOON DILATATION CATHETER (K897124)Boston Scientific Corp1990-07-17
HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND (K902673)Hi Chem, Inc.1990-07-17
PASCO MIC AND MIC/ID MODIFIED (K902739)Pasco Laboratories, Inc.1990-07-16
CODMAN SUCTION PATTIE (K901937)Codman & Shurtleff, Inc.1990-07-16
MEADOX SURGIMED BIOPSY GUN AND NEEDLE (K902461)Meadox Surgimed, Inc.1990-07-16
CLOSED DISCONNECT SYSTEM (K900106)Delmed, Inc.1990-07-16
ABBOTT LIFECARE 4100 PCA INFUSER (K895710)Abbott Laboratories1990-07-16
ACID PHOSPHATASE REAGENT SET (K902495)Tech Intl. Co.1990-07-16
PTH-MM II 125I RADIOIMMUNOASSAY (RIA) (K901711)Incstar Corp.1990-07-16
GASTROINTESTINAL CYTOLOGY BRUSH (K901435)Telemed Systems, Inc.1990-07-16
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT (K902261)Ambu, Inc.1990-07-16
WILSON-COOK ESOPHAGEAL MOTILITY CATHETER (K900239)Wilson-Cook Medical, Inc.1990-07-16
CHEM-CHEX BILIRUBIN (K902867)Streck Laboratories, Inc.1990-07-16
MODIFIED FLOCATH PULMONARY ARTERY CATHETER (K901733)Cardio Metrics, Inc.1990-07-16
BAG, URINE (K902417)Gainor Medical Europe, Ltd.1990-07-16
1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT) (K900577)Intertech Resources, Inc.1990-07-16
DMAC INDOLE REAGENT (K902640)Api Analytab Products1990-07-16
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) (K902356)Eastman Kodak Company1990-07-16
SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY) (K902699)Actio, Inc.1990-07-16
OLYMPIC BILI-LITE-PAD(TM) (K901987)Olympic Medical Corp.1990-07-16
SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET (K902773)Medical Engineering Corp.1990-07-16
CARDS O.S. MONO (K902510)Pacific Biotech, Inc.1990-07-16
WILSON-COOK SYRINGE HOLDERS (K902107)Wilson-Cook Medical, Inc.1990-07-16
CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275) (K901630)Henley Intl.1990-07-16
UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE (K902897)United Biotech, Inc.1990-07-16
ANAEROBIC ACCU-CULSHURE(TM) (K901645)Medical Laboratory Automation Systems, Inc.1990-07-16
GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER (K900918)Gambro, Inc.1990-07-16
DENDIA WERK BURS AND CUTTING DISCS (K901967)Micro-Aire Surgical Instruments, Inc.1990-07-13
THIN CONDOM RAMSES & SHEIK (K897140)Schmid Laboratories, Inc.1990-07-13
SIEMENS SONOLINE AC (K896480)Siemens Medical Solutions USA, Inc.1990-07-13
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Every clearance here is in the API, with alerts when new ones post.