Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS (K873168)Spectramed, Inc.1988-01-12
SWEDE CHAMP (WHEELCHAIR) (K875034)Etac Us, Inc.1988-01-12
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR (K875061)Sherwood Medical Co.1988-01-12
SWEDE PETITE (WHEELCHAIR) (K875035)Etac Us, Inc.1988-01-12
ACUSYST-P/3X (K875151)Endotronics, Inc.1988-01-12
COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750 (K875136)Lakewood Biochemical Co., Inc.1988-01-12
OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT (K874162)Pentron Corp.1988-01-12
DISPOSABLE STERILE SYRINGE FILTERS (K875122)Corning Medical & Scientific1988-01-12
ANGIOMED INTRODUCING SETS (K874771)Angiomed U.S., Inc.1988-01-12
PATTERN DISCRIMINATION PERIMETER (K874336)Lkc Technologies, Inc.1988-01-12
RAICHEM(TM) ALCOHOL REAGENT (K874382)Reagents Applications, Inc.1988-01-11
BILIRUBIN (TOTAL) (K875069)Tech-Co, Inc.1988-01-11
THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. (K874250)Richmond Products, Inc.1988-01-11
REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS (K874626)Syva Co.1988-01-11
FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 (K874624)Cyberfluor, Inc.1988-01-11
QBC BLOOD BANK SYSTEM (K874147)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-11
SUPERVISOR SUN GOGGLES(TM) (K873405)Eye Communications, Inc.1988-01-11
IVT NORTHEAST ALLERGY SCREEN (K874169)In Vitro Technologies, Inc.1988-01-11
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL (K874876)Baxter Healthcare Corp1988-01-11
SOLOS SINGLE USE TITANIUM TIP (K874334)Solos Ophthalmology1988-01-11
WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT (K874251)Richmond Products, Inc.1988-01-11
BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A (K874840)Bennett X-Ray Corp.1988-01-11
FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 (K874621)Cyberfluor, Inc.1988-01-11
SONOLAYER-V, SAL-38B (K872288)Toshiba Medical Systems1988-01-11
PRESSURE LIMIT CONTROL (K874415)Draeger Medical, Inc.1988-01-11
IVT SOUTHEAST ALLERGY SCREEN (K874168)In Vitro Technologies, Inc.1988-01-11
IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (K872942)Clinical Sciences, Inc.1988-01-11
HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. (K872895)Haemonetics Corp.1988-01-11
ALBUMIN, BROMCRESOL GREEN DYE-BINDING (K875070)Tech-Co, Inc.1988-01-11
FLEXIE THE COPPER SHANK NEEDLE (K874891)Skin Deep, Inc.1988-01-07
PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL (K874509)Playtex, Inc.1988-01-07
MULTICHEM HDL PRECIPITATING REAGENT #S0914 (K874820)Simmler, Inc.1988-01-07
CARDIOFAX-V ECG-8110A (K873874)Nihon Kohden America, Inc.1988-01-07
PROXIMAL FEMORAL REPLACEMENT PROSTHESIS (K874575)Dow Corning Wright1988-01-07
DEGANIA SILICONE TOURNIQUET (K875092)Degania Silicone , Ltd.1988-01-07
POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD (K874531)Intermedics, Inc.1988-01-07
INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER (K874296)Ulti-Med Intl., Inc.1988-01-07
ORTHOMET BONE SCREWS (K875050)Orthomet, Inc.1988-01-07
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM (K874809)Biotrol, USA, Inc.1988-01-07
ORTHOMET PIN SYSTEM (K874913)Orthomet, Inc.1988-01-07
IN-THE-EAR HEARING AID (K875009)House of Hearing Aids, Ltd.1988-01-07
ORTHOMET WIRE FOR SUTURE, CERCLAGE (K874919)Orthomet, Inc.1988-01-07
BARD DESAI CATHETER ELECTRODE (K873995)C.R. Bard, Inc.1988-01-07
HISTOBRUSH (K874604)Spectrum Co.1988-01-07
DELTA SCRUB (K872823)Pacific Biosystems, Inc.1988-01-07
MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS (K873158)Tpl-Cordis, Inc.1988-01-07
AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID (K874385)Audiotone, Inc.1988-01-07
MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR (K874523)Mon-A-Therm, Inc.1988-01-06
PALL LEUKOCYTE REMOVAL FILTER, PLATELETS (K873667)Pall Biomedical Products Co.1988-01-06
MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR (K874524)Mon-A-Therm, Inc.1988-01-06
MODIFIED AIRWAY TEMPERATURE SENSOR (K874520)Mon-A-Therm, Inc.1988-01-06
MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH (K872658)Del Mar Avionics1988-01-06
LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH (K872928)Fidelity Medical, Inc.1988-01-06
ULTRASPOT MICROMANIPULATOR (K873443)Cooper Lasersonics, Inc.1988-01-06
RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT (K873748)Deknatel, Inc.1988-01-06
IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP (K873884)Y1988-01-06
DISPOSABLE I.V. ADMINISTRATION SET (K872953)Mac Lee Medical Products1988-01-06
MODEL 3000 INFUSION PUMP (K871881)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-06
MODIFIED THERMAL WELL TEMPERATURE SENSOR (K874521)Mon-A-Therm, Inc.1988-01-06
HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR (K874568)Mallinckrodt Critical Care1988-01-06
MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER (K874930)Intermedics, Inc.1988-01-06
ROPER-TUKE ELBOW (K873660)Orthopedic Systems, Inc.1988-01-06
KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS (K874643)Kirschner Medical Corp.1988-01-06
AUTO SYRINGE MODEL AS20G INFUSION PUMP (K873746)Baxter Healthcare Corp1988-01-06
SET, ADMINISTRATION INTRAVASCULAR (K874467)Kendall Mcgaw Laboratories, Inc.1988-01-06
PALL LEUKOCYTE REMOVAL FILTER, BLOOD (K873666)Pall Biomedical Products Co.1988-01-06
ZEISS VISULAS ARGON LASER (K874609)Carl Zeiss, Inc.1988-01-06
MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR (K874525)Mon-A-Therm, Inc.1988-01-06
REFLOTRON (R) AMYLASE (K874704)Boehringer Mannheim Corp.1988-01-05
THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (K874207)Intl. Remote Imaging Systems1988-01-05
QBC SYSTEM HEMOGLOBIN (K874427)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-05
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) (K873371)Bio-Rad1988-01-05
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM (K874810)Biotrol, USA, Inc.1988-01-05
PROSPECT/GIARDIA (K874849)Alexon Biomedical, Inc.1988-01-05
BETATRON IV SYSTEM (K872774)Cardiac Pacemakers, Inc.1988-01-05
MUG-INDOLE DISC (K874933)Scott Laboratories, Inc.1988-01-05
DC-TROL LEVEL 1 OR 2 (K874772)Diagnostic Chemicals, Ltd. (Usa)1988-01-05
SAKURA DRS-60 AUTOMATIC SLIDE STAINER (K874897)Sakura Finetek U.S.A., Inc.1988-01-05
LUMICON (K873893)Hamilton Co.1988-01-05
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X (K874033)Diagnostic Products Corp.1988-01-05
CELL COUNTING GRID GRATICULE (K874190)Portable Medical Laboratories, Inc.1988-01-05
REVISED LABELING FOR SYVA BARBITURATE ASSAYS (K874702)Syva Co.1988-01-05
PARAMAX URINE/CSF CALIBRATOR (K874587)Baxter Healthcare Corp1988-01-05
BIOTROL BICARBONATE (CO2) UV HP) (K874941)Biotrol, USA, Inc.1988-01-05
BLOOD UREA NITROGEN (K874532)Catachem, Inc.1988-01-05
EBV-EA TEST (K872617)Gull Laboratories, Inc.1988-01-05
PT PRO-CLOT (K874373)Probe-Tek, Inc.1988-01-05
MRI STRETCHER (K874332)Atomic Products Corp.1988-01-05
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY (K874856)Syva Co.1988-01-05
FLUID SAMPLING PACK (K874436)U.S. Mfg. & Management, Inc.1988-01-05
REAGENT A AND REAGENT B (K874413)Seradyn, Inc.1988-01-05
VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (K874367)Spembly Medical , Ltd.1988-01-04
MODIFIED SIMPSON PERIPHERAL ATHEROCATH (K874706)Devices For Vascular Intervention, Inc.1988-01-04
ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. (K872265)Labsonics, Inc.1988-01-04
MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR (K874076)Physio Technology, Inc.1988-01-04
TUNING FORKS (K874966)Solway, Inc.1988-01-04
ENDOSCOPES FOR SINUS SURGERY (K874215)Richards Medical Co., Inc.1988-01-04
KODAK REMOTE ALARM UNIT (K874926)Eastman Kodak Company1988-01-04
NEEDLE CONTAINER (K874430)American Medical Technology, Inc.1988-01-04
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