Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SURG-A-STAT LOOP TIP 2 (K840387)Suncoast Medical Manufacturers, Inc.1984-07-23
SURG-A-STAT LOOP TIP 15 (K840375)Suncoast Medical Manufacturers, Inc.1984-07-23
TEMP. & GSR BIOFEEDBACK DEVICE (K842023)Electronics Research & Production1984-07-20
CA2000 (K842611)Nicolet Biomedical Instruments1984-07-20
CEFONICID 30 MCG SENSI-DISC (K842252)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-07-20
BECTEC NR-660 BACTERIAL DETECT SYS (K842279)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-07-20
GNC PLUS (K842587)Vitek Systems, Inc.1984-07-20
EEG BIOFEEDBACK DEVICE (K842022)Electronics Research & Production1984-07-20
MINIMUM ESSENTIAL MED. M0769 W/WO (K842672)Sigma Chemical Co.1984-07-20
VACUPULSE VACUUM UNIT (K842268)I-Rep, Inc.1984-07-20
COMPACT AUDITORY (K842612)Nicolet Biomedical Instruments1984-07-20
CRITIKON TRIPLE-LUMEN CENTRAL VENOUS (K842316)Critikon Company, LLC1984-07-20
NEW JERSEY ACETABULAR COMPONENT & (K842202)Endomedics, Inc.1984-07-20
SICKLE CELL REAGENT SET (K842368)Livonia Diagnostics, Inc.1984-07-20
CHESEBROUGH-POND'S REUSABLE URINARY LEG (K842553)Chesebrough-Pond'S U.S.A. Co.1984-07-20
BASAL MED. EAGLE B8265, W/EARLS SALTS (K842671)Sigma Chemical Co.1984-07-20
EMERSON MOTION BED 6-MS & 6-ME (K842604)J. H. Emerson Co.1984-07-20
GENERAL DIAG. CEFONICID 30MCG ANTIMIC (K842307)General Diagnostics1984-07-20
CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT (K842151)Bartels Immunodiagnostic Supplies, Inc.1984-07-20
NEW JERSEY FEMORAL STEM (K842234)Endomedics, Inc.1984-07-20
COMPACT VISUAL (K842613)Nicolet Biomedical Instruments1984-07-20
GLUCOSE ASSAY KIT-HEXOKINASE (K842510)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
BENT WINGED MINI-VOL INFUSION SET (K842143)Med Fusion Systems, Inc.1984-07-20
LACTATE DEHYDROGENASE ASSAY KIT (K842507)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
EEG BIOFEEDBACK DEVICE ACCESSORY (K842021)Electronics Research & Production1984-07-20
ELECTRODE, SURFACE EEG ELECTRODE (K842271)Durden Enterprises, Inc.1984-07-20
CALCIUM ASSAY KIT (K842509)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
CREATINE KINASE ASSAY KIT NAC (K842508)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
NEW JERSEY FEMORAL RESURFACING COMPONENT (K842233)Endomedics, Inc.1984-07-20
ASTRON 77 INJECTION DENTURE RESIN (K833270)Astron Dental Corp.1984-07-19
EEG ELECTRODE PAD (K841877)Neurologics, Inc.1984-07-19
SEGURA BASKET (K841942)Van-Tec, Inc.1984-07-19
PROXIMA 1 PH MONITOR (K841384)American Endoscopy, Inc.1984-07-19
ULTRA SHIELD BRIEFS (K841953)Ipco Corp.1984-07-19
GLUCOSE-TRINDER-ADDAY KIT (K842506)Diagnostic Chemicals, Ltd. (Usa)1984-07-19
MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII (K841708)Meloy Laboratories, Inc.1984-07-19
BOVINE THROMBIN, HUMAN THROMBIN (K841956)Haemachem, Inc.1984-07-19
CORPAK FOLEY CATH TRAY W/16FR. TEFLON (K841819)Corpak Co.1984-07-19
DANAM ELEC. SA-1000 (K840649)Danam Electronics1984-07-19
OLYMPUS KC-10 MOBILE DISINFEC-STAT (K841331)Keymed, Inc.1984-07-19
STERILE, FOLEY CATHETERS W/PTFE COAT (K841678)Abco Dealers, Inc.1984-07-19
HEART - AID ALS, 95 (K841556)Cardiac Resucitator Corp.1984-07-19
BOVINE FACTOR XA-HUMAN FACTOR XA (K841957)Haemachem, Inc.1984-07-19
CODE 17-ENDOSCOPE DEODORANT (K840208)Knox Laboratories1984-07-19
ULTRASOUND TRANSMISSION GEL (K842153)Wpc Brands, Inc.1984-07-18
ELEVATOR (K841356)Treace Medical, Inc.1984-07-18
TYCOS SELF-CHECK/DIGITAL FEVER THERMO (K842132)Sybron Corp.1984-07-18
ELEC. DIGITAL THERMOMETER MT-20 & 30 (K842199)Sharp Electronics Corp.1984-07-18
WATER FLOATION BED 800/TC/H (K840881)Western Medical, Ltd.1984-07-18
IVAC 3080 ENTERAL FEEDING PUMP (K842027)Y1984-07-18
SIGNAL ELECTRONIC CLINICAL THERMOMETER (K842317)Yukosha Co., Inc.1984-07-18
TERUMO DIGITAL CLINICAL THERMOMETER (K841740)Terumo Medical Corp.1984-07-18
URIC ACID ASSAY KIT (K842246)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
ALKALINE PHOSPHATASE ASSAY KIT (K842243)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
STEAM STERILIZER (K831356)Ars Enterprises, Inc.1984-07-18
IMPEDANCE/PURE TONE AUDIOMETER MA620 (K841568)Maico Hearing Instruments, Inc.1984-07-18
GLOTTAL FREQUENCY ANALYSER (K841832)Teltec Electronic Equipment AB1984-07-18
ASPARTATE AMINOTRANSFERASE ASSAY KIT (K842245)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
FENESTRA HOOK (K841359)Treace Medical, Inc.1984-07-18
UREA ASSAY KIT (K842242)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
RHINO-LARYNX STROBOSCOPE TYPE 4914 (K842090)Bruel & Kjaer Industri A/S1984-07-18
A.S.A.P. (K841318)Trimedyne, Inc.1984-07-18
ABBOTT LIFECARE 1050 CONTROLLER (K842080)Abbott Laboratories1984-07-18
LACTATE DENYDRO GENASE ASSAY KIT (K842244)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
HOME CARE WATER FLOTATION BED HC4/TC/H (K840882)Western Medical, Ltd.1984-07-18
OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ (K841322)Airmed Corp.1984-07-18
BRONCHOSCOPE SUCTION UNIT (K841399)Keymed, Inc.1984-07-18
ALANINE AMINOTRANSFERASE ASSAY KIT (K842241)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
EMG MODEL 133 (K842354)Calnor of EL Paseo, Inc.1984-07-17
SPOT-FILM DEVICE 8835 (K842184)General Electric Co.1984-07-17
UNIVERSAL EXAMINATION TABLE (K842108)Engineering Dynamics Corp.1984-07-17
GSR, 126, EEG 130-TEMP. 132, EMG 133 (K841895)Calnor of EL Paseo, Inc.1984-07-17
ORTHO BRAND HOME PREGNANCY TEST (K842265)Advanced Care Products1984-07-17
MODEL 811 VERI/TENS & PO (K840098)Verite1984-07-17
VH820 HUMIDIFIER (K842340)Bear Medical Systems, Inc.1984-07-17
BONE DENSITOMETER (K841463)Norland Corp.1984-07-17
CONFORMA (K841559)Beiersdorf, Inc.1984-07-17
HESUNG DISPOSABLE SYRINGE (K841566)Amkor Trading Co.1984-07-17
TEMPERATURE 132 (K842353)Calnor of EL Paseo, Inc.1984-07-17
HESUNG'S HYPERDERMIC NEEDLES (K841565)Amkor Trading Co.1984-07-17
HESUNG'S SOLUTION INFUSION SETS (K841563)Amkor Trading Co.1984-07-17
COLON IRRIGATION UNIT (K840613)Colenz Co.1984-07-17
EEG 130 (K842288)Calnor of EL Paseo, Inc.1984-07-17
HIGH FILTRATION ISO-MASK (K831148)Tecnol New Jersey Wound Care, Inc.1984-07-17
LORAD (K842102)Lorad Medical Systems, Inc.1984-07-17
HESUNG SCALP VEIN SET (K841564)Amkor Trading Co.1984-07-17
BRIMFIELD FIBEROPTIC LIGHT SCOURCE (K841731)Brimfield Scientific Instruments1984-07-16
RADCAL MODEL 4046 RADIONUCLIDE CALIBR (K841785)Radcal Corp.1984-07-16
MAXICAMERA 400T W/BODY CONTOUR TOMOGRA (K841996)General Electric Co.1984-07-16
RADCAL MODEL 4051 RADIONUCLIDE CALIBRA (K841786)Radcal Corp.1984-07-16
BANANA CUFF (K841558)Aspen Laboratories, Inc.1984-07-16
RADCAL MODEL 4050 RADIONUCLIDE CALIB (K841787)Radcal Corp.1984-07-16
MINI-DOPPLER ES-100 (K840542)Hayashi Denki Co., Ltd.1984-07-16
SUNMASTER (K842276)Mt. Hood Mfr., Inc.1984-07-16
RELAX STRESS REDUCTION SYS (K841128)Synapse Software Corp.1984-07-16
CITOJECT CARTRIDGE SYRINGE (K842006)Miles Laboratories, Inc.1984-07-16
ADAPTOR HR-3000 REUSE (K841153)Colorado Medical, Inc.1984-07-16
ATAGO URINE SPECIFIC GRAVITY & SERUM (K842168)Kyoto Diagnostics, Inc.1984-07-16
DISPOSABLE PILLOW (K842336)Monterey Mills, Inc.1984-07-13
DISPOSA-SPEC (K840593)Plasti-Products, Inc.1984-07-13
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Track 1984 automatically

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