Atlas FDA

1984

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

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RecordFirmDate
SLO-FLO 40AL ADJUST-FLOW REGULATOR (K834061)S.L.O. Health Products, Inc.1984-01-10
BDH UNIPOLAR FEMORAL COMPONENT A2 (K833403)Carbomedics, Inc.1984-01-10
AMBULATORY MONITORING DEVICE (K833162)Oxford Medilog, Inc.1984-01-10
STERILE OIL AND GUIDEWIRE (K833671)CooperVision, Inc.1984-01-10
HEPARIN COATED BALLOON THERMODILU (K834036)Nova Medical Specialties1984-01-10
BONE PLUGGING TOOL (K834229)Standard Surgical1984-01-10
WELLCOGEN H. INFLUENZAL ZL21 (K833077)Wellcome Diagnostics1984-01-10
COAXIAL VOL. VENTILATOR CIRCUIT (K833459)Airco/Ohio Medical Products1984-01-10
MULTI-LUMEN INTRAVENOUS INFUSION CATH (K833825)Medical Parameters, Inc.1984-01-10
APO A-I RIA KIT-HUMAN PLASMA APOLIP- (K840105)Iso-Tex Diagnostics1984-01-10
COULTER COUNTER MODEL S-PLUS V (K833600)Coulter Electronics, Inc.1984-01-10
DENTAL RUBBERDAM (K833610)Center For Marketing Services1984-01-10
INVASIVE MONITORING KITS (K832907)American Pharmaseal Div. Ahsc1984-01-10
KINETIX MOUTHPIECE (K833420)Kinetix1984-01-10
ATAC 3000 (K832115)Turpen Laboratory Systems, Inc.1984-01-10
DIGITAL RADIOGRAPHY SYS-DPS7100 (K834287)Adac Laboratories1984-01-10
RECON-2 FLOW CONTROLLER (K834260)Precision Metering, Inc.1984-01-10
STERILIZATION OF GORE-TEX SOFT TISSU (K833764)W. L. Gore & Associates, Inc.1984-01-10
WELLCOGEN N. MENINGITIDIS A,C,Y W135 (K833063)Wellcome Diagnostics1984-01-10
DIATEK 600 THERMOMETER SYSTEM (K833568)Diatek, Inc.1984-01-10
SENTINEL SYSTEMS (K833395)Quantitative Medicine, Inc.1984-01-10
LP200 & HP800 SERIES VASCULAR PROSTH (K833716)Intervascular, Inc.1984-01-10
NYLON COMPRESSION STUMP SHEATH (K834143)Ipos Luneburg1984-01-09
PREGNASTICK URINE HCG KIT (K833504)Monoclonal Antibodies, Inc.1984-01-09
MEDICALEX (K831728)Medicalex1984-01-09
MARZ-175 ARTERIAL BLOOD GAS SYRINGE (K833923)Chesebrough-Pond'S U.S.A. Co.1984-01-09
IRRIGATION ASPIRATION KIT (K833405)American Medical Optics1984-01-06
GORE-TEX SURGICAL MEMBRANE (K831516)W. L. Gore & Associates, Inc.1984-01-06
MACHEMER/TANO ROTATING (K833820)Optical Micro Systems, Inc.1984-01-04
RIACOAT T-4 (K833745)Immuno Assay Corp.1984-01-04
DOT VISUAL ACVITY TEST 2000 (K833956)Good-Lite Co.1984-01-04
ASPIRATING HANDLE W/BACKFLUSHING CAPAB (K832560)Precision Medical Instruments, Inc.1984-01-04
TITANGEL HIGH RESOLUTION CONTROL (K833639)Helena Laboratories1984-01-04
MAST TOTAL IGE (K833969)Mast Immunosystems1984-01-04
TESTING VISUAL ACUITY (K833778)Technical Enginuities Co.1984-01-04
OSCAR COLOUR VISION TESTER (K832843)Keeler Instruments, Inc.1984-01-04
TINSDALE ENRICHMENT (K834066)Remel Co.1984-01-04
M.S.D. ASPIRATOR (K832529)Medical Surgical Designs1984-01-04
BI-PLANE DIGITAL FLUOROGRAPHY DFX7000 (K834286)Adac Laboratories1984-01-04
STORZ EXTRA (K833064)Storz Instrument Co.1984-01-04
IL TEST IGG IGA & IGM KITS (K833841)Instrumentation Laboratory CO1984-01-04
BEECHER 20 GA. PROBE (K833800)Beecher Medical Diagnostic Instrumentation1984-01-04
MAST INHALANT PROFILE (K833885)Mast Immunosystems1984-01-04
CLERZ LUBRICATING/REWETTING SOLUTION (K833494)CooperVision, Inc.1984-01-04
TRACH MATE (K834265)Tempe Biomedical, Inc.1984-01-04
COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (K833708)Worthington Diagnostic Systems1984-01-04
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL (K833984)Intl. Diagnostic Technology1984-01-04
ACA THYROXINE UPTAKE CALIBRATOR (K833702)E.I. Dupont DE Nemours & Co., Inc.1984-01-04
DISPOSABLE OCUTOME PROBE (K833371)CooperVision, Inc.1984-01-04
MCGEE FORCEPS (K833607)Microtek Medical, Inc.1984-01-03
MIDDLEBROOK & COHN 7H10 AGAR BASE (K834205)Acumedia Manufacturers, Inc.1984-01-03
IMPLANT MEASURING GAUGE (K833606)Microtek Medical, Inc.1984-01-03
O.B. TAMPONS (K833179)Personal Products Co.1984-01-03
THERAPEUTIC EXCHANGE SYSTEM (K831423)Extracorporeal Medical Specialities, Inc.1984-01-03
INFANT VENT CATHETER 12001 W/SIDE VENT (K834039)Dlp, Inc.1984-01-03
UMI PERCUTANEOUS TRANSHEPATIC CHOLAN (K833937)Universal Medical Instrument Corp.1984-01-03
CUPPED FORCEPS (K833605)Microtek Medical, Inc.1984-01-03
HC PLUS (K833563)Coulter Electronics, Inc.1984-01-03
PENASE (K833888)Oxoid U.S.A., Inc.1984-01-03
GLYCOGLOBIN KIT (K833805)Endocrine Sciences Products1984-01-03
BARD ABSORPTION DRESSING (K831710)C.R. Bard, Inc.1984-01-03
NEGATIVE PRESSURE VENOUS BLOOD LINE (K833906)Erika, Inc.1984-01-03
RAAF CATHETER REPAIR KIT (K832580)Quinton, Inc.1984-01-03
BRUCELLA MEDIA (K834006)Micro Media Laboratories1984-01-03
ROLLER KNIFE-TRANSVERSE -SAGITTAL (K833602)Microtek Medical, Inc.1984-01-03
MSI-HC HEMATOLOGY CONTROL (K834043)Medical Specialties, Inc.1984-01-03
ELECTROCARDIOGRAPH MACHINES, W/ANALYZ (K832092)Fukuda Denshi USA, Inc.1984-01-03
BICARBOLYTE HEMO-DIAL (K833896)Edlaw Pharmaceuticals, Inc.1984-01-03
INTERIM TEMP. CROWN & BRIDGE RESIN (K833261)Coe Laboratories, Inc.1984-01-03
PLASTIC LEG BAG (K831530)Forever-Dry, Inc.1984-01-03
SATIN CAST ECONOCAST (K833287)Genesis Industries, Inc.1984-01-03
COVERUPS (K831703)The Urology Group1984-01-03
ARMBOARD (K833559)Mtd, Inc.1984-01-03
ULTRAFILTRATION CONTROLLER (K832547)Extracorporeal Medical Specialities, Inc.1984-01-03
ANTRUM & ATTIC MIRROR (K833601)Microtek Medical, Inc.1984-01-03
ADJUSTABLE FORK RETRACTOR (K833604)Microtek Medical, Inc.1984-01-03
EUGONIC AGAR (K834206)Acumedia Manufacturers, Inc.1984-01-03
DRUMTO STAPES PROSTHESIS (K832540)Humboldt Products1984-01-03
SHUFFIELD TECH ENEMA TIP (K832960)Shuffield Tech Co.1984-01-03
REPAIR KITS FOR RIGHT ATRIAL CATH (K832774)Quinton, Inc.1984-01-03
NOVEL DISPENSER/PACKAGE (K833955)Dentsply Intl.1984-01-03
NON-INVASIVE CLINICAL VASCULAR LAB (K832679)Life Sciences Manufacturing, Inc.1984-01-03
DERMATOPHYTE TEST MEDIUM (K834010)Micro Media Laboratories1984-01-03
SELECTIVE STREPTOCOCCUS AGAR (K834005)Micro Media Laboratories1984-01-03
C & B 40 PENTRO C & B40 (K833290)Genesis Industries, Inc.1984-01-03
SARNS CARDIOPLEGIA CANNULA Y (K834025)3M Health Care, Sarns1984-01-03
CEPHALOMETER & FIXATOR (K833006)Modern Systems, Inc.1984-01-03
MIDDLEBROOK & COHN 7H11 AGAR BASE (K834204)Acumedia Manufacturers, Inc.1984-01-03
BOS-CM40,50 HOLDER & RESERVOIR BAG (K833670)American Bentley1984-01-03
LEGIONELLA DIFFERENTIATION DISK (K834067)Remel Co.1984-01-03
CEB (K834068)Remel Co.1984-01-03
TAMPONADE BALLOON CUFF (K833859)American Endoscopy, Inc.1984-01-03
NEGATIVE PRESSURE ARTERIAL BLOOD (K833905)Erika, Inc.1984-01-03
SCISSORS SHEA BELLUCC (K833603)Microtek Medical, Inc.1984-01-03
NORMAL GOAT SERUM (K833318)Biosan Laboratories, Inc.1984-01-03
MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM (K834215)Th Charters, Inc.1984-01-03
DRUG STANDARDS (K833276)Supelco, Inc.1984-01-01
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Every clearance here is in the API, with alerts when new ones post.