Atlas FDA

1983

3,564 FDA 510(k) clearances · Clearance year

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RecordFirmDate
NEPHROLYTE (K831502)Flaitron Laboratories, Inc.1983-07-18
HSV IGM TEST (K830865)Gull Laboratories, Inc.1983-07-18
FLUORESCEIN CONJUGATED IMMUNOGLOBIN- (K831902)Dako Corp.1983-07-18
LEAP RHEUMATOID FACTOR TEST KIT (K831941)Cooper Diagnostics, Inc.1983-07-18
CERTAIN HB CO-OXIMETER CONTROL (K832028)Corning Medical & Scientific1983-07-18
ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY (K831826)Damon Corp.1983-07-18
HYPER-HYPOTHERMIA UNIT HYPO 10-200 (K831677)Gambro, Inc.1983-07-18
STAINLESS STEEL GUIDE WIRE (K831839)Quinton, Inc.1983-07-18
DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB (K831957)Kent Laboratories, Inc.1983-07-18
RABBIT ANTISERUM TO HUMAN IGA (K831909)Dako Corp.1983-07-18
VIVONEX TUNGSTEN TIP TUBE-MONOFILA- (K831970)Norwich Eaton Pharmaceuticals, Inc.1983-07-18
FLUORETS STERILE OPHTH. STRIPS (K831621)Smith & Nephew, Inc.1983-07-18
RABBITT ANTISERUM TO HUMAN C3C (K831905)Dako Corp.1983-07-18
WAKO CHOLESTEROL CII (K831687)Wako Chemicals USA, Inc.1983-07-18
OMNIPROBE ELECTRICAL NERVE STIMULATOR (K831147)Omni Intl., Inc.1983-07-18
DIRECT BILIRUBIN REAGENT (K831844)Gilford Diagnostics1983-07-18
DACOMED SNAP-GAUGE (K832121)Dacomed Corp.1983-07-18
INFANT EVALUATION CARRIER (K831731)E.M. Adams1983-07-18
DIFFERENTIA/DIAGNOSTIC OCCLUSA/APPLIANC (K831344)Brimms, Inc.1983-07-18
WAKO R-GTP C-TEST (K831639)Wako Chemicals USA, Inc.1983-07-18
LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- (K831774)Diagnostic Reagent Tech.1983-07-18
MODEL #27224P CONTINUOUS FLOW PUMP (K832009)KARL STORZ Endoscopy-America, Inc.1983-07-18
ARTHROSCOPY INFUSION SYS..VALVE (K831218)Acufex Microsurgical, Inc.1983-07-18
CONTINUOUS FLUSH DEVICE (K831730)American Pharmaseal Div. Ahsc1983-07-18
ANTINUCLEAR ANTIBODY TEST KIT (K831927)Breit Laboratories, Inc.1983-07-18
EXTERNAL INCONTINENCE CATHETER SET-NON (K832108)Plasco, Inc.1983-07-18
RABBIT ANTISERUM TO HUMAN IGG (K831908)Dako Corp.1983-07-18
MSI-NAK-50 TEST KIT (K831300)Medical Specialties, Inc.1983-07-18
CELL-DYN 300 HEMATOLOGY ANALYZER (K832038)Abbott Diagnostics1983-07-18
GENERAL SURGICAL INSTRUMENTS (K831805)Aim Corp.1983-07-14
PERSONAL AMPLIFIER MODULE (K830790)Electone, Inc.1983-07-12
LACIMAL INTUBATION SETS (K831901)Visitec Co.1983-07-12
SCENTED MENSTRUAL PAD (K832215)Personal Products Co.1983-07-12
NURSE CALL BUTTON (K832057)Qa Alert Systems1983-07-12
TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 (K831392)Travenol Laboratories, S.A.1983-07-12
MICROVEL DOUBLE VELOUR SUPPORTED 100 (K822633)Meadox Medicals, Div. Boston Scientific Corp.1983-07-12
LAMOREUX-OSI ELECTROGONIOMETER (K831040)Orthopedic Systems, Inc.1983-07-12
SIALOGRAPHY NEEDLE (K831666)Vertex Medical Corp.1983-07-12
ENDODONTIC BROACH(76EKN) BARBED BROACH (K831749)Union Branch1983-07-12
DROP RATE COUNTER #340 (K831596)Imed Corp.1983-07-12
DISPOSABLE CYSTOTOME (K831916)CooperVision, Inc.1983-07-12
OCULAR IRRIGATING CANNULA (K831532)Dey Laboratories, Inc.1983-07-12
COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG (K831888)Portable Travtion Device Co.1983-07-12
ORTHOPEDIC SURGICAL GLOVE (K831564)Ansell, Inc.1983-07-12
STRESS MACHINE (K831699)Dr. William F. Curran1983-07-12
HERAPIN LOCK FLUSH SOLUTION USE KIT (K831765)Smith & Nephew, Mpl Division1983-07-12
SONIC MIST ULTRASONIC HUMIDIFIER (K831646)Douglas Products1983-07-12
INTERFERENCE MEDULLARY FIT -IMF-HIP (K831314)Depuy, Inc.1983-07-12
ENDODONTIC ROOT CANAL PLUGGER FINGER- (K831748)Union Branch1983-07-12
WEBER/STIIHMER FEMORAL HEAD PROSTHESIS (K830948)Allo Pro Corp.1983-07-12
UNIVERSAL PACK (K831701)Atlantic Optical Systems, Inc.1983-07-12
NICOLET EMG SATELLITE (K830702)Nicolet Biomedical Instruments1983-07-12
COMMAND ULTRA II (K831216)Cardiac Pacemakers, Inc.1983-07-12
HEAD-IMMOBILIZER (K832001)Int'L Safety Corp.1983-07-12
BARD INTRAMEDULLARY PLUG (K831128)C.R. Bard, Inc.1983-07-12
ELECTRONIC CLINICAL THERMOMETER (K831718)Mitteloy1983-07-12
STRYKER LEG EXERCISER (K831910)Stryker Corp.1983-07-12
MICRO SURGICAL HANDLE (K831996)Visitec Co.1983-07-12
DOBBHOFF FEEDING TUBE W/HYDROMER LUB (K831868)Biosearch Medical Products, Inc.1983-07-12
THORACIC GAUGE #TG-60 -VACUUM REGULATOR (K831505)Sorensen Research1983-07-12
SURGICAL APPAREL SHOE COVERS (K831952)Sudreca Surgical Dressings, Inc.1983-07-12
BROOKS SCLEROTHERAPY CUFF (K823475)Inmed Corp.1983-07-12
PORTABLE MONITORING & SCREENING SPIROM. (K822689)Boehringer Laboratories1983-07-12
DAP II BIOPSY GUIDE (K830999)Rapid Machine & Tool Corp.1983-07-12
AS 30/TCP MODULE (K831460)Narco Scientific1983-07-12
AXCAN SPERM CUP (K831669)Axcan Scientific Corp.1983-07-12
THIGH HOLDER (K832000)Richards Manufacturer Co.1983-07-12
SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 (K822411)Western Advanced Technology, Inc.1983-07-12
INTRADISCAL THERAPY NEEDLE (K831610)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-07-12
LEATHER VALVE CUTTER (K831455)American V. Mueller1983-07-07
OMAR (K830915)Oxford Medilog, Inc.1983-07-07
RIONET HEARING AID -AND/OR RION (K831721)Rion Acoustic Instruments, Inc.1983-07-07
INDIRECT FLUORO-KIT HSV (K830623)Clinical Sciences, Inc.1983-07-07
MICRO-AIRE REPLACEMENT SURG. SAW BLADE (K831714)Micro-Aire Surgical Instruments, Inc.1983-07-07
SURGEON'S CHOICE CRUTCH HANDLE (K831889)W.K. Wheeler, Inc.1983-07-07
ELECTROPHORESIS CONTROLS-3 IN 1 (K831263)Corning Medical & Scientific1983-07-07
SURGICAL DRILL BITS (K831712)Medical Specialists IN Packaging1983-07-07
UREA NITROGEN-BUN-REAGENTS B6360-12 (K831625)American Scientific Products1983-07-07
MA 610-IMPEDANCE AUDIOMETER (K831754)Maico Hearing Instruments, Inc.1983-07-07
UREA NITROGEN-BUN-REAGENTS B6370-11A (K831626)American Scientific Products1983-07-07
NON CONDUCTIVE ANESTHESIA FACEMASK (K831713)Vital Signs, Inc.1983-07-07
HEMOCLAV VENOUS CATHETER (K831801)Exo, Inc.1983-07-07
ALPHA-STIM 350 (K831145)Electromedical Products, Inc.1983-07-07
ARTIFICIAL KIDNEY BLOOD CIRCUIT (K831770)Eiken Kizai Co., Ltd.1983-07-07
NEUROTRAC (K831715)Hdc Corp.1983-07-07
RESTROSPECTIVE ECG MEMORY MODULE (K831406)Cardiac Evaluation Center, Inc.1983-07-07
SALICYLATE ASSAY KIT (K831336)Quantimetrix Corp.1983-07-07
CYPRANE TEC 4 CONTINUOUS FLOW VAPOR. (K831427)Fraser Harlake, Inc.1983-07-07
CHLAMYDIA OVERBY MEDIA (K831686)Viromed Laboratories, Inc.1983-07-07
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW (K831720)Sherwood Medical Co.1983-07-07
AMYLAST-D TEST (K831561)Sclavo, Inc.1983-07-07
ACU-PUNCH (K831635)Acuderm, Inc.1983-07-07
SUPPORT PRODUCTS EXAMPLE PROSET CAST (K830650)Isopedix Corp.1983-07-07
GUILLOTINE BLADE (K831772)Ortho Pared Instruments, Inc.1983-07-07
TRACHEA/CUFF INFLATOR W/PRESSURE #583 (K831577)Medical Electronics Corp.1983-07-07
TEFLON FEMORAL CATHETER MWI 100,10 & (K831828)Med-West, Inc.1983-07-07
ENSWELL (K831899)Dr. Micheal A. Sabia1983-07-07
GUM MACHINE (K831321)The Gum Machine Co.1983-07-07
TRACHEOSTOMY TUBE (K831511)Implant Technology, Inc.1983-07-07
VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR (K830916)Bib, Inc.1983-07-07
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