Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ROS-TR SYSTEM (K884140)Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn1989-03-13
RELLPLATE C KIT, RELLPLATE C BULK PLATES (K884940)American Diagnostic Corp.1989-03-13
HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2 (K890583)Hichem Diagnostics1989-03-13
VIRGO HSV-2 IGG ELISA (K883281)Electro-Nucleonics, Inc.1989-03-10
TRACHEOSTOMY CARE AND CLEANING KITS (K890726)Cypress Medical Products, Ltd.1989-03-10
HI CHEM WASH CONCENTRATE REAGENT #88805 (K890578)Hichem Diagnostics1989-03-10
EXTRA STRENGTH SKIN LESS SKIN CONDOM (K884402)Okamoto USA, Inc.1989-03-10
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE (K890785)Cardiac Pacemakers, Inc.1989-03-10
MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000 (K874232)Health Systems Intl., Inc.1989-03-10
NON-STERILE, BULK GAUZE SPONGES (K890727)Cypress Medical Products, Ltd.1989-03-10
SOKEN PLUS(TM) ELECTRONIC MUSCLE STIMULATOR (K881470)Rehab Medical Specialties, Inc.1989-03-10
CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS (K890504)Gish Biomedical, Inc.1989-03-10
HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT (K890277)Oscor Medical Corp.1989-03-10
VIRGO HSV-1 IGG ELISA (K883282)Electro-Nucleonics, Inc.1989-03-10
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES (K884218)Welch Allyn, Inc.1989-03-10
STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR (K885247)Baxter Healthcare Corp1989-03-10
VIRGO(R) VZV-IGG ELISA (K883427)Electro-Nucleonics, Inc.1989-03-10
DRY TIPS (K890734)Microcopy, Div. Neo-Flo, Inc.1989-03-10
CLINISTAT CHOLESTEROL REAGENT TEST (K884757)Heraeus Kulzer, Inc.1989-03-10
ABUSCREEN FP FOR AMPHETAMINE (K890886)Roche Diagnostic Systems, Inc.1989-03-10
F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM (K884981)S & W Medico Teknik1989-03-10
GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES (K890538)Boston Medical Corp.1989-03-10
VENA CAVA FILTER (K881604)Vena-Tech, Inc.1989-03-10
M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68 (K884982)S & W Medico Teknik1989-03-10
BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 (K885092)Medical Imaging Systems, Inc.1989-03-10
ELECTRODE GEL (K884504)Herbert Stanley Co.1989-03-09
RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM (K884917)Amg Medical Equipments, Inc.1989-03-09
TRIGLYCERIDES - GPO REAGENT (K890337)Alpkem Corp.1989-03-09
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER (K881970)Fisher & Paykel Healthcare, Ltd.1989-03-09
MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150 (K885135)Bennett X-Ray Corp.1989-03-09
TOTAL PROTEIN REAGENT (K890278)Sigma Chemical Co.1989-03-09
ROCKET ENDOCERVICAL BRUSH (K885274)A & A Medical, Inc.1989-03-09
MODEL 702 ECG/RESPIRATION/TEMPERATURE (K884455)Ivy Biomedical Systems, Inc.1989-03-09
BTE HEARING AID OTICON MODEL: E42P (K890704)Oticon Corp.1989-03-09
IMX B2-MICROGLOBULIN (K890421)Abbott Laboratories1989-03-09
OPTIFIELD I AND II AUTOMATED PERIMETERS (K884867)Optimed, Inc.1989-03-09
ALASTIGARD (K890529)Unitek Corp.1989-03-09
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER (K884897)Mennen Medical, Inc.1989-03-09
M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55 (K884983)S & W Medico Teknik1989-03-09
TARGET(TM) QUANTITATIVE HCG (K890131)V-Tech, Inc.1989-03-09
NEYORO 65CF (K890569)Deringer-Ney, Inc.1989-03-09
ARGIS PULMONARY FUNCTION TESTING SYSTEM (K883732)Advanced Signal Processing, Inc.1989-03-09
ABUSCREEN FP FOR BARBITURATES (K890884)Roche Diagnostic Systems, Inc.1989-03-09
KENLOR LIQUID URINE CONTROL (K890577)Kenlor Industries, Inc.1989-03-09
CALIUS-ISABEL CANOVAS SUNGLASSES (K890081)Roseburg SA1989-03-09
M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 (K884984)S & W Medico Teknik1989-03-09
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL: (K890957)Hycor Biomedical, Inc.1989-03-09
NR2000 CARDIAC MONITOR (K883903)Nirad , Ltd.1989-03-09
ULTIMA LITE (K890568)Deringer-Ney, Inc.1989-03-09
ENDOSCOPIC LIGHT SOURCE (K885183)Technology For Imaging, Inc.1989-03-09
WELLSHIRE BASELINK (K890558)American Executive Technology1989-03-09
MEDIMOD(TM), MODEL 8900 (K890705)Medical Devices, Inc.1989-03-09
KENLOR HUMAN SPINAL FLUID CONTROL LIQUID (K890576)Kenlor Industries, Inc.1989-03-09
DELFIA HLH SPEC KIT (K883814)Pharmacia, Inc.1989-03-08
BIOTROL IRON REAGENT (K890395)Biotrol, USA, Inc.1989-03-08
ALKALINE PHOSPHATASE ISOENZYME REAGENTS (K890269)Beckman Instruments, Inc.1989-03-08
MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP (K890457)Medtronic Minimed1989-03-08
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT (K890645)Serono-Baker Diagnostics, Inc.1989-03-08
ADMS BIOPSY NEEDLE (K890203)Advanced Diagnostic Medical Systems, Inc.1989-03-08
MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 (K890534)Fisher Scientific Co., LLC1989-03-08
FLIPSCREEN (TM) TOTAL E IMMUNOASSAY (K885307)Alerchek, Inc.1989-03-08
PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP (K884133)Preemicare Corp.1989-03-08
ALLEVYN TRACHEOSTOMY DRESSING (K890748)Smith & Nephew United, Inc.1989-03-08
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES (K884528)Heraeus Kulzer, Inc.1989-03-08
SHAPE-ACTIO URINALYSIS CONTROLS (K890442)Actio, Inc.1989-03-08
ASPARTATE AMINOTRANSFERASE (AST) (K884724)Catachem, Inc.1989-03-08
MODEL 1000 ELECTRONIC CLINICAL THERMOMETER (K885187)Mon-A-Therm, Inc.1989-03-08
C&T PREGNANCY TEST KIT (K884489)Healthcheck Corp.1989-03-08
TOTAL PROTEIN REAGENT (K890317)Medical Analysis Systems, Inc.1989-03-08
DELFIA SHBG KIT (K884809)Pharmacia, Inc.1989-03-08
VAC-RITE (K885334)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-03-08
BIOPSY NEEDLE GUIDE ATTACHMENT (K890327)Elscint, Inc.1989-03-08
STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE (K890669)Norfolk Scientific, Inc.1989-03-08
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4 (K890675)Unipath , Ltd.1989-03-06
RESPIRATORY AIRWAY TUBE MONITOR (RATM) (K883158)Vascucare, Inc.1989-03-06
EURO-MED LIGHT TOUCH BIOPSY PUNCH (K884740)Buckman Co., Inc.1989-03-06
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL (K884106)Siemens Medical Solutions USA, Inc.1989-03-06
TOTAL BILIRUBIN REAGENT, CONCENTRATED (K890070)Trace Scientific , Ltd.1989-03-06
SPINAL ANESTHESIA TRAY (K885277)Preferred Medical Products1989-03-06
STONY BROOK MODEL EECP-MC1 (K882401)Stony Brook Trading and Development Corp.1989-03-03
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION (K885281)Baxter Healthcare Corp1989-03-03
AM TM SYRGICAL DRAPES (K882643)Henley Intl.1989-03-03
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH (K885045)Baxter Healthcare Corp1989-03-03
AGEN DIMERTEST EIA (K890189)Agen Biomedical , Ltd.1989-03-03
SPQ(TM) ANTIBODY REAGENT SET II FOR TRF (K890563)Atlantic Antibodies1989-03-03
REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES (K884103)Boehringer Laboratories1989-03-03
KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE) (K890311)Kosan Far East Ent. , Ltd.1989-03-03
MALIS BIPOLAR CORD/IRRIGATION TUBING SET (K890648)Valley Forge Scientific Corp.1989-03-03
CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200 (K884025)Circon Acmi1989-03-03
CAVROLAB (K882585)Life-Tech Intl., Inc.1989-03-02
MODEL OX-1 OXYGEN SATURATION MODULE (K884822)Colin Medical Instruments Corp.1989-03-02
ASTRO TRACE (MODEL AT-01) (K884592)The LE Blanc Corp.1989-03-02
KMI OXY-BAN (K883848)Knight Medical, Inc.1989-03-02
WELLSHIRE EMLINK MODEL 1000 (K890508)American Executive Technology1989-03-02
DENTOCULT SM-STRIP MUTANS (K890199)Orion Corp.1989-03-02
LYME ELISA TEST SYSTEM (K885317)Zeus Scientific, Inc.1989-03-02
LANCER - MODULAR POWER BASE (K890723)Everest & Jennings, Inc.1989-03-02
KONTRON PULSE OXIMETER 7840 (K890299)Kontron Instruments, Inc.1989-03-02
SARNS VENT CATHETER (K890024)3M Company1989-03-02
PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH. (K890492)Endosonics Corp.1989-03-02
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