Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
WHEELCHAIR, MECHANICAL (K850064)Comaco, Inc.1985-04-04
CLINICAL ELECTRONIC THERMOMETERS (K850244)Sheridan Catheter Corp.1985-04-04
NORELCO DIGITAL MODEL 970 THERMOMETER (K851075)Philips Park1985-04-04
QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR (K850252)Telectronics, Inc.1985-04-04
KONTRON MINIMON 7134 PATIENT MONITOR (K844215)Kontron Instruments, Inc.1985-04-04
MATRIX 101 NEGATIVE GALVANIC GENERATOR (K844816)Prn Medical1985-04-04
ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. (K844988)Ethox Corp.1985-04-04
TRAVENOL FLO-GARD 500 IV MONITOR (K850710)Travenol Laboratories, S.A.1985-04-04
MODEL 492-01 PACEMAKER LEAD (K813136)Intermedics, Inc.1985-04-03
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- (K850865)Erika, Inc.1985-04-03
URETERAL DILATOR & URETERAL STONE DISLODGER (K850954)American Edwards Laboratories1985-04-03
NYTONE ENURETIC ALARM BEDWETTING DEVICE (K844866)Nytone Medical1985-04-03
ABBOTT TDT EIA (K843908)Abbott Laboratories1985-04-03
INFUSION SLEEVE - OPHTHALMIC (K851009)Medical Instrument Development Laboratories, Inc.1985-04-03
SENTRY SIGNAL ENURESIS ALARM SYSTEM (K844636)Conklin Technology, Inc.1985-04-03
BED SENTRY, MODEL 50U (K850538)Metatech Corp.1985-04-03
PHACOEMULSIFICATION TIP (K850578)Ultramed, Inc.1985-04-03
TBM-REAGENT FOR T,B CELL & MONOCYTES (K843062)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-04-03
INTERMEDICS POLYFLEX PACING LEAD #480-01 (K820267)Intermedics, Inc.1985-04-03
PUL,MONARY ARTERY VENT CATHETER (K845046)Dlp, Inc.1985-04-03
ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR (K850271)Angiomedics, Inc.1985-04-03
DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 (K850580)Elscint, Inc.1985-04-03
PROGRAMMABLE PATIENT SIMULATOR (K844464)Ramford Labs1985-04-03
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER (K851112)The Huxley Instrument Corp.1985-04-03
POLY FLEX IMPLANTABLE PACING LEAD (K802294)Intermedics, Inc.1985-04-03
PARATHYROID HORMONE RADIOIMMUNOASSAY KIT (K850254)Cambridge Medical Technology1985-04-03
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR (K851113)The Huxley Instrument Corp.1985-04-03
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L (K850866)Erika, Inc.1985-04-03
I-L TEST, DIRECT BILIRUBIN SET (K850748)Allied Instrumentation Laboratory1985-04-03
MODEL 486-01 PACEMAKER LEAD (K813135)Intermedics, Inc.1985-04-03
RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV (K851111)The Huxley Instrument Corp.1985-04-03
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C (K851032)Roche Diagnostic Systems, Inc.1985-04-03
VENOUS RETURN CATHETER SS-1 (K845045)Dlp, Inc.1985-04-03
DIMERTEST LATEX (K842277)Mabco, Inc.1985-04-03
LEECO CONCEP-7-BHCG EIA (K850531)Leeco Diagnostics, Inc.1985-04-02
LEECO CONCEP-7-BHCG IRMA (K850530)Leeco Diagnostics, Inc.1985-04-02
OSTEON BONE MINERAL ANALYZER (K843922)Osteon, Inc.1985-04-02
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY (K850570)American Dade1985-04-02
TECA MF-20 MICROVASCULAR DOPPLER (K850071)Teca, Inc.1985-04-02
MODEL SERUM HCG ASSAY (K850730)Monoclonal Antibodies, Inc.1985-04-02
TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR (K850747)Tri-Med, Inc.1985-04-02
DROPSTIRS - PLASTIC DISPOSABLE PIPET (K850800)Berwick Medical Products, Inc.1985-04-02
TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF (K850004)Todd Medical, Inc.1985-04-02
EMIT D.A.U. PROPOXYPHENE ASSAY (K850920)Syva Co.1985-04-02
TRI-MED MODEL 112 MOISTURE TRAP (K850745)Tri-Med, Inc.1985-04-02
TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI (K850746)Tri-Med, Inc.1985-04-02
MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT (K850779)Cooper Lasersonics, Inc.1985-04-02
MUFFLER GAS-AIR VENT UNIT (K832170)Dr. Edward Richards1985-04-02
MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT (K844850)Medicorp, Inc.1985-04-02
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (K850239)Toa Medical Electronics USA, Inc.1985-04-01
FLO-PHORESIS - DESENSITIZER (K844989)Eastco, Inc.1985-04-01
SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE (K844995)Cropper Medical, Inc.1985-04-01
CSR WRAP - CENTRAL SUPPLY ROOM WRAP FOR STERIL- (K844920)Papeteries Depont-Audemer1985-04-01
URI-KIT (K850998)Culture Kits, Inc.1985-04-01
APPLIED GAUZE SPONGE 4X4X8 (K844676)Applied Medical1985-04-01
DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE (K850986)Data Medical Associates, Inc.1985-04-01
SPOTTEST INDIA INK (K851184)Difco Laboratories, Inc.1985-04-01
GAUZE SPONGE 4X4X12 PLY (K844726)Applied Medical1985-04-01
CEFTRIAXONE 30 MCG SENSITIVITY DISCS (K850606)Difco Laboratories, Inc.1985-04-01
PHYSIOLOGICAL MONITOR 2100 (K844353)Datascope Corp.1985-04-01
GAUZE ASORBABLE (K844702)Medicon, Inc.1985-04-01
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR (K850651)Pacesetter Systems1985-04-01
EMIT 700 METHADONE ASSAY (K850953)Syva Co.1985-04-01
CALIBRATOR B 88133 (K850405)Hi Chem, Inc.1985-04-01
APPLIED GAUZE SPONGE 3X3X12 (K844675)Applied Medical1985-04-01
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH (K850250)Technicon Instruments Corp.1985-04-01
BED PRODUCTS (K850470)Abco Dealers, Inc.1985-04-01
APPLIED GAUZE SPONGE 2X2X8 PLY (K844674)Applied Medical1985-04-01
CORRECT FLO INTRAVASCULAR ADMINISTRATION SET (K850506)Biomedical Dynamics, Inc.1985-04-01
DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX (K844839)Critikon Company, LLC1985-04-01
EYEDENTITY EYEWEAR (K851039)Vitech Research C/O Johnsen, Manfredi & Thorpe1985-04-01
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE (K850901)Data Medical Associates, Inc.1985-04-01
DERAPAGE EYEWEAR BY VITALONI (K851062)Vitaloni S.P.A.1985-04-01
CHOCOLATE AGAR W/BACITRACIN, CHOCOLATE W/BACITRACI (K850555)Hardy Media1985-04-01
MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT (K844976)Medi-Man Rehabilitation Products, Inc.1985-04-01
SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - (K844910)Toa Medical Electronics USA, Inc.1985-04-01
APPLIED GAUZE SPONGE 4X4X16 PLY (K844673)Applied Medical1985-04-01
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER (K850659)Syva Co.1985-04-01
APPLIED GAUZE SPONGE 2X2X12 (K844677)Applied Medical1985-04-01
SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS (K850503)Turn Needle Intl., Inc.1985-04-01
PHACO-BAC STOP KIT (K850900)Staar Surgical Co.1985-03-29
I/A BAC STOP KIT (K850899)Staar Surgical Co.1985-03-29
URI-VAL (K843680)Cenogenics Corp.1985-03-29
MIC-CONCEPT INOCULUM SEED TRAY (K851019)Microtech Medical Systems, Inc.1985-03-29
LASER-GLOBIN (K850096)Hematology Marketing Assoc.1985-03-29
BETASONIC III (K850116)Teknar, Inc.1985-03-29
NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER (K850487)Novametrix Medical Systems, Inc.1985-03-29
LANDERS VITRECTOMY LENS RING SYSTEMS (K850991)Ocular Instruments, Inc.1985-03-29
ICS THEOPHYLLINE REAGENTS (K850856)Beckman Instruments, Inc.1985-03-29
NSI LYSING-D REAGENT -4000 ML (K850944)Nobel Scientific Industries, Inc.1985-03-29
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI (K850054)E.I. Dupont DE Nemours & Co., Inc.1985-03-29
LASER-DIL (K850095)Hematology Marketing Assoc.1985-03-29
TRYPSIN-EDTA SOLUTION (K850679)Hazleton Research Products, Inc.1985-03-29
BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA (K850970)Granite Diagnostics, Inc.1985-03-29
LASER-GLOBIN POWDER (K850094)Hematology Marketing Assoc.1985-03-29
INHIBITORY MOLD AGAR PLATE (K850969)Granite Diagnostics, Inc.1985-03-29
CTAPI - NEISSERA SCREEN (K850982)Analytical Products, Inc.1985-03-29
CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASEQ (K850832)Oxoid U.S.A., Inc.1985-03-29
MIC-CONCEPT INOCULATOR (K851020)Microtech Medical Systems, Inc.1985-03-29
ISOENZYME TEST LD-1 (K850210)Sclavo, Inc.1985-03-29
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