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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
ELECTONE BTE MODEL AM 130 D (K910100)Electone, Inc.1991-01-29
ELECTONE BTE MODEL AM 240 PPL (K910102)Electone, Inc.1991-01-29
ELECTONE BTE MODEL AM900 PP (K910096)Electone, Inc.1991-01-29
ELECTONE BTE MODEL AM 130 HF (K910103)Electone, Inc.1991-01-29
FULL VIEW OMEGA TABLE (K905827)Med-Tron Products, Inc.1991-01-28
DYNATECH MR4000 MICROPLATE READER (K904567)Dynatech Corp.1991-01-28
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS (K901853)Johnson & Johnson Medical, Inc.1991-01-28
RAPITEX(R) ASL NEW (K903854)Behring Diagnostics, Inc.1991-01-28
143 SERIES BTE (K905692)Gn Danavox, Inc.1991-01-28
SEROMA-CATH CLOSE DRAINAGE SYSTEM (K905733)Dawn Medical1991-01-28
SENSITOUCH (K904769)Ansell Intl.1991-01-28
TRU-TOUCH POWDER FREE (K905503)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-01-28
133 SERIES BTE (K905679)Gn Danavox, Inc.1991-01-28
PATIENT EXAMINATION GLOVES (K905172)Tessile, Inc.1991-01-28
ELECTONE BTE MODEL AM 240 PPI (K910098)Electone, Inc.1991-01-28
SLIDEX STREPTO-KIT (K905020)Vitek Systems, Inc.1991-01-28
FUNKY SUNGLASS (K904981)Monogram International,Inc.1991-01-28
RHEUMAGEN ASO T-CONTROL (K904311)Biokit USA, Inc.1991-01-25
COULTER DART ALT (GPT) REAGENT (K905767)Coulter Electronics, Inc.1991-01-25
FEEL FRESH TOOTHBRUSH KIT (K905090)Fresh Appeal , Ltd.1991-01-25
AIA-PACK HGH (K905757)Tosoh Medics, Inc.1991-01-25
DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 (K904850)Micro Motors, Inc.1991-01-25
COLUMNS LIQUID CHROMATOGRAPHY DPM (K905538)Millpore Corp.1991-01-25
VANCOMYCIN DISK-5 MCG (K905151)Remel Co.1991-01-25
LUPUS(LE)-LATEX TEST (K905531)Immco Diagnostics, Inc.1991-01-25
PARK CITY SHOULDER POSITIONER (K910031)Orthopedic Systems, Inc.1991-01-24
E. COLI 0157 LATEX TEST (K903714)Pro-Lab, Inc.1991-01-24
HYPOALLERGENIC LATEX EXAMINATION GLOVES (K910009)Straitscom1991-01-24
GEN-PROBE LUMINOMETER-LEADER 450 (K905762)Gen-Probe, Inc.1991-01-23
CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II (K904989)Creative Laboratory Products, Inc.1991-01-23
JMB TRADING COMPANY SUNGLASSES (K904161)Jmb Trading Co.1991-01-23
CONDOM SEAL (K903715)Mark Sullivan, M.D., P.C.1991-01-23
ROMFLEX REHAB EQUIP EXTREMITIES UNIT (K910150)Dyna Flex, Intl.1991-01-23
STORZ DRAEGER ROTOR KERATOME (K904845)Storz Instrument Co.1991-01-22
VIDEO OTOSCOPE (K904802)Jedmed Instrument Co.1991-01-22
MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (K905207)Micro Surgical Instruments Corp.1991-01-22
ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT (K910151)Dyna Flex, Intl.1991-01-18
GENNY DENNY IV SHIELD (K905735)Tadco, Inc.1991-01-18
ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT (K910149)Dyna Flex, Intl.1991-01-18
ATI MEDICAL COMFORT PLUS CPM PAD (K910026)Ati Medical, Inc.1991-01-18
PM GLOVE (K905055)Pm Gloves, Inc.1991-01-18
OPTEC 2300 AFVT, ARMED FORCES VISION TESTER (K904828)Stereo Optical Co., Inc.1991-01-18
ZENITH COX FLEXION CHIROPRACTIC TABLE (K905685)Williams Manufacturing Co.1991-01-18
ALADERM (K905678)Aladan Corp.1991-01-18
PATIENT EXAMINATION GLOVES (K905031)Phoenix Medical Technology, Inc.1991-01-18
GASTRO-INTESTINAL ACCU-CULSHURE TM (K903638)Medical Laboratory Automation Systems, Inc.1991-01-18
KODAK SURECELL(TM) STREP A CONTROL FLUID SET (K904589)Eastman Kodak Company1991-01-18
ECLIPSE ICA TRIGLYCERIDES (K905601)Biotope, Inc.1991-01-17
DE-TOX TUBES A AND DE-TOX TUBES B (K904326)Dyna-Tek Industries1991-01-17
SHBG IRMA KIT (K905247)Ventrex Laboratories, Inc.1991-01-17
SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE (K903823)Smith and Nephew Donjoy, Inc.1991-01-16
F.T.I. MEDICAL LIGHT GUIDE (K904378)Fiberoptics Technology, Inc.1991-01-16
HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR (K905393)Frigitronics, Inc.1991-01-16
PATIENT EXAMINATION GLOVES-POWDER FREED (K910045)Pan-Century Rubber Products Sdn. Bhd.1991-01-15
PATIENT EXAMINATION GLOVES-ANATOMICAL GLOVES (K910046)Pan-Century Rubber Products Sdn. Bhd.1991-01-15
PATIENT EXAMINATION GLOVES (K905665)Medical Products Search, Inc.1991-01-15
PATIENT EXAMINATION GLOVES-TEXTURED GLOVES (K910047)Pan-Century Rubber Products Sdn. Bhd.1991-01-15
PATIENT EXAMINATION GLOVES (K905551)Johnson & Johnson Medical, Inc.1991-01-15
ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM (K903733)Institute For Clinical Applications1991-01-15
CHLAMYDIA SYSTEM SOFTWARE (CSS) (K904725)Kallestad Diag, A Div. of Erbamont, Inc.1991-01-14
DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL (K903439)Glovco Malaysia Sdn Bhd1991-01-14
ULTRA WAVE 101 (K905836)Ako USA, Inc.1991-01-14
DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. (K905231)Dale Medical Products, Inc.1991-01-14
ACME MODEL 8500 WHEELCHAIR SCALE (K910055)Acme Medical Scale Co.1991-01-14
PACSNET RESEARCH TOOLKIT (K905199)Siemens Gammasonics, Inc.1991-01-14
PERRY XTENDA CUFF SURGICAL GLOVES (K905537)Smith & Nephew Perry1991-01-11
TRACH COLLAR (K904974)Rotek Corp.1991-01-11
MODEL 556 MONITOR (K905856)Ge Medical Systems Information Technologies1991-01-11
IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER (K905215)Cirrus Diagnostics, Inc.1991-01-11
SRI JOHANI LATEX SURGEONS GLOVES (K904662)Transcorp1991-01-11
ROBERTAZZI NASOPHARYNGEAL AIRWAY (K903618)Eastmed Enterprises, Inc.1991-01-08
PARADERM(TM) SURGEON'S GLOVE ACCESSORY (K904903)Lovell-Schenck, Inc.1991-01-08
MICRO-AIRE 4220-000 OSCILLATING SAW (K905277)Micro Surgical Instruments Corp.1991-01-08
REDI-RELEASE ABSORBENT DRESSING (K904604)Fountain Pharmaceuticals, Inc.1991-01-07
STARCAM 4000 (K904174)General Electric Co.1991-01-04
A2J TELEMETER (K904127)A2j, Inc.1991-01-04
SYSTEMATE GGT (EPOS APPLICATION) #65414 (K905662)Em Diagnostic Systems, Inc.1991-01-04
VARIOUS AFTERLOADING APPLICATORS (K904933)Best Assoc. Corp.1991-01-04
CONTAIN(TM) LASER PLUME FILTER (K902167)Arbor Technologies, Inc.1991-01-04
ANATECH X-RAY GENERATOR (K904114)Continental X-Ray Corp.1991-01-03
RUBEOLA IGM ELISA TEST (K904083)Gull Laboratories, Inc.1991-01-03
DISPOSABLE FACE MASK (K904719)Tri/Bor Medical, Inc.1991-01-02
LANEX EXAM GLOVES (K905667)Mokiem & Julian Industrial Corp.1991-01-02
ORAL-CATH SUCTION CATHETER (K903552)Concord Protex1991-01-02
COOL CAST(R) (K903946)Hawthorne Products, Inc.1990-12-31
BRODA WHEELCHAIR (K905671)Broda Ent., Inc.1990-12-31
ROMFLEX REHABILITATION EQUIPMENT (K905299)Dyna Flex, Intl.1990-12-31
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM (K904795)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-31
BIO-GUARD SHAVE PREP TRAY (K905003)Network Medical Systems, Inc.1990-12-28
MEMORYMATE MODEL 8270 ITE HEARING AID (K905483)3M Company1990-12-28
MEASLES IGG MICROASSAY (K903961)Diamedix Corp.1990-12-28
MAGNESIUM REAGENT (K905544)Amresco, Inc.1990-12-27
NEONATAL VENTILATOR CIRCUIT (K903083)Hudson Respiratory Care, Inc.1990-12-27
AFFINITY FSH TEST SYSTEM (K905592)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-27
CHEM-CHEX LIPID (K905389)Streck Laboratories, Inc.1990-12-26
CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST (K903126)Crystal Diagnostics, Inc.1990-12-26
CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL (K905296)Cholestech Corp.1990-12-26
G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS (K902987)Electromek Diagnostic Systems, Inc.1990-12-26
SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE (K904470)Summit Technology, Inc.1990-12-24
INDX DIP S TICKS (K901597)Intercare Diagnostics, Inc.1990-12-21
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