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

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RecordFirmDate
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III (K911168)Analytical Control Systems, Inc.1991-05-01
SUNGLASSES (K910415)K.M Optical Co.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III (K911178)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I (K911169)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II (K911167)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III (K911171)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II (K911177)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I (K911176)Analytical Control Systems, Inc.1991-05-01
THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II (K911170)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1 (K910930)Analytical Control Systems, Inc.1991-05-01
DR. DEDO'S FAMILY EAR EXAMINATION KIT (K904659)Panex Corp.1991-04-30
ARTHROBOT(TM) WRIST HOLDER ACCESSORY (K911522)Andronic Devices, Ltd.1991-04-29
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST (K905787)Vitek Systems, Inc.1991-04-29
J&S PEDIATRIC IRON SATURATING REAGENT (K910672)J.S. Medical Assoc.1991-04-29
ELECTROSONOGRAM ESG-1 (K905449)Myo-Tronics, Inc.1991-04-26
SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2 (K910597)Radix Group Intl.1991-04-26
SPLASH GUARD (K905173)E.M. Adams1991-04-25
EUDERMIC SURGICAL GLOVES (K911245)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-04-25
PATIENT EXAMINATION LATEX GLOVES (NON-STERILE) (K911694)Guthrie Medicare Products (Melaka) Sdn Bhd1991-04-25
PLASTIC (VINYL) EXAMINATION GLOVES (K910879)Siamount Plastic Corporation , Ltd.1991-04-25
STANDARD RUBBER DAM WITH OR WITHOUT FRAMES (K905470)Elastomade Accessories Sdn Bhd1991-04-25
MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT (K904538)Mauna Loa Medical, Inc.1991-04-24
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T (K911405)Eastman Kodak Company1991-04-23
CCI CORNEAL SCARIFIER (K904505)Buckman Co., Inc.1991-04-23
STYLET TRACHAEL TUBE (K905133)Medical Devices, Inc.1991-04-22
I/A HANDPIECE WITH REPLACEABLE TIPS (K910245)Surgical Technologies, Inc.1991-04-22
CUSTOM PERSONAL EAR - CPE (K911497)Qualitone1991-04-19
ULTRA & ULTRA LITE II, MODIFICATION (K911504)Qualitone1991-04-19
ADJUSTRETTE - DAO, MODIFICATION (K911498)Qualitone1991-04-19
JENSEN III CHIROPRACTIC J-TABLE (K905647)Freedman, Wolk and Co.1991-04-19
ELEGANCE - DEO, MODIFICATION (K911499)Qualitone1991-04-19
VARIOUS TEMPLATE APPLICATORS (K910862)Best Industries1991-04-18
DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER (K904783)Industrial Chemical Measurement1991-04-18
SOPHYCAMERA DSX BODYTRAK (K911346)Sopha Medical Systems, Inc.1991-04-18
TAN CHONG GLOVE, HYPOALLERGENIC (K911146)Boston Medical Corp.1991-04-18
QUIDEL HELICOBACTER PYLORI TEST (K903099)Quidel Corp.1991-04-17
PHONAK 9100 SC-AF ITE HEARING INSTRUMENT (K911211)Phonak, Inc.1991-04-17
IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE (K910816)Insight International, Inc.1991-04-17
CATHETER, NASAL, OXYGEN (K902420)Gainor Medical Europe, Ltd.1991-04-17
OXYFRESH OXYCARE 3000 (K910832)Oxyfresh1991-04-17
MOBILE TREATMENT CART (K910243)Jedmed Instrument Co.1991-04-17
PHONAK 9800 SC-AF ITE HEARING INSTRUMENT (K911210)Phonak, Inc.1991-04-17
TRAY DOUGH (K911225)The Hygenic Corp.1991-04-17
CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL (K905457)Consolidated Technologies, Inc.1991-04-16
REP SPE PLUS (ACID BLUE) SYSTEM (K911468)Helena Laboratories1991-04-16
LATEX EXAMINATION GLOVES (HYPOALLERGENIC) (K911447)Aladan Corp.1991-04-16
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K (K911339)Shimadzu Medical Systems1991-04-16
OPUS FSH (K911409)Pb Diagnostic Systems, Inc.1991-04-16
PHONAK 9300 SC-AF ITE HEARING INSTRUMENT (K911209)Phonak, Inc.1991-04-15
MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM (K910167)Microbio-Medics, Inc.1991-04-15
AHL, ITE MODEL AMERICAN (K910325)Bob Bare Hearing Aid Repair1991-04-15
PERIOGARD(R) PERIOPEN (K901955)Colgate-Palmolive Co.1991-04-15
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS (K904752)Boehringer Mannheim Corp.1991-04-12
LANEX EXAM GLOVES (K910977)Multi M Intl., Inc.1991-04-12
ANTI-FOG DISPOSABLE IV INDUCTION COVER (K910104)Central Plastic, Inc.1991-04-12
OHMEDA - LOW FLOW FLOWMETER (K910316)Ohmeda Medical1991-04-12
VISI-STREP (K910537)Kev Connecticut Diagnostics, Inc.1991-04-12
INCARE PINSITE DRESSING (K905206)Hollister, Inc.1991-04-12
UTAK LABORATORIES TOXICOLOGY CONTROL (K903061)Utak Laboratories, Inc.1991-04-12
ALLDRESS MULTI LAYERED WOUND DRESSING (K910857)Scott Health Care1991-04-12
LH IRMA IMMUNOMAG (K911050)Pantex, Div. Bio-Analysis, Inc.1991-04-12
CHALLENGE (TM) LIQ THERA DRUG CONTROLS (K910333)Medical Analysis Systems, Inc.1991-04-12
EBV IGG ELISA TEST (K910872)Gull Laboratories, Inc.1991-04-12
OPTICAL FRAME (K910179)Australian Optical Co., Inc.1991-04-10
MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER (K900557)Monaghan Medical Corp.1991-04-10
LOW VISION ENHANCEMENT SYSTEM (LVES) (K910124)Triangle Investments1991-04-10
MICROTEST MULTI MICROBE MEDIUM (K910526)Microtest1991-04-09
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES (K905288)Med-Tek Innovations, Inc.1991-04-09
VARIOUS TYPES OF STETHOSCOPES (K905487)Liaoning-Usa Corp.1991-04-09
MODEL FT40 TRANSONIC(TM) HEARING AID (K905516)Sonovation, Inc. Dba Avr Sonovation1991-04-09
CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS (K910020)Capintec Instruments, Inc.1991-04-08
ENZYMUN-TEST PROGESTERONE (K910683)Boehringer Mannheim Corp.1991-04-08
PROBE SURGEON'S GLOVES- STERILE (K905624)Glove India Pvt. , Ltd.1991-04-08
SYNCHRON LACTATE REAGENT (K910534)Beckman Instruments, Inc.1991-04-08
EQUIPMENT/MATERIAL DECONTAMINATING KIT (K911299)Rohm and Haas Co.1991-04-08
SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES (K910036)Surgical Technologies, Inc.1991-04-04
SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER (K910185)Beckman Instruments, Inc.1991-04-03
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION (K910666)Vitek Systems, Inc.1991-04-03
RESORBABLE BONE PLUG (K905740)Zimmer, Inc.1991-04-03
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2 (K910829)Bio-Rad1991-04-03
ELECTONE ITE MODEL PREMIER (K910097)Electone, Inc.1991-04-03
DENTAURUM CERAMIC DEBONDING UNIT (K902018)Dentauraum, Inc.1991-04-03
BIVONA ENDOTRACHEAL TUBE STYLET (K905052)Bivona Medical Technologies1991-04-02
SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (K910783)Smith & Nephew Equipment Group1991-04-02
RSVP RF-2000 (K905586)Tactilitics, Inc.1991-04-01
WEEVAC TC HAND CARRIED RESCUE STRETCHER (K910709)W. Murphy Ent., Inc.1991-04-01
GOOD VIBRATIONS TUBE MASSAGER (K910519)Dual Voltage, Inc.1991-04-01
CUTINOVA HYDRO (K905688)Beiersdorf, Inc.1991-04-01
TEKDYNE MICRO RETRACTOR (K910975)Tekdyne1991-04-01
TEMPERATURE PROBE (K905148)Tec II Medical, Inc.1991-04-01
VISI-STAPH (K905617)Connecticut Diagnostics, Ltd.1991-03-29
AMPRO SURGEON'S GLOVES (K910711)American Pro Latex, Inc.1991-03-29
PALPATION PROBE (K911159)Northgate Technologies, Inc.1991-03-29
MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM (K911158)Northgate Technologies, Inc.1991-03-29
NONSTAINING ALASTIKS (K910288)Unitek Corp.1991-03-29
STEADFAST DENTURE ADHESIVE POWDER (K910216)Stiefel Research Institute, Inc.1991-03-29
CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS (K911180)Northgate Technologies, Inc.1991-03-29
YOURS TRULY ASYMMETRICAL BREAST FORM (K911247)Jobst Institute, Inc.1991-03-29
DU PONT IDENTIFICATION CAMERA (K910354)Dupont Medical Products1991-03-29
STREPTEX ACID EXTRACTION KIT (K910797)Wellcome Diagnostics1991-03-29
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