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

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RecordFirmDate
BIOFILL BIOCELLULOSE DRESSING STERILE (K950621)The Purdue Frederick Co.1995-12-26
EUROTROL GAS - ISE CONTROL (K955340)Direct Solutions1995-12-26
THE REEL THING (MODIFICATION) (K955439)Biomedical Devices, Inc.1995-12-26
ESP CULTURE SYSTEM - MYCO (K953129)Difco Laboratories, Inc.1995-12-26
COMBIDERM ACD (K954918)Convatec, A Bristol-Myers Squibb Co.1995-12-26
MIRACLE EAR AND AUDIOTONE (K954941)Miracle-Ear, Inc.1995-12-22
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI (K955574)Resound Corp.1995-12-22
LUNG DIFFUSION MIXTURE (K954542)Liquid Technology Corp.1995-12-22
SURELOC CIRCUIT CONNECTOR (K954383)Polamedco, Inc.1995-12-22
SOF - ABRASION BUR (K955294)Trebay Medical Corp.1995-12-22
EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY (K955593)Shippert Medical Technologies Corp.1995-12-22
PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES (K954574)Tillotson Healthcare Corp.1995-12-21
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES (K954573)Tillotson Healthcare Corp.1995-12-21
THERMOPLASTIC SHIELD (K954456)Medtec, Inc.1995-12-21
IMMULITE SHBG (MODIFICATION) (K955440)Diagnostic Products Corp.1995-12-21
ROCHE CONTROL SERUM N (K954655)Roche Diagnostic Systems, Inc.1995-12-21
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) (K954600)Staar Surgical Co.1995-12-21
EASY BREATHING NASAL STRIPS (K955233)Corbett Lair, Inc.1995-12-21
ROCHE CONTROL SERUM P (K954656)Roche Diagnostic Systems, Inc.1995-12-21
TARGETT PATCH (K952606)Cutting Edge Technologies, Inc.1995-12-21
DOCUMENT TDM ULTRA UNASSAYED CONTROL (K955155)Casco Standards1995-12-20
PROSYS BEDSIDE DRAINAGE BAG (K953767)Convatec, A Division of E.R. Squibb & Sons1995-12-20
LYFO(TM) DIFFERIENTAL DISK-PYR (K954812)Microbiologics, Inc.1995-12-20
PROTEC X-RAY DETECTABLE GAUZE SPONGE (K955322)Derivados DE Gasa, S.A. DE C.V.1995-12-19
CYBER III OPTION UM, UC312, UC10, UCIC (K955359)Qualitone1995-12-19
MEPORE (6X7) (K954274)Scott Health Care1995-12-19
SERIM PYLORITEK TEST KIT (K953632)Serim Research Corp.1995-12-18
SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) (K952051)Wembley Rubber Products (M) Sdn Bhd1995-12-15
SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES (K952154)Wembley Rubber Products (M) Sdn Bhd1995-12-15
SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES (K951938)Wembley Rubber Products (M) Sdn Bhd1995-12-15
DISPOSABLE POWDER FREE VINYL SYNTHETIC GLOVES (K955091)Safehealth Medical Supply Corp.1995-12-15
HANYANG SUNGLASSES (K955127)Hanyang Industries, Inc.1995-12-14
OLYMPIC SMART SCALE (K954846)Olympic Medical Corp.1995-12-14
OLYMPIC SMART SCALE (K955177)Olympic Medical Corp.1995-12-14
CIBA CORNING ACS ESTRADIOL-6 ASSAY (K954697)Ciba Corning Diagnostics Corp.1995-12-13
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL (K954799)Roche Diagnostic Systems, Inc.1995-12-13
URINARY GEL DRAINAGE SYSTEM (K952780)P.A.M., Inc.1995-12-12
ACETAL DENTAL/PREFORMED CLASP (K954971)B & H Technical Services , Ltd.1995-12-11
MASSAGER THERAPUTIC, ELECTRIC (K954203)Cisco Sales Corp.1995-12-11
SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES (K952155)Wembley Rubber Products (M) Sdn Bhd1995-12-11
ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES (K954533)Eci Medical Technologies, Inc.1995-12-11
NT SERIES DIGITAL IMAGE MANAGER (K955232)Camtronics, Ltd.1995-12-11
HDL PRECIPITATING REAGENT (K954179)Schiapparelli Biosystems, Inc.1995-12-11
HAMEX TWO (K951028)Northern Orthopaedic Products, Inc.1995-12-11
POWDER FREE LATEX EXAMINATION GLOVES (K954365)Perusahaan Getah Asas Sdn. Bhd.1995-12-11
SHANGHAI POSEDON PLASTIC PRODUCTS VINYL EXAM GLOVES (K954381)Shanghai Poseidon Plastic Products Co., Ltd.1995-12-11
ELASTYREN HYPOALLERGENIC SURGICAL GLOVES (K954535)Eci Medical Technologies, Inc.1995-12-11
ACETAL DENTAL/PREFORMED CLASP (K955946)Pressing DI Monticelli Rag. Stefano1995-12-11
LCX CHLAMYDIA TRACHOMATIS ASSAY (K934622)Abbott Laboratories1995-12-08
MUSTANG (K954376)Temco, Inc.1995-12-08
E-Z BREATHERS (K953042)E-Z Kare Good Health Systems, Inc.1995-12-08
OLYMPIC WARM-BASSINET (K954216)Olympic Medical Corp.1995-12-08
SURGIMOTOR (K954470)W.O.M. World of Medicine GmbH1995-12-08
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION (K954579)Telex Communications, Inc.1995-12-08
UTK-DTE AUTILARY SHIELD (K954146)Mallinckrodt Medical1995-12-06
CAP-AID (K954959)Nebl, Inc.1995-12-06
FACEPLATE (HEARING AID KIT) (K954236)Truetone Hearing Systems, Inc.1995-12-06
TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (K954912)Trebay Medical Corp.1995-12-06
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT (K934014)Biotrol, USA, Inc.1995-12-06
KUO & YANG SUNGLASSES (K955290)Kuo & Yang Industrial Co., Ltd.1995-12-06
OSOM HCG COMBO TEST (K955141)Wyntek Diagnostics, Inc.1995-12-06
BELTONE ULTIMA 80 OTOSONIC POWER PAS (K954936)Beltone Electronics Corp.1995-12-06
UROTRACT I (K955019)Dornier Medtech America, Inc.1995-12-06
BIOCIDE CLEANER/DISINFECTANT (K934150)Juan Sierra1995-12-06
ANTHOS 2010 READER (K955077)Anthos Labtec, Inc.1995-12-04
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (K945876)Wells Johnson Co.1995-12-04
TITANIUM BIRD BEAK PLIER (K955242)Sybron Dental Specialties, Inc.1995-12-01
SPLASH & GO II (K955295)Kid'S Wheel-Chairs1995-11-30
CANYONS BI-DIRECTIONAL CHECK VALVE (K954181)Canyon Medical Products1995-11-29
WHEEL LEMASTER (K954370)Heliarc Specialists, Inc.1995-11-29
KELOCOTE (K954413)Allied Biomedical Corp.1995-11-29
COAT-A-COUNT DIRECT ANDROSTENEDIONE (K954755)Diagnostic Products Corp.1995-11-29
OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM (K953961)Osteonics Corp.1995-11-29
CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (K952184)Carbomedics, Inc.1995-11-29
PROTEAM CUSHION (K953352)Iskra.Med1995-11-29
LIQUICHEK ETHANOL/AMMONIA CONTROL (K955024)Bio-Rad1995-11-28
ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (K952470)R-Group Intl.1995-11-28
EXPANDACELL INJECTO-PAK NASAL PACK (K954845)Shippert Medical Technologies Corp.1995-11-27
CONMED TROGARD ELECTRONIC TROCAR SYSTEM (K954599)Conmedcorp1995-11-27
HUMPHREY FIELD ANALYZER (HFA II) (K954167)Carl Zeiss, Inc.1995-11-24
CHOLESTECH LDX SYSTEM (K954778)Cholestech Corp.1995-11-24
MPH50, MPH65, AND MPH80 (K954666)GE Medical Systems1995-11-24
WALLACH DIGITAL IMAGING SYSTEM (K950630)Wallach Surgical Devices, Inc.1995-11-22
DURASIL (K952612)The S. F. Group, Inc.1995-11-22
BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (K952719)Biocircuits Corp.1995-11-22
PARALLEL (K954007)Johnson & Johnson Consumer Products, Inc.1995-11-22
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) (K953470)Mediquip, Inc.1995-11-21
GENESIS (K953345)Tecan U.S., Inc.1995-11-21
ABG POINT LOK NEEDLE PROTECTION DEVICE (K954015)Devon Industries, Inc.1995-11-20
GIBSON ID A.E. TEST (K953247)Gibson Laboratories, Inc.1995-11-20
OPUS TDM CONTROLS (K954291)Behring Diagnostics, Inc.1995-11-20
MRC-5 CELL CULTURE VIAL (K952727)Viratest Intl., Inc.1995-11-20
CLEAN ROOM WHEELCHAIR (K954328)Forth Research, Inc.1995-11-17
FIELD TREND (K954037)Synemed, Inc.1995-11-17
KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT (K953980)Kreuzer Corp.1995-11-16
MID-STREAM COLLECTION SET-STERILE (K953929)Trinity Laboratories, Inc.1995-11-16
SIME SURGICAL POWDERFREE (K954025)Sime Health, Ltd.1995-11-15
LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION) (K954880)Siam Sempermed Corp., Ltd.1995-11-15
NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (K942855)Evergrade Healthcare Products Sdn Bhd1995-11-15
SIME POWDERFREE PLUS (K954051)Sime Health, Ltd.1995-11-15
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