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

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RecordFirmDate
ACTIVE IGF-I ELISA (K951752)Diagnostic Systems Laboratories, Inc.1995-05-10
DSL ACTIVE IFGBP-3 ELISA (K951707)Diagnostic Systems Laboratories, Inc.1995-05-10
INTRAORAL VIDEO SCOPE AND WINDOW TUBE (K951019)Cuda Products Co.1995-05-10
FMS ARTHRO-CUTTER (K951701)Future Medical Systems, Inc.1995-05-09
WAHL FRESH FACE (K944909)Wahl Clipper Corp.1995-05-08
AURAFLEX PROGESTERONE 150TEST PACK (K951630)Organon Teknika Corp.1995-05-08
DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE (K946354)Data Medical Associates, Inc.1995-05-08
SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA) (K950958)Beckman Instruments, Inc.1995-05-08
OSTEOMARK(R) (K945946)Ostex Intl., Inc.1995-05-08
H292 (K942820)Bartels, Inc.1995-05-05
B-L RED(TM) DISCS (K950346)Oxis Intl., Inc.1995-05-05
CAPITOL URINE DRUG SCREEN COLLECTION KIT (K951122)Harry A. Schlakman1995-05-05
AQUALARM MOISTURE SENSOR MODEL P85000 (K946057)Pegasus Research Corp.1995-05-05
CONSENSUS(TM) ORTHOPEDIC DRILL BIT (K950013)U.S. Medical Products, Inc.1995-05-05
EBNA IGG ELISA TEST SYSTEM (K932742)Zeus Scientific, Inc.1995-05-05
LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM (K950431)Open Mri, Inc.1995-05-04
OTOSCOPE A-34 (K950788)Neitz Instruments Company, Ltd.1995-05-03
PREVIEW TELEIMAGING SYSTEM (K950699)Regulatory Management Services1995-05-03
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM (K950784)Advanced Bioresearch Assoc.1995-05-03
JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT (K925469)J.J. Skinner, Inc.1995-05-03
BURR, CORNEAL, BATTERY-POWERED (K950520)Aaron Medical Industries1995-05-02
DISPOSABLE PROPHYLAXIS ANGLE (K951016)Preventive Technologies, Inc.1995-05-02
POWER RANGERS SUNGLASSES (K951008)Siegel,Mandell & Davidson,P.C.1995-05-02
HICHEM Y-GT REAGENT KIT (K946192)Hichem Diagnostics1995-05-02
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K951360)Bayer Corp.1995-05-02
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL (K951435)Aalto Scientific, Ltd.1995-05-02
WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS (K943978)Waters Chromatography Division1995-05-02
MECHANICAL WHEELCHAIR- IMPACT (K945152)Colours 'N Motion1995-05-01
ACCUMETER HDL CHOLESTEROL TEST (K943279)Chemtrak, Inc.1995-05-01
SCIPOTEX (PINK) (K951455)Wembley Rubber Products (M) Sdn Bhd1995-04-28
SCIPOTEX (BLUE) (K951456)Wembley Rubber Products (M) Sdn Bhd1995-04-28
ULTIMAX (K951467)Wembley Rubber Products (M) Sdn Bhd1995-04-28
COMFIT (K951468)Wembley Rubber Products (M) Sdn Bhd1995-04-28
NONE-GENERIC (K940724)Top Fashion Optical & Sunglasses1995-04-28
SUNNEX FASHION CORP. NON-PRESCRIPTION SUNGLASSES (K951504)Sunnex Fashion Corp.1995-04-28
SENSORI-MOTOR RATING SCALE (K946114)Cmed1995-04-28
COMFEEL PLUS CONTOUR DRESSING (K951327)Richard Hamer Assoc., Inc.1995-04-28
SCIPOTEX (K945785)Wembley Rubber Products (M) Sdn Bhd1995-04-28
RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE (K942689)Ranir/Dcp Corp.1995-04-27
RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION (K951378)Resound Corp.1995-04-27
COLGATE PRECISION MINT WZXED DENTAL FLOSS (K944886)Colgate-Palmolive Co.1995-04-27
ORAL-B ULTRAFLOSS WITH FLLUORIDE (K943157)Oral-B Laboratories1995-04-27
VENTIMASK MK IV (K951652)Flexicare Medical, Ltd.1995-04-27
RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (K942690)Ranir/Dcp Corp.1995-04-27
ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE (K942633)Oral-B Laboratories1995-04-27
RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION (K951379)Resound Corp.1995-04-27
IV SHUTTLE (K950367)Equipment Concepts, Inc.1995-04-26
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (K943873)Orthomet, Inc.1995-04-26
X2000 TRADITIONAL WHEELCHAIR (K951351)Homecrest Industries1995-04-26
NATURAL RUBBER LATEX SURGEONS GLOVE (K944053)Arent Fox1995-04-25
Q4.5-5.0PB-4.5 (K951342)Central Solutions, Inc.1995-04-25
CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER (K951123)Micro-Aseptic Products, Inc.1995-04-25
POWDER FREE STERILE LATEX SURGEONS GLOVES (K950468)Intl. Trade Management Co.1995-04-25
BIODERM MEDICAL FOAM WOUND DRESSING (K950619)Bioderm, Inc.1995-04-25
PROSHIELD PLUS MULTIPLE (K946111)Sino (U.S.A.) Co.1995-04-25
POWDER FREE PATIENT EXAMINATION GLOVES (K950467)Intl. Trade Management Co.1995-04-25
MACRO SUCTION TUBE MODEL NO 10061 (K950754)Dlp, Inc.1995-04-25
PHENO-CEN SPRAY DISINFECTANT DEODORANT (K951317)Central Solutions, Inc.1995-04-25
LEUKO-TEST (K951101)Techlab, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN (K945883)Microbiologics, Inc.1995-04-24
NAVARRE UNIVERSAL DRAINAGE CATHETER (K951475)Navarre Biomedical , Ltd.1995-04-24
DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (K951491)Dale Medical Products, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-BILE (K945882)Microbiologics, Inc.1995-04-24
URINE REAGENT STRIPS-8 PARAMETERS (K943436)Teco Diagnostics1995-04-24
LYFO(TM) DIFFERENTIAL DISK-SPS (K945880)Microbiologics, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK (K945881)Microbiologics, Inc.1995-04-24
LYSOL I.C. BRAND DISINFECTANT (K940382)National Laboratories1995-04-21
TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K950353)Miles, Inc.1995-04-20
ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM (K945271)Bio-Chem Laboratory Systems, Inc.1995-04-20
VIGIL MULTICHEK CONTROLS (K951170)Beckman Instruments, Inc.1995-04-20
HP-FAST (K944903)Gi Supply1995-04-20
QUANTITATE ENZYME VERIFIER SET (K951293)Beckman Instruments, Inc.1995-04-20
STAND, INFUSION (K946201)Medical Specialties, Inc.1995-04-18
THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) (K950175)Aqua-Air Medical Devices, Inc.1995-04-18
DIGENE DCR-1 LUMINOMETER (K940486)Digene Diagnostics, Inc.1995-04-18
FRINDLEY ENTERPRISE CO (K942142)Frindley Enterprise Co., Ltd.1995-04-18
NONE-GENERIC (K940725)Yon'S Jay Enterprise Co.1995-04-18
DERMAGRAN HYDROPHILIC OINTMENT (K951499)Derma Sciences, Inc.1995-04-18
SUNGLASSES (K951439)Long Train Enterprise Co., Ltd.1995-04-18
BIPOLAR SNARE (K950776)Cook Urological, Inc.1995-04-18
ULTRACELL ORTHOPEDIC SPONGES (K950372)Ultracell Medical Technologies, Inc.1995-04-17
ULTRACELL ORTHOPEDIC SPONGES (K950370)Ultracell Medical Technologies, Inc.1995-04-17
SPECULUM, ENT (S3) (K951050)Pedia Pals, Inc.1995-04-17
ULTRACELL ORTHOPEDIC SPONGES (K950373)Ultracell Medical Technologies, Inc.1995-04-17
SPECULUM, ENT (S3) (K951049)Pedia Pals, Inc.1995-04-17
RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS) (K951560)Radius Intl., Inc.1995-04-17
DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (K951345)Catheter Research, Inc.1995-04-14
PREMIER EHEC (K950167)Meridian Diagnostics, Inc.1995-04-14
MULTIPLE (IZON DBS & URINE COLLECTION KIT) (K950257)Izon Business Products, Inc.1995-04-14
NITE-GUIDE (K931615)ORTHO-TAIN, Inc.1995-04-14
RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION (K951376)Resound Corp.1995-04-14
STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA (K950308)Solarcare Technologies Corp,Inc.1995-04-14
RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION (K951377)Resound Corp.1995-04-14
RESOUND PERSONAL HEARING SYSTEM ED3/S-E (K951375)Resound Corp.1995-04-14
OXYGEN REGULATOR (K950777)Mada Medical Products, Inc.1995-04-14
RESOUND PERSONAL HEARING SYSTEM BT2/S-E (K951374)Resound Corp.1995-04-14
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR (K950164)Abaxis, Inc.1995-04-13
TACTYLON(TM) POWDER FREE SURGEONS GLOVE (K950185)Tactyl Technologies, Inc.1995-04-13
SPINAL MARKER (K944188)Leibinger L.P.1995-04-13
COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) (K951137)Wembley Rubber Products (M) Sdn Bhd1995-04-13
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