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

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RecordFirmDate
HILO TABLE (K933621)Spinalight, Inc.1994-01-07
BASIC TILT CHAIR ( BTC ) (K934418)Labac Systems, Inc.1994-01-07
COMFIT BLUE POWDER FREE EXAMINATION GLOVE (K934813)Wembley Rubber Products (M) Sdn Bhd1994-01-07
COMFIT GREEN POWDER FREE EXAMINATION GLOVE (K934812)Wembley Rubber Products (M) Sdn Bhd1994-01-07
PATIENT EXAMINATION GLOVE (K934942)P.T. Surya Milani Plastic Utama1994-01-07
FLEXION DISTRACTION TABLE (K933622)Spinalight, Inc.1994-01-07
POWDER FREE LATEX EXAMINATION GLOVES (K934345)Vas Latex Co. , Ltd.1994-01-07
POWDER-FREE LATEX EXAMINATION GLOVE (K934546)Powercrest (M) Sdn. Bhd.1994-01-07
POWERED SURGICAL INSTRUMENT ACCESSORY (K930363)Intenn Engineering, Inc.1994-01-07
PRECISION INTRA-ORAL SCOPES (K932878)Precise Optics1994-01-06
A-DEC 2544 DOCTORS IC MICRO-CART (K925797)A-Dec, Inc.1994-01-06
SILON SILICONE GEL SHEET (K932214)Bio Med Sciences, Inc.1994-01-06
SUNGLASSES (K934020)Sun Probe Enterprise Co., Ltd.1994-01-06
VISUAL SCENE SUNGLASSES (K932469)Vsi Intl., Inc.1994-01-06
BIKER MICE SUNGLASSES (K935165)Ja-Ru, Inc.1994-01-06
A-DEC 2545 DUO IC MICRO-CART (K925798)A-Dec, Inc.1994-01-06
GLENROE ELASTIBITE STIMULATOR (K924351)Glenroe Technologies1994-01-06
SUNGLASSES (K935541)Seven Pyramid Ent Co., Ltd.1994-01-06
FINE OPTICS SUNGLASSES (K933938)Fine Optics, Inc.1994-01-06
OPHTHALMIC TRIAL LENSES (K930195)Optimark Accessories and Instruments1994-01-06
WILEY/ESPOSITO DENTAL GUARD (K935713)Fvtnks1994-01-05
PRISM BONE CEMENT MIXING SYSTEM (K925025)Depuy, Inc.1994-01-05
AUDIPHON, MODEL H-11 (K935458)National Hearing Aid Dist., Inc.1994-01-05
LC DENTAL HAND INSTRUMENT (K935217)L.C. Dental1994-01-05
IMPAX 5000 (K934386)Heraeus Kulzer, Inc.1994-01-05
SPECTACLE FRAMES (K932439)Styl-Rite Optics, Inc.1994-01-03
RHABDOMYOSARCOMA CELLS (K935337)Advanced Clinical Diagnostics1994-01-03
FLOATS SUNGLASSES (K932151)Floats, Inc.1994-01-03
NICKEL-TITANIUM K-TYPE FILE (K935542)Union Broach, Div. Moyco Industries, Inc.1994-01-03
NONREBREATHING VALVE (K933583)Hans Rudolph, Inc.1994-01-03
HELA HELA EPITHELOID CARCINOMA (K935339)Advanced Clinical Diagnostics1994-01-03
HUMAN LUNG DIPLOID CELLS-MRC-5 (K934244)Advanced Clinical Diagnostics1994-01-03
IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM (K935287)Miles, Inc.1994-01-03
ERCP CATHETER, HYDROPHILIC COATED (K932205)Wilson-Cook Medical, Inc.1994-01-03
HUMAN FORESKIN FIBROBLAST CELLS-H.F.F. (K934245)Advanced Clinical Diagnostics1994-01-03
ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT (K921868)Endocrine Sciences Products1994-01-03
KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO (K934240)Advanced Clinical Diagnostics1994-01-03
LUNG DIPLOID HUMAN CELLS-WI-38 (K934246)Advanced Clinical Diagnostics1994-01-03
LUNG CACINOMA, HUMAN CELLS (K935338)Advanced Clinical Diagnostics1994-01-03
BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K. (K934242)Advanced Clinical Diagnostics1994-01-03
KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1 (K934239)Advanced Clinical Diagnostics1994-01-03
HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 (K934243)Advanced Clinical Diagnostics1994-01-03
MCCOY CULTURE CELLS-MCCOY (K934241)Advanced Clinical Diagnostics1994-01-03
CYNOMOLOGUS MONKEY KIDNEY CELLS (K935336)Advanced Clinical Diagnostics1994-01-03
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II (K935230)Syva Co.1994-01-03
VACVENT (K931873)Steven Frank Mercereau1993-12-30
LAKE OSTOMY CARE SET (K922730)Lake Medical Products, Inc.1993-12-30
BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS (K934062)Biotrack, Inc.1993-12-29
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET (K934923)Unipath , Ltd.1993-12-29
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET (K934922)Unipath , Ltd.1993-12-29
OLYMPIC AUTO-LENGTH (K934930)Olympic Medical Corp.1993-12-29
MAXIVIEW DIAGNOSTIC WORKSTATION (K930500)Dimensional Medicine, Inc.1993-12-29
PARA 4 PLUS (K933844)Streck Laboratories, Inc.1993-12-27
IDEIA(TM) ROTAVIRUS (K932384)Dako Diagnostics , Ltd.1993-12-27
MICRO-TECH TRU CANAL (K934149)Micro-Ear Technology, Inc.1993-12-27
3M TEGADERM HP TRANSPARENT DRESSING (K932422)3M Health Care, Ltd.1993-12-27
EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN (K926230)Convatec, A Division of E.R. Squibb & Sons1993-12-23
SABA INTIMA (K924176)Scott Paper Co.1993-12-23
CONFORT (K924177)Scott Paper , Ltd.1993-12-23
SABA CONFORT (K924175)Scott Paper Co.1993-12-23
GOODMAN BANDAGE (K933085)Megadyne Medical Products, Inc.1993-12-23
CHEMOSITE IMPLANTABLE DRUG DELIVERY (K930632)Device Labs, Inc.1993-12-22
ENDO-JUDGE (K932591)Synergistic Medical Technologies, Inc.1993-12-22
MESALT STERILE DRESSING (K934839)Richard Hamer Assoc., Inc.1993-12-22
GH GLOVES (POWERED) (K934047)Grafik Hersteller Sdn Bhd1993-12-22
PRO FIT-CYBER II OPTION (K935289)Qualitone1993-12-22
ROYAL SHIELD SHIELD GLOVES (K926132)Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.1993-12-22
GH GLOVES (POWDER FREE) (K934048)Grafik Hersteller Sdn Bhd1993-12-22
POWDER-FREE LATEX EXAMINATION GLOVES (K924906)Jentera Jaya Sdn Bhd1993-12-22
ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC (K932665)Smith & Nephew Perry1993-12-22
CALSSIQUE OR MYSTIQUE (K932978)Dekumed, Kunststofftechnik Degler GmbH1993-12-22
ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA (K932664)Smith & Nephew Perry1993-12-22
CLINICAL BLOOD GAS (K935311)Acetylene Gas Co.1993-12-22
CONTACT LENSES (K934859)Arno Intl., Inc.1993-12-21
RUSSELL & HANCOCK 524 AND 422 SUNGLASSES (K933323)Russell & Hancock, Ltd.1993-12-21
EMDS PHOSPHOROUS (PHOS) TEST (K935178)Em Diagnostic Systems, Inc.1993-12-17
CLASSIQUE (K932899)Hemispheres Marketing Co. , Ltd.1993-12-16
BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE (K931487)Bird Life Design1993-12-16
CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (K935136)Em Diagnostic Systems, Inc.1993-12-16
BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE (K934084)Bioenterics Corp.1993-12-16
IRON TEST (K935176)Em Diagnostic Systems, Inc.1993-12-16
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (K935177)Em Diagnostic Systems, Inc.1993-12-16
PYR TEST KIT (K931865)Hardy Diagnostics1993-12-15
PAL (PERSONAL AMPLIFIER FOR LISTENING) (K933963)Hearing Care Products, Inc.1993-12-15
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS (K935095)3M Company1993-12-15
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE (K932259)Clarus Medical Systems, Inc.1993-12-15
MIRACLE EAR MODEL SHARP II CANAL (K935265)Miracle-Ear, Inc.1993-12-15
MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID (K935266)Miracle-Ear, Inc.1993-12-15
ACTION WIZARD PEDIATRIC MANUAL WHEELCHAIR (K934646)Invacare Corp.1993-12-15
SOUNDRIGHT, SHP (K935420)Soundright Hearing Products1993-12-15
CARAPACE STERILE CAST PADDING (K931672)Carapace, Inc.1993-12-15
FORCEPS, BIOPSY, GASTROINTESTINAL (K934186)Primed Instruments, Inc.1993-12-14
KAWASUMI LABORATORIES K-CUFF (K930012)Kawasumi Laboratories Co., Ltd.1993-12-14
MODEL ALPHA TS-2 (K935004)Dpa Consulting, Inc.1993-12-13
PULSE ELECTRIC TOOTHBRUSH (K933829)Dentatech Corp.1993-12-13
SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR (K934967)Shimadzu Corp.1993-12-13
MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING (K933689)Kendall Healthcare Products Co. Div.Of Tyco Health1993-12-13
CONCEPT ONE (K933777)Innerscan, Inc.1993-12-13
RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM (K934519)Medtec, Inc.1993-12-13
RADIOGRAPHIC GENERATOR HFQ-WHIS (K935068)Bennett X-Ray Corp.1993-12-13
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