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

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RecordFirmDate
DISPOSABLE MICROSTAAR INJECTOR (K940593)Staar Sugical1994-09-19
POWDER FREE EXAMINATION GLOVES (K932550)Unigloves , Ltd.1994-09-19
MICRO X-80 HF (K944149)Fischer Imaging Corp.1994-09-16
EPISTAT-II NASAL CATHETER (K943718)Merocel Corp.1994-09-16
MICRO X-50 HF (K944147)Fischer Imaging Corp.1994-09-16
THE BLENDTONE ROYALE (K943398)Instantron1994-09-16
PROSHIELD PLUS MULTIPLE GLOVES (K943735)Sino (U.S.A.) Co.1994-09-16
THE ELITE SPECTRUM (K943396)Instantron1994-09-16
MICRO X-30HF (K944148)Fischer Imaging Corp.1994-09-16
LOWER BODY CYCLES (K935061)Biodex Medical Systems, Inc.1994-09-16
ALL-IN-THE-EAR (K943318)Golden State Audiology Assoc.1994-09-16
SOPHOS DENTAL DIAMOND (K943841)Sophos Technologic1994-09-16
MICRO X-65 HF (K944150)Fischer Imaging Corp.1994-09-16
UPPER BODY CYCLES (110 VOLT)/(220 VOLT) (K935520)Biodex Medical Systems, Inc.1994-09-16
THE SS-99 (K943399)Instantron1994-09-16
SEMI-RECUMBENT CYCLES (K935216)Biodex Medical Systems, Inc.1994-09-16
BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT (K943754)Bionostics, Inc.1994-09-14
NIDA-5/RT, DRUG OF ABUSE CONTROLS (K942041)Meditech1994-09-14
SUNGLASSES (K943562)Australian Optical Co., Inc.1994-09-14
IV START KITS (K943047)Sterile Concepts, Inc.1994-09-14
SPECTACLE FRAME (K943561)Australian Optical Co., Inc.1994-09-14
BILIRUBIN PLUS/PEDIATRIC CONTROLS (K943290)Medi-Tech, Inc.1994-09-14
SUNGLASSES (K940421)Double Hero Corp.1994-09-14
SUNGLASS CLIP (K943640)Australian Optical Co., Inc.1994-09-14
MIRAGE EYEWEAR INC. (K944026)Mirage Eyewear, Inc.1994-09-14
NIL (K943963)Max-Vision (H.K.)Limited1994-09-14
NIL (K944108)Micron Metal & Plastic Manufactory Co.1994-09-14
SPECTACLE FRAME (K943641)Australian Optical Co., Inc.1994-09-14
ILO MADE IN ITALY; GARBO HAND FINISHED ITALY (K943296)Ilo Industria Lombarda Ottica Srl1994-09-14
OPERA SYSTEM (K943376)Miles, Inc.1994-09-14
DOA-PLUS, DRUGS OF ABUSE CONTROLS (K942257)Medical Diagnostic Technologies, Inc.1994-09-14
SPECTACLE FRAMES (K943792)Kt Optique, Inc.1994-09-14
SWABZYME OXIDASE (K934130)E-Y Laboratories, Inc.1994-09-14
NIL (K944109)Keep Top Intl., Ltd.1994-09-14
DAB WELDLESS WHEELCHAIR (K944122)Da Intl. , Ltd.1994-09-13
DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME (K944194)Med-Tek Innovations, Inc.1994-09-13
THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED (K942552)Medi-Tech, Inc.1994-09-09
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (K943182)Oral-B Laboratories1994-09-09
TNT TROPONIN T (K942632)Streck Laboratories, Inc.1994-09-09
E-VAC-U-ACCESSORIES (K942520)Bull Frog Mfg. Co.1994-09-09
MICRO-TOUCH LATEX MEDICAL GLOVES (K943620)Johnson & Johnson Medical, Inc.1994-09-09
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 (K940679)Helena Laboratories1994-09-09
PLASMINOGEN RID TEST KIT (K941346)The Binding Site, Ltd.1994-09-09
AMSCO STERILE RECOVERIES SURGICAL PACKS (K932522)Amsco Sterile Recoveries, Inc.1994-09-09
B-LACTAMASE REAGENT TUBES (K940161)E-Y Laboratories, Inc.1994-09-09
GONOCHEK-II, MODIFICATION (K934125)E-Y Laboratories, Inc.1994-09-09
CULTURIA MACCONKEY-MUG (K934759)Clinical Convenience Products, Inc.1994-09-09
GONOCHEK II REAGENT TUBES (K940162)E-Y Laboratories, Inc.1994-09-09
COMBO MASK (K941336)Gam Industries, Inc.1994-09-09
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT (K942638)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-09-07
MAX FRAME DESIGN (K943913)Noble Optic1994-09-07
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT (K941168)Incstar Corp.1994-09-07
INFINITY 252 (K935019)Siemens Hearing Instruments, Inc.1994-09-07
HUMAN IGG SUBCLASSES ELISA COMBI KIT (K943098)Research Diagnostics, Inc.1994-09-07
HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (K943205)Research Diagnostics, Inc.1994-09-07
VENTANA EMA PRIMARY ANDIBODY (K940243)Ventana Medical Systems, Inc.1994-09-07
HALL MICROCHOICE ELECTRIC POWERED SYSTEM (K942660)Hall Surgical, Division of Zimmer, Inc.1994-09-07
SIEMENS MODEL 584 P-2 (K934752)Siemens Hearing Instruments, Inc.1994-09-07
SPECTACLE FRAMES (K943423)Galilee Optics1994-09-06
MODULE PROGRAM (K942722)Electone, Inc.1994-09-06
PBI PLUS HDL PRECIPITATING REAGENT (K941744)Merchant House Scientific1994-09-06
SUNGLASSES (K942322)Suntory Industrial Co.1994-09-06
SPECTACLE FRAMES (K943039)Rodenstock USA Inc.,1994-09-06
PNEUMATIC WIRE TENSIONER (K942760)Smith & Nephew Richards, Inc.1994-09-06
DELFIA SHBG KIT (K940449)Wallac OY1994-09-06
BODY BOOT (K940723)Mark-Clark1994-09-06
(BRAND NAME0 MONDAIN (K943840)Chan'S Plastic Manufactory Co., Ltd.1994-09-06
PEMBUSH (K942634)Crossroads Trading Co.1994-09-02
ROCHE TDM CALIBRATION VERIFICATION TEST SET (K942114)Roche Diagnostic Systems, Inc.1994-09-02
AUTO REF-KERATOMETER, RK-3 (K942242)Cannon U.S.A., Inc.1994-09-02
4 CHANNEL DISPENSER (K942655)Tecan U.S., Inc.1994-09-02
FRAME SPECTACLE (K943753)Optic Tech Corp.1994-09-02
EXMOOR SINGLE USE MYRINGOTOMES (K942745)Exmoor Plastics , Ltd.1994-09-02
MODEL 2600 PROCART (K941476)Compressor Technologies, Ltd.1994-09-02
RANIR PLAX RX (K935906)Ranir/Dcp Corp.1994-09-02
SUNGLASSES (K941726)Yowmost Enterprise Co., Ltd.1994-09-02
TOTAL KNEE KIT (K932918)Biodynamic Technologies, Inc.1994-09-01
CLINICAL BLOOD GAS MIXTURE (K942866)Nordan Smith Welding Supplies1994-09-01
JEMSDAL MASK (K942907)Respan Products, Inc.1994-08-31
AG-839PA CO2 MODULE AND ACCESSORIES (K944027)Nihon Kohden America, Inc.1994-08-31
BACT/ALERT FAN AEROBIC CULTURE BOTTLE (K935711)Organon Teknika Corp.1994-08-30
DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS (K940908)Dunhall Pharmaceuticals, Inc.1994-08-29
OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (K925606)Chiron Vision Corp.1994-08-29
STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY (K931731)Storz Instrument Co.1994-08-29
SUNGLASSES (K943677)Jenn Wei Glass Company, Ltd.1994-08-29
SUNGLASSES (K943912)Kason Enterprises Limited1994-08-29
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE (K936271)Diagnostic Hybrids, Inc.1994-08-26
STREP-A-CHEK(TM) REAGENT STRIPS (K940020)E-Y Laboratories, Inc.1994-08-26
APEX DISPOSABLE INSTRUMENTS (K941907)Apex Ent., Inc.1994-08-26
HYPERFLEX FLEXIBLE GUIDEWIRES (K941711)Linvatec Corp.1994-08-26
AURAFLEX SYSTEMS (K942443)Organon Teknika Corp.1994-08-26
STAR I WORKSTATION (K942290)Standard Engineering1994-08-26
EY-20 REAGENT TUBES (K940124)E-Y Laboratories, Inc.1994-08-26
CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET (K942284)Creative Laboratory Products, Inc.1994-08-26
STREP-A-CHEK (K934129)E-Y Laboratories, Inc.1994-08-26
PRESSURE INFUSION CUFF (K942933)Circulatory Technology, Inc.1994-08-25
DEEP SUTURE (K942818)Automated Medical Products Corp.1994-08-25
VIDEOTOSCOPE (K943916)Welch Allyn, Inc.1994-08-25
ARTHREX CIRCULAR HARVESTING SAW (K941681)Arthrex, Inc.1994-08-25
MICROGENICS THC CONTROL SETS (K943048)Microgenics Corp.1994-08-24
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