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

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RecordFirmDate
MULTIFOCUS COMPACT BTE HEARING AID (K933307)Oticon, Inc.1993-08-23
WIDEX MODEL LOGO 8 (L8) (K933644)Widex Hearing Aid Co., Inc.1993-08-23
WIDEX MODEL LOGO 12 (L12) (K933640)Widex Hearing Aid Co., Inc.1993-08-23
CORDIS TUNNELER (K932273)Cordis Corp.1993-08-23
WIDEX MODEL LOGO 6 (L6) (K933643)Widex Hearing Aid Co., Inc.1993-08-23
HALUX TASKLIGHT (K931645)Burton Medical Products Corp.1993-08-20
MEDWAY OXYGEN MASK (K931952)Medway1993-08-20
NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (K932147)Hans Rudolph, Inc.1993-08-20
MI-4 VARIABLE SPOT LIGHT (K931646)Medical Illumination, Inc.1993-08-19
MI-5 DIAGNOSTIC LIGHT (K931026)Medical Illumination, Inc.1993-08-19
CALIBRATION GAS (K932520)Cryodyne Technologies, Inc.1993-08-19
MICRINS CONTRAST BACKGROUND MATERIAL (K933310)Micrins Surgical, Inc.1993-08-19
OMNI (K925625)Bio-Tek Instruments, Inc.1993-08-19
BELTONE PRIMA 2000 (K932703)Beltone Electronics Corp.1993-08-19
SENSICARE POWDER FREE MEDICAL GLOVE (K925244)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-08-19
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM (K932674)Miles Inc., Dental Products1993-08-19
ISI FENESTRATED DISSECTING AND GRASPING FORCEPS (K932534)Innovative Surgical, Inc.1993-08-19
COBAS CORE PROLACTIN EIA (K930305)Roche Diagnostic Systems, Inc.1993-08-19
EASY-ON (K932998)Devon Industries, Inc.1993-08-18
ACTION MEDTEK FACE SHIELD (K926438)Action Eyewear Corp.1993-08-18
SOLSTAR BRILLENMODE SUNGLASSES (K930562)Solstar Produktions GmbH1993-08-17
MEROCEL MEROSPLINT (K933152)Merocel Corp.1993-08-17
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) (K931773)King Diagnostics, Inc.1993-08-16
3M MODEL 200RT RATE TAPER INFUSION PUMP (K926059)3M Health Care, Ltd.1993-08-16
COTUBE ESTRADIOL RADIOIMMUNOASSAY (K931740)Bio-Rad1993-08-16
IMMULITE TSH THIRD GENERATION CONTROL (K930007)Diagnostic Products Corp.1993-08-16
POWDERED EXAMINATION GLOVES (K930995)P.T. Healthcare Glovindo1993-08-16
3M MODEL 280RT RATE TAPER INFUSION PUMP (K926058)3M Health Care, Ltd.1993-08-16
APO A-1 CHEMILUMINESCENCE ASSAY (K931777)Nichols Institute1993-08-16
SUPERSTAND 3000 (K933253)Wuestec Medical, Inc.1993-08-16
BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS (K930238)Prolac, Inc.1993-08-16
POOLE TIP SUCTION PROBE (K931950)Mayaguez Medical Center1993-08-11
URESIL ABSCESS DRIANAGE AND IRRIGATION SET (K925117)Uresil Corp.1993-08-11
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 (K933317)Bio-Rad1993-08-11
IRRIGATING BLUNT DISSECTOR (K931912)Mayaguez Medical Center1993-08-10
STAPH-A-LEX(TM) SYSTEM (K926173)Trinity Laboratories, Inc.1993-08-10
PYRAMID SUNGLASSES/PYRAMID READING GLASSES (K931328)Pyramid1993-08-10
SURESEAL BANDAGE (K922441)Gainor Medical Europe, Ltd.1993-08-10
OUT FOR FUN! HAPPY MEAL MCDONALDLAND SUNGLASSES (K932018)Simon Marketing, Inc.1993-08-10
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER (K932228)Boston Scientific Corp1993-08-10
UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG (K924689)United Biotech, Inc.1993-08-10
5.0 MM IRRIGATION/ASPIRATION PROBE (K931856)Mayaguez Medical Center1993-08-10
PRIZM HEARING SYSTEM (K930909)Audioscience, Inc.1993-08-09
SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND (K932265)Symbiosis Corp.1993-08-09
ADHESIVE BANDAGES (K932602)Aso Corp.1993-08-09
SAW BLADE (K933298)Omega Surgical Instruments, Inc.1993-08-09
WELLS LAMONT HANDAGES/MED WRAP DRESSINGS (K925937)Wells Lamont Corp.1993-08-09
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA (K923903)Biomerieux Vitek, Inc.1993-08-09
SUNGLASSES (K931525)Premiums Promotions & Imports, Inc.1993-08-09
MARCO STANDARD KERATOMETERS (K930444)Marco Ophthalmic, Inc.1993-08-09
MARCO STANDARD RADIUSGAUGES (K930437)Marco Ophthalmic, Inc.1993-08-09
OTT SUNGLASSES (K932135)Sunnex Fashion Corp.1993-08-06
CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM (K932722)Carie Med-Tech Services, Inc.1993-08-06
ALTA DRESSING FRAME (K926380)Alta Medical Products, Inc.1993-08-06
MEROCEL WOUND DRESSING (K931565)Merocel Corp.1993-08-06
SUTURE REMOVING FORCEPS (K932385)Rocket of London, Ltd.1993-08-06
REAMER BIT (K930339)Neoligaments, Ltd.1993-08-06
SANITAS PATIENT SCALE (K930626)Dutton-Lainson Co.1993-08-06
THOROCOSCOPY SELF-RETAINING RETRACTOR (K926585)T. Korossurgical Instruments Corp.1993-08-06
3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X (K930468)3M Health Care, Ltd.1993-08-06
MEDDRAINS (K931607)Armm, Inc.1993-08-06
POWDERFREE NATURAL LATEX GLOVES (K921389)Arista Latindo Industrial Ltd. P.T1993-08-05
OTICON MF (K932670)Oticon Corp.1993-08-05
EYEGLASS FRAMES AND SUNGLASSES (K926065)Palm Optical Co., Inc.1993-08-05
SPECTACLE FRAMES (K931648)Eye Care Centers of America, Inc.1993-08-05
DADE(R) TUMOR MARKER CONTROL (K924919)Baxter Diagnostics, Inc.1993-08-05
CENTRICON -50 CONCENTRATOR (K930168)Amicon, Inc.1993-08-05
QUANTEM (TM) (K932957)GE Medical Systems1993-08-05
DELFIA TESTTOSTERONE KIT (K932951)Wallac OY1993-08-03
PATIENT EXAMINATION GLOVE (K924556)Cenland Industries Sdn Bhd1993-08-03
OTOSCOPE (K925758)Rudolf Riester GmbH & Co. KG1993-08-03
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS) (K932729)Eastman Kodak Company1993-08-03
REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 (K930317)Helena Laboratories1993-08-03
IAB ANCHOR (K922103)Datascope Corp.1993-08-03
DISETRONIC DOLOMAT PUMP (K920063)Disetronic Medical Systems1993-08-03
ABUSCREEN ONLINE CONTROL (K931125)Roche Diagnostic Systems, Inc.1993-08-03
GOLD AF MODULE, ITE (K933038)Electone, Inc.1993-08-02
SILVER COMPRESSION MODULE, ITE (K933042)Electone, Inc.1993-08-02
ALTAIR EYEWEAR FRAMES (K931135)Altair Eyewear1993-08-02
O'BRIEN GONIOMETER (K926237)Sgarlato Laboratories, Inc.1993-08-02
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY (K932955)Ciba Corning Diagnostics Corp.1993-08-02
GOLD CD MODULE, ITE (K933040)Electone, Inc.1993-08-02
SILVER RECHARGEABLE MODULE, ITE (K933045)Electone, Inc.1993-08-02
DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET (K932870)Casco Standards1993-08-02
SPECTACLE FRAMES (K930597)Venis DI Alessandro Vendrame1993-08-02
SILVER L MODULE, ITE (K933046)Electone, Inc.1993-08-02
GOLD ASP MODULE, ITE (K933036)Electone, Inc.1993-08-02
SILVER PPP MODULE, ITE (K933043)Electone, Inc.1993-08-02
SPECTACLE FRAMES (K933133)Solitaire Designs, Ltd.1993-08-02
GOLD L MODULE, ITE (K933039)Electone, Inc.1993-08-02
GOLD K AMP, ITE (K933037)Electone, Inc.1993-08-02
SILVER LD MODULE, ITE (K933044)Electone, Inc.1993-08-02
ELECTRIC WIRE DRIVER, MODEL 2640E (K930205)Micro Surgical Instruments Corp.1993-08-02
WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) (K931037)Whitmore Ent., Inc.1993-07-30
ARGYLE ASPIR-FLEX SUCTION CATHETER (K925556)Sherwood Medical Co.1993-07-30
PERI-K PAD COLD PACK (K920760)Baxter Healthcare Corp1993-07-29
MULTIVIEW FOR WINDOWS (K931292)Image Data Corp.1993-07-29
A.J. MORGAN SUNGLASSES (K925803)A.J. Morgan Ent.1993-07-29
TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3 (K931366)Medical Analysis Systems, Inc.1993-07-28
CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3 (K932658)More Diagnostics1993-07-28
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