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

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RecordFirmDate
EVACUATOR, ORAL CAVITY (K932824)Den-Tal-Ez Mfg Co., Inc.1993-09-28
VITAPEN (K924447)Vitajet Corp.1993-09-27
EZ PUMP (K926446)Alphamed, Inc.1993-09-27
URIC ACID TEST ITEM NUMBER 65422 (K932162)Em Diagnostic Systems, Inc.1993-09-27
BIOCLOT LA (K932463)Biopool AB1993-09-27
DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2 (K933435)Baxter Diagnostics, Inc.1993-09-24
SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES (K933744)Sa Scientific, Inc.1993-09-24
A MANO TONGUE CLEANSER (K932839)A Mano Products, Ltd.1993-09-23
OMNI-MATRIX (K930151)Innovative Technology , Ltd.1993-09-23
LATEX EXAMINATION GLOVE (K930557)Ezmt Valve Co., Inc.1993-09-23
MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT (K931197)Meddev International Corp.1993-09-23
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (K926002)Alamar Biosciences Laboratory, Inc.1993-09-23
ANTI-DISCONNECTION MECHANISM (K933781)Hammer-Plane, Inc.1993-09-22
COBAS CORE FSH EIA (K930304)Roche Diagnostic Systems, Inc.1993-09-21
AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES (K932178)Tosoh Medics, Inc.1993-09-21
ACE CLINICAL CHEMISTRY SYSTEM (K931786)Schiapparelli Biosystems, Inc.1993-09-21
SPECTACLE FRAME (K933874)Designer Frames1993-09-20
STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN (K933424)Zyloware Corp.1993-09-20
COURIER PC (K925864)Shoreline Business Consulting1993-09-20
SPECTACLE FRAMES (K930435)Venis DI A. Vendrame1993-09-20
ORTHODONTIC ELASTOMER (K932319)Gac Intl., Inc.1993-09-20
FRAMES, SPECTACLES (K932772)Optical Designs and Sourcing, Inc.1993-09-20
FRAMES, SPECTACLES (K932773)Diaco, Inc.1993-09-20
SUNGLASSES (K933074)P.T. Sun and Young Indonesia Sunglasses1993-09-20
ROLLENS POST-MYDRIATIC SUNGLASS (K932646)Rollens Professional Products, Inc.1993-09-20
STETSON/S.LOREN/LH.BAZAAR/G.VANDERBILT/P.BALMAIN (K933423)Thunder Industries, Inc.1993-09-20
MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL (K933098)Siemens Medical Solutions Health Services Corporat1993-09-20
SUNGLASSES (K925428)Dallas Handbag Co.1993-09-20
EYEGLASS FRAMES (K933254)Sam Chung Optical Co., Ltd.1993-09-20
NON-PRESCRIPTION SUNGLASSES (K926096)Lunettes Bondet1993-09-20
SUNGLASSES (K932939)Soft-Ray Optical Corp.1993-09-20
MULTIPLE (K933616)Greg and Greg, Inc.1993-09-20
SUNGLASSES (K932940)Sun and Young Sunglasses Co., Ltd.1993-09-20
WATER PIK PLUS PLAQUE CONTROL SYSTEM (K931380)Teledyne Water Pik1993-09-20
MARCHON/MARCOLIN SUNGLASSES (K933734)Marchon Eyewear, Inc.1993-09-20
SUNGLASSES (K932941)Rayman Speco Co., Ltd.1993-09-20
SPIRIT SHIELD (K931718)Eaton Medical Corp.1993-09-20
NON-PRESCRIPTION SUGLASSES (K932814)Sun Style Intl. Corp.1993-09-20
SUNGLASSES (K931504)The B & F System, Inc.1993-09-20
AS-90 (K923006)Qualitone1993-09-18
INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (K933170)Inman Medical Corp.1993-09-16
THE INFANT FLOW SYSTEM (K930713)Sechrist Industries, Inc.1993-09-16
APPLICATOR NOZZLE (K926368)Centrix, Inc.1993-09-15
PLASTIC CHAIN (K925012)American Orthodontics1993-09-13
RELAX-O-GUARD (K925064)Aquatemp Service Co., Inc.1993-09-13
ION-IMPLANTED NEO SENTALLOY (K932025)Gac Intl., Inc.1993-09-13
NITANIUM PALATAL EXPANDER (K923218)Ortho Organizers, Inc.1993-09-13
SANITAS PATIENT LIFT (K930625)Dutton-Lainson Co.1993-09-13
MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION (K932743)Scott Health Care1993-09-10
PRO-SCOPE MODEL # PS-4000 (K922942)Pro-Den Systems, Inc.1993-09-10
REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE (K933557)Consolidated Technologies, Inc.1993-09-10
PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (K930606)Pudenz-Schulte Medical Research Corp.1993-09-10
FISK ARM SUPPORT (K931876)Vvortex International Corp.1993-09-09
PATIENT EXAMINATION GLOVES (K926318)I Ching Ent., Inc.1993-09-09
SPECTACLE FRAME (K932802)Insight Optical Mfg. Co. of Florida, Inc.1993-09-09
NEW STAR, TAE HAN OPTICAL (K932999)J.B. Eyewear, Inc.1993-09-09
FRAME, SPECTACLE (K933436)Aoyama Optical Co., Ltd.1993-09-09
SPECTACLE FRAMES (K933313)Serrao Optical Intl., Inc.1993-09-09
UIBC FOR DISCREET RANDOM ACCESS ANALYZER (K932871)Catachem, Inc.1993-09-08
SYNERMED GGT REAGENT KIT (K931958)Synermed, Inc.1993-09-08
OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT (K931835)Olympus Corp.1993-09-08
OPUS ESTRADIOL (K933066)Pb Diagnostic Systems, Inc.1993-09-08
PROFAST(R)-DENTURE CLEANSER (K930337)Fittydent-Altwirth & Schmitt GmbH1993-09-07
THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME (K932153)Biodan Medical Systems, Ltd.1993-09-07
HM-0970 (K932720)Hill-Med, Inc.1993-09-07
ES-100 POWER SYSTEM, ES-100 SERIES (K925360)Elekta Instruments, Inc.1993-09-07
POLYDOROS IS (K933240)Siemens Medical Solutions USA, Inc.1993-09-07
TISSUE ISOLATION AND RETRIEVAL BAG (K931886)Advanced Surgical, Inc.1993-09-07
PHILIPS 45 SERIES (K933850)Philips Hearing Instruments Co.1993-09-07
POYDOROS LX (K931930)Siemens Medical Solutions USA, Inc.1993-09-07
FIBEROPTIC LIGHTSOURCES AND CARRIERS (K933145)Electro Fiberoptics Corp.1993-09-07
PMT(R) SILICONE GEL SHEETING MODEL 3505-1 (K930409)Pmt Corp.1993-09-01
AMNIOTEST(TM) (K914419)Pro-Lab, Inc.1993-09-01
BECKMAN VIGIL PLUS CONTROL (K930850)Beckman Instruments, Inc.1993-09-01
U108, U105, G209-B (K925224)Custom Optical Frames, Inc.1993-09-01
STAINLESS STEEL ORTHODONTIC PRODUCTS (K931980)Ortho Organizers, Inc.1993-09-01
UNIQUET (K931198)Icat Systems1993-09-01
SPECTACLE FRAMES (K933280)U.S. Optical1993-08-31
FRAMES, SPECTACLE (K932813)Rainbow Optics, Inc.1993-08-31
MSP OPHTHALMIC (EYE SPUD) (K931449)Medical Sterile Products, Inc.1993-08-31
OLYMPUS REPLY GLUCOSE REAGENT (K931744)Olympus Corp.1993-08-31
SPECTACLE FRAMES (K932906)U.S. Optics, Inc.1993-08-31
GM SWIVEL VIDEO (TM) IRRIGATOR (K931398)Gm Engineering, Inc.1993-08-30
I.V. START KIT (AHC-50-54954 (K924192)American Healthcare Corp.1993-08-27
PRO-FLO SYSTEM (K931896)Lafayette Pharmacal, Inc.1993-08-26
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS (K932549)Roche Diagnostic Systems, Inc.1993-08-26
DENRICK SPEECH AID (DR-1) (K931371)Denrick Corp.1993-08-25
TRIGLYCERIDES (K931891)Em Diagnostic Systems, Inc.1993-08-25
PROBE PERSONAL PREFERENCE NON-STER. PAT. EXAM.GLOV (K930903)Glove India Private , Ltd.1993-08-25
POWDER-FREE LATEX EXAMINATION GLOVES (K930407)Influx Pacific Sdn. Bhd.1993-08-25
MODISSA 90 S.R.L. SPECTACLE FRAMES (K930857)Modissa 90 Srl1993-08-25
LANGGASSE 90 (K932470)Happersberger Otopront GmbH1993-08-25
LATEX EXAMINATION GLOVES (POWDER FREE) (K926526)Rantran, Inc.1993-08-24
MEDCAM (K925967)Medcam USA, Inc.1993-08-24
PROFAST(R)-DENTURE ADHESIVE CREAM (K930336)Fittydent-Altwirth & Schmitt GmbH1993-08-24
HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES (K930139)Shun Thai Rubber Gloves Industry Co., Ltd.1993-08-24
LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) (K930198)Forda (China) Optical Co.1993-08-23
SYNELISA TG ANTIBODIES/TPO ANTIBODIES (K933123)Elias U.S.A., Inc.1993-08-23
MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID (K933579)Telex Communications, Inc.1993-08-23
MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID (K933291)Maico Hearing Instruments, Inc.1993-08-23
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