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

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RecordFirmDate
BELTONE COMPARAFIT (K946340)Beltone Electronics Corp.1995-04-13
ULTRACELL RETRACTOR COVERS (K950659)Ultracell Medical Technologies, Inc.1995-04-13
IMEDGE VIDEO OSTOSCOPE (ANALOG) (K951255)Introspect, Inc.1995-04-13
SCIPOTEX (K951171)Wembley Rubber Products (M) Sdn Bhd1995-04-13
MULTI-DRUG CONTROL SET (K951135)Microgenics Corp.1995-04-13
COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) (K936266)Wembley Rubber Products (M) Sdn Bhd1995-04-13
IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE (K950983)Introspect, Inc.1995-04-12
HYPERPACS PACS AND TELERAFIOLOGY SYSTEM (K950343)Rogan Imaging Corp.1995-04-12
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (K950570)Baxter Diagnostics, Inc.1995-04-11
TIELLE* HYDROPOLYMER DRESSING (K946245)Johnson & Johnson International1995-04-11
VIVAPORE 10 (K943965)Vivascience, Inc.1995-04-11
DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET (K950469)Casco Standards1995-04-11
OTI MODEL TLS-60 (K951437)Oti Medical, LLC1995-04-11
VIVAPORE 2 (K943966)Vivascience, Inc.1995-04-11
CARDON PHYSICAL THERAPY TABLES MODELS: R27622 (K950873)Cardon Rehabilitation Products, Inc.1995-04-10
CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER (K944763)Wells Lamont Corp.1995-04-10
RUNNING SUNGLASSES (K945808)Million HU Corp.1995-04-10
THE HEART PROTECTOR (K944481)Garan Scientific, Inc.1995-04-10
SUN-BURST (K951120)Kid'S Wheel-Chairs1995-04-10
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (K951004)Kenex , Ltd.1995-04-10
FI-10P (K951195)Pentax Precision Instrument Corp.1995-04-06
WELCH ALLYN OTOSCOPE (K950787)Welch Allyn, Inc.1995-04-06
FI-10M (K951194)Pentax Precision Instrument Corp.1995-04-06
PYLORISET DRY (K942974)Orion Diagnostica, Div. Orion Corp.1995-04-05
IRISPEC URINE CHEMISTRY CONTROL PART A AND B (K945913)International Remote Imaging Systems1995-04-05
AVL OMNI ANALYZER (K945915)Avl Scientific Corp.1995-04-05
AVON MASSAGING HAIRBRUSH (K950931)Siegel,Mandell & Davidson,P.C.1995-04-05
DV TEST AND DVV CONFIRM (K940490)American Diagnostica, Inc.1995-04-05
OCTEIA IGF-1 KIT (K950510)Immunodiagnostic Systems , Ltd.1995-04-05
CONSENSUS(TM) PATELLA REAMER (K946197)U.S. Medical Products, Inc.1995-04-05
ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) (K950904)Orthofab, Inc.1995-04-05
ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR) (K950903)Orthofab, Inc.1995-04-05
CHEMILUMINESCENCE LH (K935319)Nichols Institute Diagnostics1995-04-05
PINWORM EGG COLLECTOR (K950096)Evergreen Industries, Inc.1995-04-05
GALAXY MD SERIES THERAPYPOOLS (K945824)Galaxy Aquatics, Inc.1995-04-05
POLYDERM (K950033)Wilshire Technologies1995-04-04
BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER (K942250)Biowhittaker Molecular Applications, Inc.1995-04-04
SUNGLASSES (K951209)Mainland Wholesale1995-04-04
RAINS FRONTAL SINUS STENT (K951066)Smith & Nephew Richards, Inc.1995-04-04
WHITSOFT (K942361)Biowhittaker Molecular Applications, Inc.1995-04-04
CURASORB ZN ALGINATE WOUND DRESSING (K950775)Kendall Healthcare Products Co. Div.Of Tyco Health1995-04-03
AURAFLEX(R) ESTRADIOL (K946199)Organon Teknika Corp.1995-04-03
SKYTRON SKYBOOM SERIES (K950192)Skytron, Div. the Kmw Group, Inc.1995-04-03
POLYDOROS SX 65 AND 80 (K950883)Siemens Medical Solutions USA, Inc.1995-04-03
IMMULITE(R) TBG (K950072)Diagnostic Products Corp.1995-04-03
GRX FOAM DRESSING (K945224)Geritrex Corp.1995-04-03
KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (K951003)Kenex , Ltd.1995-04-03
BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE (K942245)Biowhittaker Molecular Applications, Inc.1995-04-03
CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE (K950254)Cypress Medical Products, Ltd.1995-03-31
SILVER ULTRA MINI CANAL (K950458)Electone, Inc.1995-03-31
MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID (K950691)Miracle-Ear, Inc.1995-03-31
MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID (K950692)Miracle-Ear, Inc.1995-03-31
COMPACT-X (K950694)Electromed Intl., Ltd.1995-03-31
MICRO RSH HIGH SPEED HANDPIECE (K935676)Micro Motors, Inc.1995-03-31
UNITRON MODEL ESTEEM (K950759)Unitron Industries, Inc.1995-03-31
ORAL PROCEDURE PACK (K950743)Transidyne General Corp.1995-03-31
NTBS-1417, 1436, TBS-1417 (K946260)Scott Imaging Intl., Inc.1995-03-31
TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES (K944873)Baxter Healthcare Corp1995-03-31
MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID (K950693)Miracle-Ear, Inc.1995-03-31
PROPHYLAXIS PACK (K950773)Transidyne General Corp.1995-03-31
C-POST (K945370)Bisco, Inc.1995-03-31
REP CHOLESTEROL PROFILE CONTROL (K950590)Helena Laboratories1995-03-30
ALKO TONOMETERED SALINE CONTROL (K950902)Alko Diagnostic Corp.1995-03-30
ACCUSCREEN 17-HYDROXYPROGESTERONE (K934178)Neometrics, Inc.1995-03-30
HAND MASSAGE UNIT (K950400)Ultrassage, Inc.1995-03-30
CARDIO REP LD CONTROL - CAT NO. 3325 (K950801)Helena Laboratories1995-03-30
CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER (K946387)Capintec, Inc.1995-03-30
STREAK RETINOSCOPE RX-3 (K950791)Neitz Instruments Company, Ltd.1995-03-28
STREAK RETINOSCOPE RX-RP (K950795)Neitz Instruments Company, Ltd.1995-03-28
SPECTACLE FRAME (K944313)Sun Hing Optical Manufactory , Ltd.1995-03-28
MULTIPLE (K950083)Commonwealth Optical Manufactory , Ltd.1995-03-28
SPOT RETINOSCOPE RX-3SP (K950793)Neitz Instruments Company, Ltd.1995-03-28
STREAK RETINOSCOPE RX-RC (K950794)Neitz Instruments Company, Ltd.1995-03-28
STREAK RETINOSCOPE RX-3A (K950792)Neitz Instruments Company, Ltd.1995-03-28
OLYMPUS INORGANIC PHOSPHORUS REAGENT (K944768)Olympus America, Inc.1995-03-24
THEMALATOR. MODELS T-4-S, T-8-S, ETC. (K950350)Whitehall/Div Columbus Mckennon Corp.1995-03-24
WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER (K950701)Wahl Clipper Corp.1995-03-24
KAB SYSTEM (K951093)King Systems Corp.1995-03-24
HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT (K946078)Clariant Corporation1995-03-24
GOLD CD ULTRA MINI CANAL (K950460)Electone, Inc.1995-03-24
CURAGEL HYDROGEL WOUND DRESSING (K950412)Kendall Healthcare Products Co. Div.Of Tyco Health1995-03-24
GOLD K AMP ULTRA MINI CANAL (K950459)Electone, Inc.1995-03-24
INFANT FLOW SYSTEM (K945740)Hamilton Medical, Inc.1995-03-23
R&D BATTERIES, INC. PART NO. 5128, 5053, 5007 (K944348)R & D Batteries, Inc.1995-03-23
R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 (K944389)R & D Batteries, Inc.1995-03-23
OCIDE HOSPITAL CLEANER-DISINFECTANT (K945227)Clariant Corporation1995-03-23
THE STERN ROOT ANCHOR SYSTEM (K950213)Sterngold/Implamed1995-03-23
BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL (K944728)Bioresource Technology, Inc.1995-03-23
PATIENT EXAMINATION GLOVES (K945885)Hartalega Sdn Bhd1995-03-23
DIGITAL 625HF (K950291)Fischer Imaging Corp.1995-03-23
R&D PART NOS. 5490, 5541, 5358, 5497 (K945870)R & D Batteries, Inc.1995-03-23
R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 (K944388)R & D Batteries, Inc.1995-03-23
PROSYS URIHESICE SYSTEM NL (K950690)Convatec, A Division of E.R. Squibb & Sons1995-03-23
T-GUARD (K945537)Med ET AL Development1995-03-23
IMMULITE C-PEPTIDE (K943767)Diagnostic Products Corp.1995-03-23
TRACHE-TITE (K950930)The Varner Group, Inc.1995-03-22
COLDCIDE-2 (K950553)Metrex Research Corp.1995-03-22
CUSTOM OCULAR PROSTHESIS (K946226)Frank Tanaka, Ocularist, Inc.1995-03-22
COLDCIDE-10 (K950516)Metrex Research Corp.1995-03-22
LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK (K940383)National Laboratories1995-03-22
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