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

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RecordFirmDate
CARESS SANITARY NAPKIN (K951693)Sterling U.S.A., Inc.1995-07-25
PERIO-MED DENTAL FLOSS (K944034)Whitehill Oral Technologies, Inc.1995-07-25
DELPORE SKIN CLOSURE (K952947)Bitco Intl.1995-07-24
DYNAMIC EQ/CLASS D (K953038)Midwest City Hearing Aid Center1995-07-21
MWCHAC 95 FS 12345 (K952821)Midwest City Hearing Aid Center1995-07-21
MWCHAC 95 C 12345 (K952820)Midwest City Hearing Aid Center1995-07-21
DB PUSH-PULL HEARING AID (K953036)Midwest City Hearing Aid Center1995-07-21
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (K946353)Mrl Diagnostics1995-07-21
AQUAGEL LUBRICATING JELLY (K951431)Depuy Healthcare1995-07-21
NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (K952824)Intertex Medical, Inc.1995-07-20
HUMID-VENT 2 (K952844)Gibeck, Inc.1995-07-20
HUMID-VENT 1 (K952750)Gibeck, Inc.1995-07-20
ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) (K946056)Ampri Rubberware Industries Sdn Bhd1995-07-20
SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE (K952404)Aladan Corp.1995-07-20
VINYL PATIENT EXAMINATION GLOVES (K941809)Cheer & Merit Co., Ltd.1995-07-20
IL TEST LIPASE (K952647)Instrumentation Laboratory CO1995-07-20
LIPASE FLEX REAGENT CARTRIDGE (K952816)Dupont Medical Products1995-07-20
MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES (K953208)Standard Welders Supply Co.1995-07-20
CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT) (K953037)Midwest City Hearing Aid Center1995-07-20
TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES (K952786)Baxter Healthcare Corp1995-07-20
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY (K952127)Boehringer Mannheim Corp.1995-07-20
BOBES LENS SET (K945443)Bobes S.A.1995-07-19
SUNGLASSES (K953260)Eye Deals1995-07-19
DENTAURUM JACKET CROWN & ROOT POSTS (K952868)Dentauraum, Inc.1995-07-19
FOSTER GRANT NON PRESCRIPTION SUNGLASSES (K953092)Foster Grant Group1995-07-19
MAXILUBE (K943010)Mission Pharmacal Co.1995-07-19
FORCEPS, BIOPSY, NON-ELECTRIC (K952863)Annex Medical, Inc.1995-07-19
NYX GOLF VISION SYSTEM (K953245)Nyx Golf, Inc.1995-07-19
DENTAL KIT (K945815)Constancy Ent., Inc.1995-07-19
DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP (K946046)Deroyal Critical Care, Div. Deroyal Technologies1995-07-19
KENLOR LIQUID TOTAL URINE CONTROL (K952840)Kenlor Industries, Inc.1995-07-19
SELECTA 20/60 CHEMISTRY ANALYZER (K942922)Select Medical Systems, Inc.1995-07-19
CONAIR FAMILY FITNESS BODY ENERGY (K950441)Conair Corp.1995-07-18
HM-CAP EIA KIT (K944159)Schiff & Co.1995-07-18
ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (K952082)Rochester Medical Corp.1995-07-18
PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET (K950178)Pharma-Plast Intl. A/S1995-07-17
ACTIVE FREE TESTOSTERONE RIA (K952281)Diagnostic Systems Laboratories, Inc.1995-07-17
SUNGLASSES (K951979)Heyro Optical Manufactory1995-07-17
ULTIMAX (K951473)Wembley Rubber Products (M) Sdn Bhd1995-07-17
FREDEIC BEAUSOCEIL (K951551)Pascal Mathieux1995-07-17
GS & GS20 SURGICAL TOOL SYSTEM (K952463)Midas Rex Pneumatic Tools, Inc.1995-07-17
DADE STRATUS TROPONIN-I CONTROL (K951888)Dade Intl., Inc.1995-07-13
MULTICURE(R) S GEL PAD (K950085)Multigestion (Deutschland) GmbH1995-07-13
FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE (K952823)Icor AB1995-07-13
SILON SILICONE FOAM SHEETING (K946362)Bio Med Sciences, Inc.1995-07-13
METAL FRAM WITH POLYCARBONATE LENS (K953002)Nakanishi Optical Products Corp.1995-07-12
COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI (K942647)Scantibodies Laboratory, Inc.1995-07-12
READY NURSE SYSTEM (RNS) TRACH CARE KIT (K952925)Contour Fabricators of Florida, Inc.1995-07-12
DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS (K953012)Boston Surgical Products, Inc.1995-07-12
SUNGLASSES (K952890)Isohyper1995-07-12
STERIGAUZE WET DRESSING (K952420)Acacia Laboratories, Inc.1995-07-12
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G (K952822)Shimadzu Corp.1995-07-12
CLEAN-CUFF (K952038)Instrumed, Inc.1995-07-11
GOLD CD ULTRA MINI CANAL - MODULE (K951642)Electone, Inc.1995-07-11
BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT (K951538)Syntron Bioresearch, Inc.1995-07-11
PHENO-CEN GERMICIDAL DETERGENT (K951162)Central Solutions, Inc.1995-07-11
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (K952689)Owens-Brigam Medical Co.1995-07-11
WELCH ALLY OTOSCOPE (K952578)Welch Allyn, Inc.1995-07-10
COLD LIGHT SOURCE LOS 150 (K951829)Laser-Optik-Systeme GmbH & Co. KG1995-07-10
STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (K952678)Avail-Southwest Division1995-07-10
OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) (K951806)Opgal Optronic Industries1995-07-06
CLEAR ADVANTAGE II (K945628)Mentor Corp.1995-07-06
OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL (K952452)Argosy Electronics1995-07-06
CLASS D LINEAR WITH ACTIVE TONE CONTROL (K952451)Argosy Electronics1995-07-06
QUICKIE TSR (K952641)Sunrise Medical, Inc.1995-07-06
3M MAXI-DRIVER II ELECTRIC SYSTEM (K951118)3M Company1995-07-06
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR (K952265)Control-X, Inc.1995-07-06
STAT PROFILE ULTRA BLOOD GAS CONTROLS (K952477)Nova Biomedical Corp.1995-07-06
THE HILL ADJUSTABLE PODIATRY MODEL (K952357)Hill Laboratories Co.1995-07-06
WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL (K952450)Argosy Electronics1995-07-06
CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE (K952367)Cypress Medical Products, Ltd.1995-07-05
OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT (K952425)Olympus America, Inc.1995-07-05
LORI-A (K952711)Lori Medical Laboratories, Inc.1995-07-03
AMERLITE FSH ASSAY (K952285)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-03
INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) (K952505)Nichols Institute1995-07-03
ACUTEK'S CLEARPASSAGE (K951644)Acutek Adhesive Specialties, Inc.1995-07-03
SUCTION CATHETER KIT, STERILE, SINGLE-USE (K951506)Trinity Laboratories, Inc.1995-07-03
MEDIPACS (K950413)Nexsys Electronics1995-06-30
HYDRAGEL PROTEIN(E) KIT (K951536)Sebia1995-06-30
ACURA-EX (K946232)Lustgarten Multi-Tech Intl.1995-06-30
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT (K951828)Siemens Hearing Instruments, Inc.1995-06-30
BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K (K951587)Beltone Electronics Corp.1995-06-30
ACUFEX ROTATOR CUFF FIXATION BUTTON (K941740)Acufex Microsurgical, Inc.1995-06-30
FLEX D-4000 (K951419)U.S. Table, Inc.1995-06-30
MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS) (K951175)Sirius Corp.1995-06-30
OMNI-JUG (K952200)Waterstone Medical, Inc.1995-06-29
DERMA SEAL (K952702)Ttl Medical1995-06-28
INTEC FULL FACE SHIELD (K946003)Intec Industries, Inc.1995-06-28
BELTONE COMPOSER 2000 (K950868)Beltone Electronics Corp.1995-06-28
VUTLER G.U.M. WITH FLUORIDE (K952091)John O. Butler Co.1995-06-28
PATIENT EXAMINATION GLOVE (K951940)Lowenkamp Intl., Inc.1995-06-28
HORTMANN AIRMATIC AIR CALORIC STIMULATOR (K950785)Jedmed Instrument Co.1995-06-28
OTOSONIC (OSI) CF 10-K, 10-D (K952097)Beltone Electronics Corp.1995-06-28
ROBERT B. SCOTT PLASTIC ARTIFICAL (K952538)Robert B. Scott Ocularists of Florida, Inc.1995-06-26
SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE (K952556)Aladan Corp.1995-06-26
RENALIN COLD STERILANT (K941439)Minntech Corp.1995-06-26
SUNGLASSES (K951815)Fung Won Optical Mfg. Co.1995-06-26
DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL (K952412)Dupont Medical Products1995-06-23
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A (K952484)Toshiba America Medical Systems, In.C1995-06-23
VINYL POWDER-FREE EXAMINATION GLOVES (K946021)Wilson Glove Products Co., Ltd.1995-06-23
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