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

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RecordFirmDate
MRX MICROPLATE READER (K943701)Dynatech Laboratories, Inc.1994-10-20
FEDELITY F495, VIENNATONE ALPP II (K943687)Starkey Laboratories, Inc.1994-10-20
SEALITE SCIENCE, INC. AQUALITE(R) LH (K943188)Sealite Sciences, Inc.1994-10-20
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS (K943960)Miracle-Ear, Inc.1994-10-20
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (K943996)Dupont Medical Products1994-10-20
WIDEX MODEL LX-ITE (K944838)Widex Hearing Aid Co., Inc.1994-10-20
MULTIPLE ED1600 SERIES RADIATION SHIELDS (K944772)Image Diagnostics, Inc.1994-10-20
COHORT AVB RETRACTOR SYSTEM (K943472)Cohort Medical Products Group, Inc.1994-10-20
BELTONE CONCERTO S (K944502)Beltone Electronics Corp.1994-10-20
ALSA-KLENZ (K944494)Calgon Vestal Div.1994-10-19
LATEX EXAM GLOVES (K941787)P.T. Irama Dinamika Latex1994-10-19
SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE (K944738)Ducker CL1994-10-19
VINYL EXAMINATION GLOVE, POWDER-FREE (K944510)American Gemini, Inc.1994-10-18
NASCOR IGLOO (K935126)Nascor Pty. , Ltd.1994-10-18
LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) (K944574)Lumex, Inc.1994-10-17
HEAT AND MOISTURE EXCHANGER FILTER (HME) (K943915)Medicomp, Inc.1994-10-14
MUMPS STAT (K925209)Biowhittaker Molecular Applications, Inc.1994-10-14
CHIN UP (K943837)Edward Carden1994-10-14
CARBON LIGHTS HAND SURGERY TABLE (K944779)Allen Medical Systems, Inc.1994-10-14
SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR (K942731)Shimadzu Corp.1994-10-13
POWDERED DISPOSABLE LATEX EXAM GLOVES/ANNEXURES (K942149)Ti-Mate Prophylactic Devices , Ltd.1994-10-13
LSVP INTERNATIONAL BIOPSY FORCEPS (K944770)Lsvp Intl., Inc.1994-10-13
COMFIT (STERILE) (K944141)Wembley Rubber Products (M) Sdn Bhd1994-10-13
PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM (K944077)Argosy Electronics1994-10-12
EURO TECH DIAMOND CHIROPRACTIC TABLE (K943972)Progressive Electrical Therapeutics1994-10-11
OXYGEN MOUTHGUARD (K944049)Endovations, Inc.1994-10-11
COHORT BONE BRUSH (K942108)Advanced Med/Surg, Inc.1994-10-11
VIDEO OTOSCOPE (K943731)Cuda Products Co.1994-10-11
ISOLATED CAMERA HEAD (K944707)Envision Medical Corp.1994-10-07
VIROTROL TORCH (K942295)Blackhawk Biosystems, Inc.1994-10-07
ENSURE POWDER-FREE LATEX PATIENT EXAMINATION GLOVES (K942643)Basic Intl., Inc.1994-10-07
URINARY CATECHOLAMINE KIT (K943099)Bioanalytical Systems, Inc.1994-10-07
EXAMINATION GLOVES (K942877)Masif Healthcare Products Sdn. Bhd.1994-10-07
BILL EVANS-KLENZ (K944033)Calgon Vestal Div.1994-10-07
MAUNAL DISPOSABLE DENTAL INSTRUMENTS (K943351)Magnum Instruments, Inc.1994-10-07
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED (K942551)Medi-Tech, Inc.1994-10-06
HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (K943334)Jay H. Geller1994-10-05
BREAST SHELL (K944177)O'Donnell, Byrne & Williams1994-10-05
MOUTH PROPS (K940785)Worldwide Dental, Inc.1994-10-05
AVENT NIPPLE SHIELD (K944117)Avent America, Inc.1994-10-05
HITACHI 914 ANALYZER (K942364)Boehringer Mannheim Corp.1994-10-04
ACRYDERM ADVANCED WOUND DRESSING (K943781)Acrymed, Inc.1994-10-04
THE WUSCOPE SYSTEM (K941319)Achi Corp.1994-10-04
KARL STORZ LARYNGOSCOPE ACCESSORIES (K944295)KARL STORZ Endoscopy-America, Inc.1994-10-04
KOVA LIQUA-TROL (K942853)Hycor Biomedical, Inc.1994-10-04
HICHEM ENZYME VERIFIER KIT (K943684)Hi Chem, Inc.1994-10-04
MULTI ANALYTE LINEARITY SET (K936245)Teco Diagnostics1994-10-04
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING (K943925)Quantimetrix Corp.1994-10-04
LIFE PULSE TESUSCITATION TIMER (K944667)Green Field Medical Sourcing, Inc.1994-10-04
DISPOSABLE, PREFORMED FACE MASK (K944157)Meridian Medical Systems, Inc.1994-10-03
SUNGLASSES (K944281)Sun Glory Optic CO , Ltd.1994-10-03
SUNGLASSES (K942011)Shanghai Gopher Arts & Crafts Co., Ltd.1994-10-03
TONKA BOYS SUNGLASSES (K944328)Hasbro Industries, Inc.1994-10-03
BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (K941788)Johnson & Johnson Consumer Products, Inc.1994-10-03
CURADERM ALGINATE HYDROCOLLOID (K943636)Kendall Healthcare Products Co. Div.Of Tyco Health1994-10-03
BAND-AID(TM) BRAND ADHESIVE BANDAGE (K940536)Johnson & Johnson Consumer Products, Inc.1994-10-03
HYDROTRACK (K935509)Ferno Ille1994-10-03
DIGITAL I.D. CAMERA (K942883)Miles Inc., Agfa Division1994-09-30
ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (K925405)Synectics-Dantec1994-09-30
AQUAPLAST TIE DOWN DRESSING (K943871)Wfr/Aquaplast Corp.1994-09-30
FAMILY FITNESS SHIATSU MASSAGER (K943092)Conair Corp.1994-09-29
ROYAL SHIELD PINK COLORED NON-STERILE LATEX EXAMINATION GLOVE (K943807)Shield Gloves Manufacturer (M) Sdn Bhd1994-09-29
EURO TECH MARQUISE CHIROPRACTIC TABLE (K943974)Progressive Electrical Therapeutics1994-09-29
STATLOCK CV (K943147)Venetec, Inc.1994-09-29
AL-3300 (K940997)Hoya Corp. USA1994-09-29
PODIATRIC MATERIAL (K940132)Crown Delta Corp.1994-09-29
EURO TECH PLATINUM CHIROPRACTIC TABLE (K943975)Progressive Electrical Therapeutics1994-09-29
SPECTACLE FRAMES (K944373)Custom Optical Frames, Inc.1994-09-28
SILHOUETTE, SUNLIMETED,ADIDAS (K944160)Silhouette Optical , Ltd.1994-09-28
WIRELESS CHART PROJECTOR,HCP-W 721 (K936200)Canon USA, Inc.1994-09-28
SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (K931963)Sandhill Scientific, Inc.1994-09-28
SHIPPERT PRESSURE BANDAGE (K940798)Denver Splint Co.1994-09-28
SUNGLASSES (K941006)Opti-Ray, Inc.1994-09-28
AUTOMATIC LENSOMETER (K936199)Canon USA, Inc.1994-09-28
COMPREHENSIVE PHOROPTER, MDR-680 (K936205)Canon USA, Inc.1994-09-28
BOUFFANT CAP (K940228)Derekduck Industries Corp.1994-09-26
ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUM (K943043)Shield Gloves Manufacturer (M) Sdn Bhd1994-09-26
SHOE COVER (K940226)Derekduck Industries Corp.1994-09-26
ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-STRAWBERRY (K943044)Shield Gloves Manufacturer (M) Sdn Bhd1994-09-26
PATIENT EXAMINATION GLOVES (K943434)Pacewell Sdn Bhd1994-09-26
MIRACLE-EAR MIRAGE (K943826)Miracle-Ear, Inc.1994-09-23
SURGICAL INSTRUMENTS AND ACCESSORIES (K942956)Stryker Corp.1994-09-23
MIRACLE-EAR IMPRESSION MATERIAL KIT (K942523)Miracle-Ear, Inc.1994-09-23
VIDEO SCOPE SYSTEM (OTOSCOPE) (K944031)Jedmed Instrument Co.1994-09-23
PM-PAGER (K933552)Hill Engineering1994-09-22
ADVANCED IN-BED WEIGH SYSTEM (K943587)Future Systems, Inc.1994-09-22
PRESTERILIZED ENDODONTIC FILES (K943584)Dentsply Intl.1994-09-21
RESOUND PERSONAL HEARING SYSTEM (K943788)Resound Corp.1994-09-21
ROYAL SHIELD RUBBER DAMS (K942992)Elastomade Accessories Sdn Bhd1994-09-21
NIL (K943613)Sing Wah International Enterprises , Ltd.1994-09-21
KENDALL MODU-VAC CLOSED SUCTION SYSTEM (K944251)Kendall Healthcare Products Co. Div.Of Tyco Health1994-09-21
MIRACLE EAR CONFIDANTE (K943825)Miracle-Ear, Inc.1994-09-21
IMKB CONTRA-ANGLES (K933639)Micro-Mega1994-09-21
XLT, REA COMFORT, SPIREA, ZOOM (K943936)Electric Mobility Corp.1994-09-21
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY (K935393)Bio-Rad Laboratories, Inc.1994-09-20
KT2000 KNEE LIGAMENT ARTHROMETER (K942059)Medmetric Corp.1994-09-20
THE YELLOW IRIS (K943463)Intl. Remote Imaging Systems1994-09-20
PROSPECT MICROPLATE ASSAY (K934493)Alexon, Inc.1994-09-20
IMMUNOCARD MYCOPLASMA (K934550)Meridian Diagnostics, Inc.1994-09-20
EXAMINATION GLOVES, POWDER FREE (K935384)Jf Trading Co., Ltd.1994-09-19
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