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

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RecordFirmDate
SEIKO EYEGLASS FRAME (K942513)Seiko Optical Products of America, Inc.1994-07-15
NON-PRESCRIPTION SUNGLASSES (K942783)Sunpoint Import Co., Inc.1994-07-15
IMMOBILE STERILE AND IMMOBILE A/C STERILE (K941940)Tnt Moborg Intl. , Ltd.1994-07-14
BIOMEK SL WITH BIOMEK SL INCUBATOR (K941498)Beckman Analytical and Biotechnology Development1994-07-14
IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (K941850)Tnt Moborg Intl. , Ltd.1994-07-14
STANBIO Y-GT (LIQUICOLOR) TEST SET (K941315)Stanbio Laboratory1994-07-14
SR1 DHEA-S ENZYME IMMUNOASSAY (K942051)Serono Diagnostics, Inc.1994-07-13
EMC FLEXIBLE BIOPSY FORCEPS (K941816)Enterprise Medical Corp.1994-07-13
AIRFRAME SURGICAL DRAPE SUPPORT (K942699)Alpha Surgical, Inc.1994-07-13
CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS (K936166)Medical Analysis Systems, Inc.1994-07-13
ADJUSTABLE BITE CORRECTOR (K942492)Orthoplus, Inc.1994-07-13
DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E (K942043)Alm Surgical Equipment, Inc.1994-07-13
METASYS AMALGAM SEPARATOR MST1 (K934500)Metasys Dental Products, Inc.1994-07-13
WENZHOU IMPORT AND EXPORT CORP (K940627)Sunny Sunglasses1994-07-12
SCHOOL MASCOT EYEWEAR (K942652)School Mascot Eyewear, Inc.1994-07-12
NON-PRESCRIPTION SUNGLASSES (K941441)Sun-Set Enterprise Co. , Ltd.1994-07-12
SUNGLASSES TOKYO BAY (K942500)Tokyo Bay, Inc.1994-07-12
EYECOTECH CORP (K941414)Eyecotech Corp.1994-07-12
A-DEC RADIUS 2122/2132 (K940893)A-Dec, Inc.1994-07-12
JIHN MEI OPTICAL CO. (K940628)Sunny Sunglasses1994-07-12
CHEN-HERSIN SUNGLASSES (K940488)Chen Hersin Ent.1994-07-12
NON-PRESCRIPTION SUNGLASSES (K925596)European & Foreign Imports, Inc.1994-07-12
SUNGLASSES (K940924)Sunny Sunglasses1994-07-12
AUTO REFF-30 (K940516)Canon, Inc.1994-07-12
CLEVER OPTICAL INDUSTRIES LTD (K940626)Sunny Sunglasses1994-07-12
NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES (K941053)Hsin Chen Intl. Co., Ltd.1994-07-12
GIP/MEDI-GLOBE BIOPSY FORCEPS (K941359)Medi-Globe Corp.1994-07-12
YEOU NAN SUNGLASSES CO (K940629)Sunny Sunglasses1994-07-12
BONE GRAFT DELIVERY SYRINGES (K941431)Bio-Interfaces, Inc.1994-07-12
SUNGLASSES (K941538)Solar Sunglasses Corp.1994-07-12
NON-PRESCRIPTION SUNGLASSES (K942588)Pro Axess1994-07-12
CHEN SHUENG ENTERPRISE CO. (K940625)Sunny Sunglasses1994-07-12
SUNGLASSES/VARIOUS COLLECTIONS (K941555)Atlantic Optical Co., Inc.1994-07-12
PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC. (K942348)Oliver Peoples, Inc.1994-07-12
PATIENT EXAMINATION GLOVE (K942086)Qrp, Inc.1994-07-12
WESTERN TRADING CO (K941047)Eva Optiks, Inc.1994-07-12
FRAME, SPECTACLE (K942463)Erica Optical Co.1994-07-12
HOOKING SYSTEM (K930613)Alain Machtelinckx1994-07-12
HYDROSKIN WOUND DRESSING (K942815)Hymedix Intl., Inc.1994-07-11
DISPOSABLE STETHOSCOPE HEAD COVER (K935146)Modern Medical Devices, Inc.1994-07-11
EXTERNAL NASAL SPLINT (K942724)Micromed Development Corp.1994-07-08
CONSERVA POST SYSTEM (K942521)Bull Frog Mfg. Co.1994-07-08
FACE-IT SHIELD (K942022)Onyx Medical Corp.1994-07-08
HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE (K942758)Aladan Corp.1994-07-08
NAVARRE PERCUTANEOUS ACCESS SET (K942315)Navarre Biomedical , Ltd.1994-07-08
GUARDIAN GLOVE (K942313)Guardian Group, Inc.1994-07-08
SUNGLASSES (K941910)The Orvis Co., Inc.1994-07-08
NON-FOGGING DENTAL MIRROR (K941954)Buffalo Dental Mfg. Co., Inc.1994-07-08
ORBSCAN(TM) KERATOMETER (K940647)Orbtek, Inc.1994-07-06
DSL IGFBP-3 RIA (DSL 6700) (K930047)Diagnostic Systems Laboratories, Inc.1994-07-06
CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE (K942736)Carbomedics, Inc.1994-07-06
SUNGLASSES (K941785)K. L. Wings Co., Ltd.1994-07-06
DOA LIQUID DRUGS OF ABUSE CONTROLS (K934498)Medical Analysis Systems, Inc.1994-07-06
STERI-LUBE (K942672)Petroleum Products of America1994-07-06
INFLUENZA A ANTIGEN TEST (K942172)Neogenex1994-07-06
AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE (K941603)Allergan Medical Optics1994-07-06
STREP B OIA (K936112)Biostar, Inc.1994-07-06
AMD DENTIST AND HYGIENIST KITS (K925115)Advance Medical Designs, Inc.1994-07-05
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID (K942594)Starkey Laboratories, Inc.1994-07-05
DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES (K941770)Baxter Healthcare Corp1994-07-05
MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM (K942233)Carl Zeiss, Inc.1994-07-01
BIVONA NASAL TURBINATE STENT (K935053)Bivona Medical Technologies1994-07-01
DOUBLE TRACH SWIVEL CONNECTOR (K940793)Seven Harvest Intl. Import & Export1994-07-01
DISPENS-O-DISC(TM) NITROCEFIN (K941016)Difco Laboratories, Inc.1994-06-30
VINYL EXAMINATION GLOVES (K932054)Assured Medical Supply Co., Ltd.1994-06-30
INFLUENZA B ANITGEN TEST (K942174)Neogenex1994-06-30
SUNGLASSES (K942039)Valiente Co., Ltd.1994-06-30
SUNGLASSES (K940592)Sunblue Intl., Inc.1994-06-30
RSV ANTIGEN TEST (K942173)Neogenex1994-06-30
ENDOTRACHEAL TUBE HOLDER (K942395)S.T.I. Medical Products Corp.1994-06-30
SURGICAL ADHESIVE TAPE (K941943)Raleigh Lions Clinic For the Blind, Inc.1994-06-30
HYPERTONIC SALINE WET DRESSING - STERILE (K941999)Trinity Laboratories, Inc.1994-06-29
INTRASITE (K942748)Smith & Nephew United, Inc.1994-06-29
SUPER-SIL (K940164)Finetone Hearing Instruments1994-06-29
EYE TRAY (K940239)Cush Medical Products1994-06-28
RE-SHARPENABLE SAW BLADES (K940501)Adven Medical1994-06-28
MEDICAL IMAGING WORKSTATION II (MIW II) (K941203)Cemco, Inc.1994-06-27
THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (K925225)Baltimore Therapeutic Equipment Co.1994-06-27
PACSPRO II (K941086)Advanced Video Products, Inc.1994-06-27
CURASALT HYPERTONIC SALINE DRESSING (K942459)Kendall Healthcare Products Co. Div.Of Tyco Health1994-06-27
FLUOROFILM(R) (K933800)American Custom Medical, Inc.1994-06-24
HEARING TECH (K941587)Hearing Tech, Inc.1994-06-24
DERMAL GLOVES (K932953)George Glove Company, Inc.1994-06-24
EUROSTAR SUPER, EUROSTAR VFC (K942036)Starkey Laboratories, Inc.1994-06-24
REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE (K942244)National Custom Ent., Inc.1994-06-24
VINYL EXAMINATION GLOVES (NON STERILE) (K934536)Arista Latindo Industrial Ltd. P.T1994-06-23
M.A.G. INC. ADULT GAS SAMPLING CIRCUITS (K942128)Mag, Inc.1994-06-22
M.A.G. INC. VENTILATOR HOSES (K942123)Mag, Inc.1994-06-22
M.A.G. INC. COAXIAL CIRCUITS (K942135)Mag, Inc.1994-06-22
M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K942136)Mag, Inc.1994-06-22
M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT (K942126)Mag, Inc.1994-06-22
JACE MODEL H440 HAND CPM DEVICE (K931016)Jace Systems, Inc.1994-06-22
M.A.G. INC. HYPERINFLATION SYSTEM (K942132)Mag, Inc.1994-06-22
ANKLE CALF EXERCISER (K942618)Prevent Products, Inc.1994-06-22
COMFIT PINK POWDERED EXAMINATION GLOVES (K936267)Wembley Rubber Products (M) Sdn Bhd1994-06-22
M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K942129)Mag, Inc.1994-06-22
PEDIATRIC ANESTHESIA CIRCUITS (K942122)Mag, Inc.1994-06-22
ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. (K933059)Jace Systems, Inc.1994-06-22
M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS (K942133)Mag, Inc.1994-06-22
COMFIT GREEN POWDERED EXAMINATION GLOVES (K936265)Wembley Rubber Products (M) Sdn Bhd1994-06-22
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