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

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RecordFirmDate
ORVIS POLARIZED BI-FOCALS (K943131)The Orvis Co., Inc.1994-08-02
OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX (K943236)Optiline Imports and Trade, Inc.1994-08-02
STREP-SURE A/E (K941111)Clinical Standards Laboratories, Inc.1994-08-02
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (K941433)Hichem Diagnostics1994-08-02
ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS (K942951)The Orvis Co., Inc.1994-08-02
SPECTACLE FRAMES (K943442)Sunny Union Industrial Co., Ltd.1994-08-02
SUNGLASSES (K943443)Sunny Union Industrial Co., Ltd.1994-08-02
DENTIST WITH ASSISTANT PACK (K940864)Sterile Concepts, Inc.1994-08-02
SPECTACLE FRAME (K943083)Pimex Co., Ltd.1994-08-02
SURGICAL LIFT SHEET (K942807)Surgin Surgical Instrumentation, Inc.1994-08-02
SPECTACLE FRAME (K943086)Radiant Spectacles Manufacturers1994-08-02
SUNGLASSES (K941540)Tonview International Co., Ltd.1994-08-02
SUNGLASSES (K941929)Top Champ, Inc.1994-08-02
ROYAL SHIELD POWDER-FREE LATEX EXAMANATION GLOVES (K942940)Shield Gloves Manufacturer (M) Sdn Bhd1994-08-01
TRI HAWK BUR, FG BUR (K943273)Tri Hawk Corp.1994-08-01
MAYTEX LATEX EXAMINATION GLOVES, POWDERED (K935314)Maytex Corp.1994-08-01
PROBE TIP/PERI PROBE/PERI PROBE COMP. (K936221)Pd International AB1994-08-01
BVR CONTRA-ANGLE HANDPIECE (K934571)Bvr Aero Precision Corp.1994-08-01
POWDER-FREE LATEX EXAMINATION GLOVES (K943151)Shield Gloves Medical Products Sdn Bhd1994-08-01
MAYTEX POWDER-FREE LATEX EXAMINATION GLOVES (K935315)Maytex Corp.1994-08-01
KYOKKO BLUE SERIES INTENSIFYING SCREENS (K942805)Fujifilm Medical System U.S.A., Inc.1994-07-29
MODEL VPW2877F8, MAMMO 5 POWER SUPPLY (K942778)Varian Assoc., Inc.1994-07-29
CTS SYSTEM (K941004)Acoma Medical Imaging, Inc.1994-07-29
COVERLET ADHESIVE DRESSING (K940378)Beiersdorf, Inc.1994-07-29
NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE (K940423)Advanced Technology Laboratories, Inc.1994-07-29
SKIN STAPLE REMOVAL TRAYS (K943046)Sterile Concepts, Inc.1994-07-29
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (K942158)Wfr/Aquaplast Corp.1994-07-29
F/C/W TUBESTAND (K941017)Acoma Medical Imaging, Inc.1994-07-29
KODAK INSIGHT TWIN-LOAD INSERT (K942909)Eastman Kodak Company1994-07-29
COMFEEL PLUS TRANSPARENT DRESSING (K942283)Richard Hamer Assoc., Inc.1994-07-29
SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (K930773)Symbiosis Corp.1994-07-28
WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 (K941876)More Diagnostics1994-07-28
ALGINATE FIBER (K941176)Adri/Technam1994-07-28
SOUTHLAND STERILE DENTAL SYSTEM (K935127)Southland, Ltd.1994-07-28
SERUM VOLATILES CONTROL - LEVELS 1 AND 2 (K941698)More Diagnostics1994-07-28
STAPHYTECT-OD (K940557)Unipath , Ltd.1994-07-28
EASSUN HI-TECH OPTICS (K943202)Ultimate Concepts, Inc.1994-07-27
OPTICAL FRAMES AND SUNGLASSES (K926564)Solstar Produktions GmbH1994-07-27
B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG (K942645)B & F Medical Products, Inc.1994-07-27
DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER (K925243)Deknatel, Inc.1994-07-27
MS-30 AUTOMATIC PERIMETER (K943234)Marco Ophthalmic, Inc.1994-07-27
GLADIATOR (K942932)Gladiator Sports1994-07-27
BODY FLEX (K942950)Conair Corp.1994-07-26
SPONGE, LAPAROTOMY, VARIOUS SIZE (K940436)Shawnee Products, Inc.1994-07-26
DENTAL TRAY (K941349)Cush Medical Products1994-07-26
SPECTACLE FRAME (K943084)Samil Enterprise Co.1994-07-25
SUNGLASSES (K942038)Golden Year Supply Co.1994-07-25
SAM SUNG OPTICAL (K942067)Sam Sung Optical1994-07-25
LYSOL I.C. BRAND QUATERNARY CLEANER DISINFECTANT (K940381)National Laboratories1994-07-25
HAPPY EYES OPTICAL CO. SUNGLASSES (K941581)Happy Eye Optical Co.1994-07-25
MARS SUNGLASSES (K932484)Mars Promotional Services, Inc.1994-07-25
LYSOL I.C. BRAND DISINFECTANT SPRAY (K940400)L&F Products1994-07-25
MIRACLE-EAR EAR IMPRESSION MATERIAL (K941859)Miracle-Ear/Dahlberg, Inc.1994-07-25
SUNGLASSES (K940925)Gold Link Design , Ltd.1994-07-25
R&D BATTERIES, PART NO. 5025, 5128 AND 5183 (K942018)R & D Batteries, Inc.1994-07-25
SUNGLASSES (K942001)Hung Wai Optical Co.1994-07-25
OPTICOM M600 (K932258)Clement Clarke, Inc.1994-07-25
LIFE PULSE RESUSCITATION TIMER (K932867)Green Field Medical Sourcing, Inc.1994-07-25
SUNGLASSES (K941874)The Fair Optical Ent.Co. , Ltd.1994-07-25
SUNGLASSES, SPECTACLE FRAMES (K940372)Giorgio Nannini Srl1994-07-25
SPECTACLE FRAMES (K942750)Aspex Eyewear, Inc.1994-07-25
NIL (K942755)Ever Great International , Ltd.1994-07-25
AUTO SUTURE PITUITARY SPINAL RONGEUR (K943115)United States Surgical, A Division of Tyco Healthc1994-07-25
NON-PRESCRIPTION SUNGLASSES (K942673)Angel Eyewear1994-07-25
ORVIS WORLD FINEST POLARIZED CLIP ONS (K942952)The Orvis Co., Inc.1994-07-25
SUNGLASSES (K942037)Golden Year Supply Co.1994-07-25
TEMPOARY POLYCARBONATE CROWNS (K932759)South American Dental Exporting Corp.1994-07-22
O-TRAY IMPRESSION TRAYS (K942668)Dentauraum, Inc.1994-07-22
HAE 1 (K942829)Hearing Aid Express1994-07-20
AUTO SUTURE SPINAL DISSECTOR (K942971)United States Surgical, A Division of Tyco Healthc1994-07-20
KIT PAK DRESSING CHANGE TRAY (K941499)Kit Pak, Inc.1994-07-20
HAE 3 (K942830)Hearing Aid Express1994-07-20
AURIS CIC (K943144)General Hearing Instruments, Inc.1994-07-20
AUTO SUTURE SPINAL CURETTE (K942967)United States Surgical, A Division of Tyco Healthc1994-07-20
DNA TRIGLYCERIDE PROCEDURE (K941063)Data Medical Associates, Inc.1994-07-20
AUTO SUTURE SPINAL ELEVATOR (K942970)United States Surgical, A Division of Tyco Healthc1994-07-20
ACS CARDIO-TROL CONTROL (K941115)Analytical Control Systems, Inc.1994-07-20
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (K935984)Sigma Diagnostics, Inc.1994-07-20
COSMET (K933465)Great Bay Medical Products, Inc.1994-07-20
DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4 (K940433)Medical Analysis Systems, Inc.1994-07-20
AUTO SUTURE SPINAL OSTEOTOME (K942968)United States Surgical, A Division of Tyco Healthc1994-07-20
TECNADYNE T-CUFF (K942303)Technadyne Scientific, Inc.1994-07-20
HAE 2 (K942831)Hearing Aid Express1994-07-20
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (K941662)Gm Engineering, Inc.1994-07-20
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE (K941221)Dupont Medical Products1994-07-20
STANBIO ALT/GPT (LUQUI-UV) TEST SET (K941314)Stanbio Laboratory1994-07-20
AUTO SUTURE SPINAL NERVE HOOK (K942969)United States Surgical, A Division of Tyco Healthc1994-07-20
CLAMPS AND CLIPS (K942896)Surgin Surgical Instrumentation, Inc.1994-07-19
MICRON-SCOPE II (K926412)Chiron Vision Corp.1994-07-19
SPLASH MASK (K941932)Incon Diversified Industries, Inc.1994-07-19
SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM (K942526)Life Medical Sciences, Inc.1994-07-19
MED-EVAC-4 MEDICAL EVACUATION STRETCHER (K942356)Montery Bay Corp.1994-07-19
MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 (K932482)Medix Biotech, Inc.1994-07-18
QUICKVUE IN-LINE ONE-STEP STREP A TEST (K934484)Quidel Corp.1994-07-18
HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT (K942749)Madsen Electronics (Canada) , Ltd.1994-07-18
ABBOTT PRISM ANALYZER (K940289)Abbott Mfg., Inc.1994-07-18
TEC 2101 (MODEL MT-HPLGD) (K941169)Medtec, Inc.1994-07-18
CHLAMYDIA TRACHOMATIS ANTIGEN TEST (K941714)Neogenex1994-07-18
U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES (K942119)U-Top Enterprise Co., Ltd.1994-07-15
NON-PRESCRIPTION SUNGLASSES (K936072)King'S Sunglass Corp.1994-07-15
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