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

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RecordFirmDate
IMAGING WORKBENCH (K943383)Brit Systems, Inc.1994-11-22
DERMAGRAN HYDROPHILIC OINTMENT (K944491)Derma Sciences, Inc.1994-11-22
BREAST LESION LOCALIZATION NEEDLE (K945124)Promex, Inc.1994-11-22
ALT QVET (K944080)Prisma Systems1994-11-22
ARISTAR EYEWEAR, ESPRIT EYEWEAR (K945122)Aristar Inc. U.S.A.1994-11-22
RED DRAGON CORPORATION (K945249)J C Intl., Inc.1994-11-22
SPECTACLE FRAMES OR EYEGLASS FRAMES (K945340)Mi Mun Corp.1994-11-22
BRIGHTEN (K945036)New Daley Intl. Trading Co.1994-11-22
SPECTACLE FRAME (K945323)M.Y. Vision Corp.1994-11-22
SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR (K944312)Shelin International Ent., Inc.1994-11-22
AD/V IMAGEPLEX(TM) (K943158)Adaptive Video, Inc.1994-11-22
NON-PRESCRIPTION SUNGLASSES (K944996)La Kinglong Intl., Inc.1994-11-22
KERATRON CORNEAL TOPOGRAPHER (K944616)Alliance Medical Marketinig1994-11-22
FRAME, SPECTACLE (K945450)Kookje Apis Industrial Co.1994-11-22
INSIGHT ELECTRONIC ALIGNMENT INDICATOR (K940812)Andronic Devices, Ltd.1994-11-21
OTOVIEW TELESCOPIC OTOSCOPES (K943721)Smith & Nephew, Inc.1994-11-18
PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING (K944429)Precision Thermoplastic Components, Inc.1994-11-18
CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING (K945314)Cleveland Tubing, Inc.1994-11-18
SAS QUANT HCG URINE (K944891)Sa Scientific, Inc.1994-11-17
ISOSCAN (K944185)Isolab, Inc.1994-11-17
LENSCHEK (K944022)Leica, Inc.1994-11-17
MULTIDEX HYDROPHILIC WOUND DRESSING (K945000)Lange Medical Products, Inc.1994-11-17
SERUM PROTEIN CONTROLS (K944515)Pyramid Biological Corp.1994-11-17
FILTER, DIFFUSER (K940276)Anspach Mfg., Inc.1994-11-16
MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID (K944241)Magnatone Hearing Aid Corp.1994-11-16
DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET (K944338)Casco Standards1994-11-15
LITE-BLADE (K944428)Eare Consulting Service1994-11-15
DMA IRON PROCEDURE (K944462)Data Medical Associates, Inc.1994-11-15
DANAVOX MODEL CIC (K942331)Gn Danavox, Inc.1994-11-15
SUNGLASSES AND SPECTACLE FRAMES (K944644)Hung Wai Metal Manufactory1994-11-15
PROCHEQ 1 & 2 (K944059)Prisma Systems1994-11-15
OPTICAL FRAMES AND SUNGLASSES (K944526)Aprilia Eyewear S.P.A.1994-11-15
COMPASS SOFTWARE MODULE (K944097)Widex Hearing Aid Co., Inc.1994-11-15
ARTHREX GRAFT HARVESTING KIT (K941285)Arthrex, Inc.1994-11-14
REXPLUS PP3 (K944548)Rexton, Inc.1994-11-14
ULTRAPRO WORKSTATION (K942917)Ramsoft, Inc.1994-11-14
MONOJECT BONE MARROW BIOPSY TRAYS (K945109)Sherwood Medical Co.1994-11-14
GENERAL ANESTHESIA SYSTEM (K944949)Vital Signs, Inc.1994-11-14
ROYAL PLASTIC SUNGLASSES (K944341)Royal Plastic Sarl1994-11-14
NIL (K944641)Max-Vision (H.K.)Limited1994-11-14
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED (K944202)Abbott Laboratories1994-11-14
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM (K944093)E.I. Dupont DE Nemours & Co., Inc.1994-11-10
TRI BLOCK POLUMER GEL SHEETING (K942695)Silipos, Inc.1994-11-10
REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT (K935162)Helena Laboratories1994-11-10
DUPONT ACA STAR (K941050)Dupont Medical Products1994-11-10
SUNGLASSES (K945001)Long Sheng Optical Co., Ltd.1994-11-10
KODI OPTICAL CO., LTD. SUNGLASSES (K944484)Kodi Optical Co. , Ltd.1994-11-10
DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) (K943148)Diagnostic Systems Laboratories, Inc.1994-11-10
CORRUGATED TUBING (K940890)Cleveland Tubing, Inc.1994-11-10
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM (K942451)Bio-Rad1994-11-10
CONNECTORS AND AIRWAY EXTENSIONS (K940889)Cleveland Tubing, Inc.1994-11-10
VILLALTA RETRACTOR (K943875)Hct, Inc.1994-11-09
EAST WEST INSTRUMENTS (K941193)East West Instruments, Inc.1994-11-09
CHEMSTRIP MINI UA URINE ANALYZER (K943592)Boehringer Mannheim Corp.1994-11-08
HOME CARE EAR EXAMINATIO KIT (K944897)Home Care Instruments, Inc.1994-11-08
DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (K945440)Fvtnks1994-11-08
DYNASTY U1-31 (GELL/CELL) (K942309)Foley & Lardner1994-11-07
DYNASTY GC 12550 (GELL/CELL) (K942310)Foley & Lardner1994-11-07
THE OSTEOMED B POWER SYSTEM AND ACCESSORIES (K933101)Osteomed Corp.1994-11-07
DYNASTY GC 12400 (GELL/CELL) (K942308)Foley & Lardner1994-11-07
STERILE PLASTIC DRESSING (K944588)Smith & Nephew, Inc.1994-11-07
STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (K941896)Depuy, Inc.1994-11-07
OPTUS LARYNGOSCOPES (K945269)Optus, Inc.1994-11-07
DYNASTY U1-33 AGM (K942311)Foley & Lardner1994-11-07
BREAST LESION LOCALIZATION NEEDLE (K944942)Promedical , Ltd.1994-11-04
FIBEROPTIC LARYNGOSCOPE HANDLE (K944686)Fiberoptic Medical Products, Inc.1994-11-04
NCE REPLACEMENT BATTERIES (K943680)National Custom Ent., Inc.1994-11-04
CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, (K944923)Clinical Controls, Inc.1994-11-04
SMILE INTEGRATED PROPHYLAXIS PASTE RINGS (K942851)Germiphene Corp.1994-11-04
REPLACEMENT BATTERIES (K943632)National Custom Ent., Inc.1994-11-04
PROXIDERM (TENTATIVE) (K942425)Progressive Surgical Products, Inc.1994-11-04
ORAFIX SPECIAL DENTURE ADHESIVE (K943486)Smithkline Beecham Corp.1994-11-03
SYNCHRON CX3 DELTA (K942676)Beckman-Diagnostic Systems Group1994-11-02
TRUZONE PFM DISPOSABLE MOUTHPIECE (K944512)Monaghan Medical Corp.1994-11-02
TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL (K943422)Utak Lab, Inc.1994-11-02
MR7000 WITH TIME MANAGER SOFTWARE (TMS) (K934111)Dynatech Laboratories, Inc.1994-11-02
URINE COLLECTOR & ACCESSORIES (K945204)Nelmed Corp.1994-11-02
ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER (K942753)Researched, Novel Medical Devices (Rn/Md)1994-11-02
INFORMER PLUS (K943481)Micro-Tech Medical, Inc.1994-11-02
ENZYME-LINKED FLUORESCENT IMMUNOASSAY (K943811)Biomerieux Vitek, Inc.1994-11-02
STAT PAK (K943820)Magnum Instruments, Inc.1994-11-02
CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL (K944247)Cala Diagnostics1994-10-31
IMMULITE SHBG (K941797)Diagnostic Products Corp.1994-10-31
ROCHE REAGENT (K941573)Roche Diagnostic Systems, Inc.1994-10-31
CARDIOCHEX CKMB MASS MEASUREMENT CONTROL (K944246)Cala Diagnostics1994-10-31
HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 (K935599)Clinical Controls, Inc.1994-10-31
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) (K943780)Heraeus Kulzer, Inc.1994-10-31
CAMERA COVER WITH TEAR TIP (K940152)Hydro-Med Products, Inc.1994-10-28
P2 NITRILE EXAM GLOVES (K944095)Biosafety Systems, Inc.1994-10-28
P2 EXAM GLOVES (K944142)Biosafety Systems, Inc.1994-10-28
SUNGLASSES (K944394)Unique Industries, Inc.1994-10-27
MONOJECT SAMPLETTE SEPARATOR TUBE (K941291)Sherwood Medical Co.1994-10-27
MICROSPORIDIUM CONTROL SET (K943228)Meridian Diagnostics, Inc.1994-10-27
CARDIOCHEX (K944243)Cala Diagnostics1994-10-27
SUN EYEWEAR COMPANY, MULTIPLE BRAND NAMES (K944783)Sun Eyewear Co.1994-10-27
PRO-STEP LH OVULATION PREDICTION TEST (K943252)Disease Detection International, Inc.1994-10-25
4 CHANNEL DISPENSER (K944556)Tecan U.S., Inc.1994-10-25
MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5) (K941579)Microtest1994-10-21
PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT (K944078)Argosy Electronics1994-10-21
RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES (K926463)Midmark Corp.1994-10-21
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