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

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RecordFirmDate
STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER (K951141)Star Technologies, Inc.1995-05-30
DIGITAL RETINOSCOPIC PHOTOMETER (K951179)Kudi Kalu, Inc.1995-05-30
SALINE SOLUTINE, STERILE (K950560)Busse Hospital Disposables, Inc.1995-05-30
CONNECTING TUBE (K951745)Vital Signs, Inc.1995-05-30
SKALPI 3200 (K946382)Wiscco Development, Inc.1995-05-30
CUSTOM ARTIFICIAL HUMAN EYES (K945270)Daniel T Acosta1995-05-30
INSTACINE (K942558)Fidelity Medical, Inc.1995-05-30
ADVIEWER 2000 (K952188)Adp , Ltd.1995-05-30
MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS (K951324)Maxol Limited L.C.1995-05-26
SPECTACLE SUN GLASSES (K940324)Occhiali, International Eyewear1995-05-26
GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (K950311)Global Medical Products, Ltd.1995-05-26
MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) (K952300)Midas Rex Pneumatic Tools, Inc.1995-05-26
CARDON PHYSICAL THERAPY TABLE MODEL: R27841 (K950872)Cardon Rehabilitation Products, Inc.1995-05-25
AUDIOTECH MODEL SPI (K950963)Muskogee Regional Hearing Aid Lab1995-05-25
PROSYS LEG BAG (K951945)Convatec, A Division of E.R. Squibb & Sons1995-05-25
JAI (K951513)Intl. Trade Management Co.1995-05-25
MINI S.F.T. (URINE PRESERVATIVE) (K943466)Cambridge Diagnostic Products, Inc.1995-05-24
DENTAL 911 (K941066)L.A.F. Industries, Inc.1995-05-24
ORTHODONTIC ELASTOMERIC LAGATURE MODULE (K943419)Jon-Ko Products, Inc.1995-05-24
IM512P (K945792)Globus Industries1995-05-24
RIONET HM-02 (K943808)Rockwin Corp.1995-05-24
SUNBLOCKER SUNGLASSES (K950807)Blublocker Corp.1995-05-24
SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN (K926496)Sil-Med Corp.1995-05-24
ORTHODONITC ELASTOMERIC SLEEVING (K943421)Jon-Ko Products, Inc.1995-05-23
ORTHODONTIC ELASTOMERIC CHAIN (K943420)Jon-Ko Products, Inc.1995-05-23
BAND SEATER (K951776)Ormco Corp.1995-05-23
SAFE-TIPS EZ (K951238)Safe Wave Products, Inc.1995-05-23
ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (K943418)Jon-Ko Products, Inc.1995-05-23
CONAIR BODY AND SOLE (K950410)Conair Corp.1995-05-23
ORTHODONTIC ELASTOMERIC TUBE/THREAD (K943417)Jon-Ko Products, Inc.1995-05-23
PROSTAT CONTROL (K943394)Quantimetrix Corp.1995-05-23
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K952014)Prima, Inc.1995-05-22
PRIMA VENTILATOR HOSES (K952010)Prima, Inc.1995-05-22
PRIMA ADULT GAS SAMPLING CIRCUITS (K952019)Prima, Inc.1995-05-22
PRIMA COAXIAL CIRCUITS (K952018)Prima, Inc.1995-05-22
PRIMA VOLUMN VENTILATORSS (K952022)Prima, Inc.1995-05-22
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (K952016)Prima, Inc.1995-05-22
PRIMA MAPLESON D CIRCUIT (K952017)Prima, Inc.1995-05-22
PRIMA CUSTOM ANESTESIA CIRCUIT (K952012)Prima, Inc.1995-05-22
PRIMA BREATHING BAGS (K952011)Prima, Inc.1995-05-22
PRIMA PEDIATRIC ANESTHESIA CIRCUITS (K952020)Prima, Inc.1995-05-22
HEMAGEN CHAGAS' KIT (EIA METHOD) (K930272)Hemagen Diagnostics, Inc.1995-05-19
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K952009)Prima, Inc.1995-05-19
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (K951064)S-E Sales & Distribution, Inc.1995-05-19
ACCUTEST (K940615)Instrumed, Inc.1995-05-19
QUICKVUE(R) CHLAMYDIA TEST (K946276)Quidel Corp.1995-05-19
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (K935807)Bio-Rad Laboratories, Inc.1995-05-19
RIB RESECTOR (K951492)United States Surgical, A Division of Tyco Healthc1995-05-18
COMFIT/BEADED SURGEON'S GLOVE (K951662)Wembley Rubber Products (M) Sdn Bhd1995-05-17
COMFIT (PINK) (K943601)Wembley Rubber Products (M) Sdn Bhd1995-05-17
SCIPOTEX/POWDER FREE EXAMINATION GLOVES (K951668)Wembley Rubber Products (M) Sdn Bhd1995-05-17
PROFEEL (K951661)Wembley Rubber Products (M) Sdn Bhd1995-05-17
AIRGUIDE STYLETTE (K950713)Polamedco, Inc.1995-05-17
SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY (K951450)Strenumed, Inc.1995-05-17
COMFIT/GREEN POWDERED EXAMINATION GLOVES (K951667)Wembley Rubber Products (M) Sdn Bhd1995-05-17
LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3 (K945651)Bio-Rad1995-05-16
ORTHO ALT MICROWELL TEST SYSTEM (K941192)Ortho Diagnostic Systems, Inc.1995-05-16
ABBOTT AXSYM II SYSTEM (K950915)Abbott Laboratories1995-05-16
DRYSLIDE COAGULASE (K950706)Difco Laboratories, Inc.1995-05-16
NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER (K951907)Navarre Biomedical , Ltd.1995-05-15
COAT-A-COUNT LH IRMA (K951748)Diagnostic Products Corp.1995-05-15
HYDRACARE ABSORBENT WOUND DRESSING (K951914)Acacia Laboratories, Inc.1995-05-15
HICHEM ALT REAGENT KIT (K951818)Hi Chem, Inc.1995-05-15
POLYSCAN DIGITAL SCANNER (K944684)Mse Medizintechnik GmbH & Co. KG1995-05-15
DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (K943929)Greenleaf Medical Systems, Inc.1995-05-15
NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (K950524)Nichols Institute1995-05-15
THE MODEL ACAPPELLA IN THE EAR HEARING AID (K943961)Telex Communications, Inc.1995-05-15
PADGETT AIR DERMATOME, MODEL A (K951085)Padgett Instruments, Inc.1995-05-15
BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 (K951749)Biocell Laboratories, Inc.1995-05-15
PACS EQUIPMENT (K943994)Rstar Image Management System1995-05-12
MECHANICAL WHEERCHAIR- ECLIPSE (K945150)Colours 'N Motion1995-05-12
PERFECT, ENT SET, PRAKTIKANT, DE LUXE (K950913)Rudolf Riester GmbH & Co. KG1995-05-12
DI-2000 (K943602)Miles Inc., Agfa Division1995-05-12
CHAMPION (K950815)Kleinfeld, Kaplan and Becker1995-05-12
RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M) (K951068)Resound Corp.1995-05-12
CRYSTAL (K951168)Crystal Optical Co., Ltd.1995-05-12
AVANTGARDE (K951847)Otto Bock Orthopedic Industry, Inc.1995-05-12
PROSYS URIHESIVE SYSTEM LA (K951530)Convatec, A Division of E.R. Squibb & Sons1995-05-12
RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C) (K951067)Resound Corp.1995-05-12
MECHANICAL WHEELCHAIR- CHALLENGER (K945149)Colours 'N Motion1995-05-12
MECHANICAL WHEELCHAIR- AVENGER (K945148)Colours 'N Motion1995-05-12
FMS HIGH FLOW ARTHRO-SHEATH (K951702)Future Medical Systems, Inc.1995-05-12
MECHANICAL WHEELCHAIR- G-FORCE (K945151)Colours 'N Motion1995-05-12
MECHANICAL WHEELCHAIR- LIL DIPPER (K945153)Colours 'N Motion1995-05-12
TREBAY IRRGATED CUTTER BLADE (K951526)Trebay Medical Corp.1995-05-12
MECHANICAL WHEELCHAIR 890.3850 (K945175)Lumex, Inc.1995-05-12
LYFO(TM) DIFFERENTIAL DISK (K945488)Microbiologics, Inc.1995-05-11
LYFO(TM) DIFFERENTIAL DISK (K945489)Microbiologics, Inc.1995-05-11
THERMAFLEX, MODEL SD 55 C.P.M.H. (K945803)Burke Neutech, Inc.1995-05-11
LYFO(TM) DIFFERENTIAL DISK (K945487)Microbiologics, Inc.1995-05-11
PS II (K943513)Washington Biotechnology1995-05-11
MED-TEC STRING RETICLE TRAY (K951601)Medtec, Inc.1995-05-11
ETHICON DRILL BIT AND DRILL GUIDE (K944590)ETHICON, Inc.1995-05-11
ROSSITER SINUS STENT (K951803)Smith & Nephew Richards, Inc.1995-05-11
ED CORP RADIATION SCREEN (K944445)Med Corp.1995-05-11
JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS (K951917)Johnson & Johnson Consumer Products, Inc.1995-05-10
LARGE MUSCLE STRENGTH GAUGE (K945630)J-Tech, Inc.1995-05-10
SUNGLASSES, NONPRESCRIPTION (K951131)Gold, Inc.1995-05-10
BENSON AND ASHLEY (K951438)Benson & Ashley, Inc.1995-05-10
ANDAL (K950823)Pt. Sarana Indoprotex1995-05-10
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