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

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RecordFirmDate
IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 (K946247)Nichols Institute1995-06-23
EVT-5000BX (K952600)U.S. Table, Inc.1995-06-22
THE HILL ADJUSTABLE P.T. MOBILIZATION TABLE (K952358)Hill Laboratories Co.1995-06-22
THE HILL ADJUSTABLE COUNTERSTRAIN TABLE (K952356)Hill Laboratories Co.1995-06-22
SPECTRUM (K952431)Freedom Designs, Inc.1995-06-22
MECHANICAL WHEELCHAIR (K952069)Grand Seating King Corp.1995-06-22
THE HILL ADJUSTABLE HA90C (K952359)Hill Laboratories Co.1995-06-22
TONGUE CLEAN (K952446)1-800-Tongues, Inc.1995-06-22
J & S WHEELCHAIRS MODELS 500, 500B, 502, 503, 504 AND 500T (K951621)J&S Associates1995-06-22
CARDON PHYSICAL THERAPY TABLE MODEL:R40194 (K951955)Cardon Rehabilitation Products, Inc.1995-06-22
SUREFLEX FILES (K951607)Dentsply Intl.1995-06-22
SURVIVAL KIT (K950357)Opportunity Resources, Inc.1995-06-22
THE HILL ADJUSTABLE 90MD (K952355)Hill Laboratories Co.1995-06-22
GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET (K952543)Neoligaments, Ltd.1995-06-22
BACKCYCLER CPM(TM) (K945690)Ergomedics, Inc.1995-06-22
THE HILL ADJUSTABLE RATH MECHANICAL TABLE (K942109)Hill Laboratories Co.1995-06-22
THE HILL ADJUSTABLE EXTEND-R TABLE (K942256)Hill Laboratories Co.1995-06-22
IMPROVED MANHATTAN II (K952455)Argosy Electronics1995-06-21
INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL (K952453)Argosy Electronics1995-06-21
LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY (K951854)Leonard Medical, Inc.1995-06-21
RYNEL MEDICAL FOAM (K951909)Rynel, Ltd. Inc.1995-06-21
EXPANDER WITH ACTIVE TONE CONTROL (K952454)Argosy Electronics1995-06-21
GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) (K951911)Commercial Resources New Mexico, Ltd.1995-06-21
GENT-L-KARE TRACHEOSTOMY TRAYS (K950851)Premium Plastics, Inc.1995-06-21
BIODERM MEDICAL HYDROGEL ISLAND DRESSING (K951166)Bioderm, Inc.1995-06-21
DUAL PURPOSE CATHETER (K945994)Universal Medical Products, Inc.1995-06-21
MICROFLOW IRRIGATION SYSTEM (K950078)Jedmed Instrument Co.1995-06-21
IMNI-II (K951983)Cottrell, Ltd.1995-06-20
CARBOMEDICS EXENDED MITRAL ROTATOR (K951368)Carbomedics, Inc.1995-06-20
NEZHAT-DORSEY THERMAL RETENTION SYSTEM (K951300)American Hydro-Surgical Instruments, Inc.1995-06-20
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT (K952246)Tri-Tech, Inc.1995-06-20
COATED TUNGSTEN EYESHIELD (K945515)Medtec, Inc.1995-06-19
ELI URINE CONTROLS (K951817)Elsohly Labs, Inc.1995-06-19
WIDEX MODEL LOGO 32 (L32) (K952229)Widex Hearing Aid Co., Inc.1995-06-19
PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT (K951332)Dade Intl., Inc.1995-06-19
LEGEND (K952441)Health Care Mfg., Inc.1995-06-19
SPYROFOAM WOUND DRESSING (K951730)Polymedica Industries, Inc.1995-06-16
CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 (K952233)Victoreen, Inc.1995-06-16
ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES (K951839)Aladan Corp.1995-06-15
ACTIC 2002 (K946169)North Atlantic Rehabilitation, Inc.1995-06-15
CARDON PHYSICAL THERAPY TABLES MODELS R28591 & R28592 (K951906)Cardon Rehabilitation Products, Inc.1995-06-15
DISPOSABLE LATEX PATIENT EXAMINATION GLOVES (K951670)Emi Groups (U.S.A.), Inc.1995-06-15
WOUND CARE MANAGEMENT KITS (K952335)Continental Medical Laboratories, Inc.1995-06-14
INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) (K950077)Par Vision Systems Corp.1995-06-14
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (K951519)Wells Johnson Co.1995-06-14
PRESSURIZER (K951988)Promedic, Inc.1995-06-14
HCI TUBE STABILIZER (K942529)Health Care Contracts, Inc.1995-06-14
SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0 (K951189)Beckman Instruments, Inc.1995-06-13
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (K952075)Bayer Corp.1995-06-13
EAR-A-GATOR (K946108)Life-Tech Intl., Inc.1995-06-13
FLEXILOG 2000 (K945069)Oakfield Instruments, Ltd.1995-06-13
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (K952266)Stebar Instrument Corp.1995-06-12
HUMID-VENT FILTER PEDI (K952084)Gibeck, Inc.1995-06-12
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 (K945800)Diagnostic Chemicals , Ltd.1995-06-09
BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING (K950685)Bioderm, Inc.1995-06-09
ABBOTT PROJECT I, SPECTRUM (K945566)Abbott Laboratories1995-06-09
OBSTI-HOOK (K951148)Onli1995-06-09
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (K946158)Incstar Corp.1995-06-09
FLEXLIFE (K952036)Mallinckrodt Medical1995-06-08
W&H 896 TOP LIGH HIGHSPEED (K944709)A-Dec, Inc.1995-06-08
LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC) (K946257)Siam Sempermed Corp., Ltd.1995-06-08
LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER (K951147)Leigh Med Tech, Inc.1995-06-08
INCASE EXTENSIBLE BAG--NON-STERILE (K951420)Alpha Surgical, Inc.1995-06-08
DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME (K946209)Med-Plastics Intl., Inc.1995-06-08
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT (K946159)Incstar Corp.1995-06-07
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT (K946157)Incstar Corp.1995-06-07
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (K951043)Promedic, Inc.1995-06-07
NASAL SEPTAL SPLINT (K952207)Smith & Nephew Richards, Inc.1995-06-07
HUMID-VENT MICRO (K951856)Gibeck, Inc.1995-06-07
VH-2000 (K951323)Health Care Mfg., Inc.1995-06-07
FAIRY WORLD INC (K951992)Fairy World, Inc.1995-06-06
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 (K944999)More Diagnostics1995-06-06
DECA DERMATOME (MICROMOTOR SYSTEM) (K945594)Depuy Intl., Ltd.1995-06-05
OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT (K952466)Olympus America, Inc.1995-06-05
KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE (K951804)KARL STORZ Endoscopy-America, Inc.1995-06-05
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT (K952263)Siemens Hearing Instruments, Inc.1995-06-05
SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE (K952228)Resound Corp.1995-06-05
KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION (K946332)KARL STORZ Endoscopy-America, Inc.1995-06-05
POWDER FREE LATEX EXAMINATION GLOVES (K950450)Rampart Glove Co.1995-06-02
BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH (K950993)John O. Butler1995-06-02
W&H 898 TOP LIGHT HIGHSPEED (K944710)A-Dec, Inc.1995-06-02
RIONET HEARING AID HM-02 (K951677)Authorized Hearing Systems, Inc.1995-06-02
W&H 798 TOP AIR TURBINE TRIPLE SPRAY (K944717)A-Dec, Inc.1995-06-02
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM (K951292)Chiron Vision Corp.1995-06-02
W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY (K944708)A-Dec, Inc.1995-06-02
MEGA MEDITEX LIMITED (K950622)Mega Meditex , Ltd.1995-06-02
W&H 795 TOP AIR TURBINE SINGLE SPRAY (K944715)A-Dec, Inc.1995-06-02
W&H 796 TOP AIR TURBINE MINI-HEAD (K944716)A-Dec, Inc.1995-06-02
DYNABITE UROLOGICAL FORCEPS (K952391)Portlyn Corp.1995-06-01
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM (K950802)International Enzymes, Inc.1995-06-01
HLT 406 (K951382)Health Care Mfg., Inc.1995-06-01
TEMPRA HEAT PACK (K951383)Tempra Technology, Inc.1995-06-01
IMMUNOASSAY DRUGS OF ABUSE CONTROLS (K952056)Medi-Tech, Inc.1995-06-01
STAPHAUREX PLUS(TM) (K945538)Murex Diagnostics Limitd1995-06-01
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (K951966)Kent Laboratories, Inc.1995-06-01
CARDON PHSICAL THERAPY TABLE MODEL R27630 (K951953)Cardon Rehabilitation Products, Inc.1995-05-31
CARDON PHYSICAL THERAPY TABLE MODEL R27108 (K951954)Cardon Rehabilitation Products, Inc.1995-05-31
OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK (K951811)Osteotech, Inc.1995-05-31
CARDON PHYSICAL THERAPY TABLE MODEL R27112 (K951952)Cardon Rehabilitation Products, Inc.1995-05-31
INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT (K951896)Siemens Hearing Instruments, Inc.1995-05-30
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