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

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RecordFirmDate
TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM (K884600)Technicon Instruments Corp.1989-01-23
DISCARD DENTAL EXPLORER (K885217)Wen Hao, Inc.1989-01-19
ETV, ELECTRONIC VISION AID (K884540)Sevrain-Tech, Inc.1989-01-19
VORTECH'S MEDICAL IMAGING GATEWAY (K884434)Vortech Data, Inc.1989-01-19
DENTAL DRESSING PLIERS (K885219)Wen Hao, Inc.1989-01-19
RACESTYPTINE (K884653)Specialites Septodont1989-01-19
DISCARD DENTAL MIRROR (K885218)Wen Hao, Inc.1989-01-19
NON-STERILE VINYL GLOVES (K885346)Daw Shin Industrial Co., Ltd.1989-01-18
BTE HEARING AID SIEMENS MODEL 284PP-ASP (K884583)Siemens Hearing Instruments, Inc.1989-01-18
CRUCIOMETER (K884483)Orthopedic Systems, Inc.1989-01-18
FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT (K884708)Cyberfluor, Inc.1989-01-17
FR6000 FLOWMETER (K884973)Key Instruments1989-01-17
ESP 3-PHASE X-RAY GENERATORS (K884678)Elscint, Inc.1989-01-17
THORACIC SUPPORT SYSTEM (K883214)Storer Medical Products1989-01-17
MAGNESIUM TEST ITEM NUMBER: SR1019 (K885022)Em Diagnostic Systems, Inc.1989-01-17
TECNOL VARIABLE TENSION BANDAGE (K884440)Tecnol New Jersey Wound Care, Inc.1989-01-17
ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID (K882633)Ensoniq Corp.1989-01-13
MCCONNELL REAMER GUIDE (K885100)Mcconnell Orthopedic1989-01-13
FITC MURINE MONOCLONAL ANTI-RSV IGG (K884516)Whittaker Bioproducts, Inc.1989-01-13
LINCOLN MILLS HIP HOLDER (K885215)Lincoln Mills, Inc.1989-01-13
PROMO-RIST C.P.M. (K881314)Professional Motion, Inc.1989-01-13
ELECTR-TRANSBLOTTER (K882344)The W.E.P. Co.1989-01-13
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664 (K884988)Em Diagnostic Systems, Inc.1989-01-13
CORTRONIC SCR1000 (K884911)Cortronic Corp.1989-01-13
MICROSCOPE SLIDES PRECOATED (K890042)Stat Path1989-01-13
THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM (K885088)Thayer Medical Corp.1989-01-12
HEAD HOLDING DEVICE/SLEEP APNEA (K884493)X-Ray Systems1989-01-12
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC) (K884189)Eastman Kodak Company1989-01-11
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652 (K884376)Em Diagnostic Systems, Inc.1989-01-11
DENTAL MIRROR RETRACTOR (K885040)Nu-Lite Retractor, Inc.1989-01-10
TAMPAX ULTRAFIT PANTY SHIELDS (K884950)Tambrands, Inc.1989-01-10
BENDA BRUSH (K885162)Centrix, Inc.1989-01-10
CONSED FECAL CONCENTRATION SYSTEM (K884755)Donald L. Price, Ph.D.1989-01-10
BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED (K884515)Gatewood and Associates, Ltd.1989-01-10
EDENTEC MODEL 4700 SCANNER (K884388)Edentec Corp.1989-01-10
TIN COATED NITI ORTHODONTIC ARCH WIRES (K885086)Flexmedics1989-01-10
ATS MAYER'S ALBUMIN (K890022)Alpha-Tec Systems, Inc.1989-01-10
MTD HEDREST (K884847)Composites Horizons, Inc.1989-01-09
KIT PAK SUCTION CATHETER KIT (K885131)Kit Pak, Inc.1989-01-09
LATEX SURGICAL GLOVES (K884499)Yuli Corp., Inc.1989-01-09
GAUZE BANDAGE 1 X 6 YDS. (K884334)North Health Care1989-01-09
GAUZE BANDAGE 2 X 6 YDS. (K884333)North Health Care1989-01-09
RENALIN COLD STERILANT (K882564)Minntech Corp.1989-01-09
SAMPLE IDENTIFICATION STATION MODEL 38010 (K884269)Icn Micromedic Systems1989-01-09
GAUZE BANDAGE 4 X 6 YDS. (K884335)North Health Care1989-01-09
LATEX SURGICAL GLOVE (K881664)Lien Chang Rubber Industrial Co., Ltd.1989-01-06
MODEL 200A ELECTRONIC FORCE-SENSING PROBE (K884813)Vine Valley Research1989-01-05
GY-RO SAFE (K883785)Gy-Ro Industry, Inc.1989-01-05
ONCOPROBE SYSTEM (K884770)Care Wise Medical Products Corp.1989-01-04
TWIXEL(TM) (K885056)Fouts Development, Inc.1989-01-04
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST (K883935)Ortho Diagnostic Systems, Inc.1989-01-04
BERICHROM(R) PLASMINOGEN (K884766)Behring Diagnostics, Inc.1989-01-04
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST (K883940)Ortho Diagnostic Systems, Inc.1989-01-04
AUTOMATED EIA READER MODEL EL311 (K884124)Bio-Tek Instruments, Inc.1989-01-03
HEARING AID, UNITRON BTE MODEL UM60-AGC0 (K884288)Unitron Industries, Inc.1989-01-03
ALANINE AMINOTRANSFERASE (K884936)Catachem, Inc.1989-01-03
DIOPTICS EYESHIELDS (K885163)Dioptics1988-12-30
VIRGO(R) MICROWELL ALT ASSAY (K884784)Electro-Nucleonics, Inc.1988-12-29
SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER (K884035)Sclavo, Inc.1988-12-29
EDENTRACE MULTI-CHARTER MODEL 3700 (K883315)Edentec Corp.1988-12-28
CELL SCRAPER (K885121)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-12-28
ULTRAFLOTATION MEDICAL WHEELCHAIR (K884908)Medical Flotation Systems, Inc.1988-12-27
SLIDING ARM SUPPORT (K885105)Rolcontrol Products, Co., Inc.1988-12-27
MODIFIED Q-SERIES OF TREADMILLS (K885062)Quinton, Inc.1988-12-27
ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (K884862)Anchor Products Co.1988-12-27
LAYDOWN ARM SUPPORT MECHANISM (K885104)Rolcontrol Products, Co., Inc.1988-12-27
REMOVABLE BATTERY POWER SYSTEM (K885106)Rolcontrol Products, Co., Inc.1988-12-27
BUMPY MEDICAL MASSAGE MAT (K884907)Medical Flotation Systems, Inc.1988-12-27
SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD (K885042)Sony Medical Electronics Co.1988-12-22
COTUBE LH IRMA ASSAY (K884498)Bio-Rad1988-12-22
OCCLUSAL HARMONY IMPRESSION TRAY (K884316)Advantage Dental Co.1988-12-22
LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE (K884403)Supelco, Inc.1988-12-22
INDENTEC DRILL RA #1 (K884187)Phillip C. Crawford, D.D.S.1988-12-22
AD POST (K884277)J. Morita USA, Inc.1988-12-22
GROUP A STREP, BETA-STREP (K884750)Ampcor, Inc.1988-12-22
ROCKET INTRAUTERINE DEPTH SOUND (K884684)A & A Medical, Inc.1988-12-20
HEARING AID WIDEX BTE (K884113)Widex Hearing Aid Co., Inc.1988-12-19
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST (K883530)Tambrands, Inc.1988-12-19
GONIOMETER AND BIOMEDICAL RECORDER SYSTEM (K884003)Penny & Giles Blackwood , Ltd.1988-12-19
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION (K885006)Abbott Laboratories1988-12-16
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE) (K884355)Eastman Kodak Company1988-12-16
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 (K883615)Supelco, Inc.1988-12-16
PHOSPHORUS TEST (PHOS) ITEM #65666 (K884735)Em Diagnostic Systems, Inc.1988-12-16
PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT (K884525)Intertech/Ohio1988-12-16
HDL-CHOLESTEROL PRECIPITATING REAGENT (K883543)Medical Analysis Systems, Inc.1988-12-16
ABC FP ANALYZER (K883533)Intl. Bioclinical, Inc.1988-12-15
ALLEN PRONE ARMBOARD (K884838)Edgewater Medical Systems, Inc.1988-12-15
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) (K884424)Bio-Rad1988-12-15
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST (K882440)Zeus Scientific, Inc.1988-12-15
S 4 INSTRUMENT STAND (K884876)Carl Zeiss, Inc.1988-12-15
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES (K882447)Zeus Scientific, Inc.1988-12-15
JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE (K884749)Johnson & Johnson Patient Care, Inc.1988-12-15
FREE ARM(TM) (K884928)Faro Medical Technologies, Inc.1988-12-15
TAB PAK (K882731)Dynex Trading Co.1988-12-14
TOTAL IRON BINDING CAPACITY TEST (K884649)Sclavo, Inc.1988-12-14
VERSABLOT (K884258)American Bionetics, Inc.1988-12-14
WASHER 500 MICROELISA SYSTEM (K884695)Organon Teknika Corp.1988-12-13
SANIFIX (K883983)Iberhospitex, S.A.1988-12-13
IRRIGATION KIT (K883506)L H M Ent., Inc.1988-12-13
CFX 625 (K883976)Fischer Imaging Corp.1988-12-13
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