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

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RecordFirmDate
IV SECUREMENT DEVICE (K870020)Avery Intl.1987-02-04
ADX(TM) ANALYZER (K864566)Abbott Laboratories1987-02-04
IV SECUREMENT DEVICE USING HYTREL THERMO. FILM (K870090)Avery Intl.1987-02-04
T1365 (BIRD SEED AGAR SLANT) (K870057)Lakewood Biochemical Co., Inc.1987-02-04
ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE (K864522)Beckman Instruments, Inc.1987-02-04
UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE (K863442)United Biotech, Inc.1987-02-04
COOK-VPI CONTINENCE CUFF (K863227)Cook Urological, Inc.1987-02-03
PENLON CIRCLE SYSTEM (K864588)Bear Medical Systems, Inc.1987-02-03
FEMUR WRENCH (K870126)Orthopedic Systems, Inc.1987-02-03
LEECO VIS-CUBE STREP A (EIA) (K864170)Leeco Diagnostics, Inc.1987-02-03
TUPPER TROLLEY (K870102)Orthopedic Systems, Inc.1987-02-03
THE GOLDEN QUAD TEST (EBV) (K861121)Microbiological Research Corp.1987-02-02
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA (K864347)Granbio, Inc.1987-02-02
LYMPHOCYTE MAINTENANCE MEDIUM (K864396)Bioclinical Laboratory Services, Inc.1987-02-02
EBV VCA IGM ANTIBODY ASSAY KIT (K864604)Granbio, Inc.1987-02-02
ALFERR TIBC TUBE (K864548)Benchmark Reagents1987-02-02
REVISED T-SCAN SYSTEM (K870032)Sentek, Inc.1987-02-02
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM (K864663)Kallestad Diag, A Div. of Erbamont, Inc.1987-02-02
NTE-2 THERMAL SENSITIVITY TESTER (K864345)Sensortek, Inc.1987-01-29
GUO GUANG WHEEL CHAIR (K870043)China National Medicines & Health Prod. I/E Corp.1987-01-28
RD 140 SURGICAL BENDER (K870084)Terray Manufacturing, Inc.1987-01-28
PLASTER STAND (K870100)Orthopedic Systems, Inc.1987-01-28
'EXMOOR' SHAH SILICONE DISCS (K864934)Exmoor Plastics , Ltd.1987-01-28
HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST (K864929)Hall Surgical, Division of Zimmer, Inc.1987-01-28
REGULATOR OXYGEN MECHANICAL (K863711)Lifeguard Medical Products, Inc.1987-01-27
BECKMAN EPSILON(TM) PROLACTIN TEST KIT (K864439)Beckman Instruments, Inc.1987-01-21
FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY (K864882)Pointe Scientific, Inc.,1987-01-21
RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR (K864827)Tactilitics, Inc.1987-01-21
PENOX HOSPITAL BED (K864667)Penox Technologies, Inc.1987-01-21
WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE (K864953)Dittmar and Penn Corp.1987-01-21
WELLCOZYME ROTAVIRUS WZ01 (K861628)Wellcome Diagnostics1987-01-21
TOSHIBA, SMIT ROENTGEN (K870071)North American Imaging, Inc.1987-01-21
LEAD APRON CADDY (K870103)Orthopedic Systems, Inc.1987-01-21
KROM-X LENS SYSTEM (K865103)Neo Optics, Inc.1987-01-20
ROD, IRRIGATOR, SUPPORTING TELESCOPING, TYPE (K863688)Brenner Metal Prod Corp.1987-01-20
LIDSPLINT (K864810)Precision Therapeutics, Inc.1987-01-20
BACK REST, LITTER, NON-ADJUSTABLE (K863686)Brenner Metal Prod Corp.1987-01-20
DUALENZ LOW VISION EYEWEAR (K864594)Global Eye Care, Inc.1987-01-20
COT, FOLDING, HOSPITAL, ALUMINUM (K863691)Brenner Metal Prod Corp.1987-01-20
MODIFIED DEVICE FOR SELF EXAMINATION OF EYES (K863429)Wheel Checkers1987-01-20
FREE SPIRIT(TM) I.V. STAND (K864753)Demstar Corp.1987-01-20
SPORTLIFE SUNWEAR (K863886)North American Vacuum Coating Co.1987-01-20
BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON (K864520)Precision Instruments, Inc.1987-01-20
BED/ADJUST/HOSPITAL/FOLDING FIELD WITHOUT MATTRESS (K863694)Brenner Metal Prod Corp.1987-01-20
APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC (K864393)Intl. Diagnostic Laboratories, Ltd.1987-01-16
VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (K864822)Surgidyne, Inc.1987-01-15
SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE (K865046)Salter Labs1987-01-15
CART, ORTHOPEDIC BED, STRYKER (K863685)Brenner Metal Prod Corp.1987-01-15
SAFE-T-SHIELD MOUTHPIECE (K865093)Medi Nuclear Corp., Inc.1987-01-15
BAYER HEALTHCARE RAPIDQC PLUS (K870036)Ciba Corning Diagnostics Corp.1987-01-14
PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT (K862483)Pantex, Div. Bio-Analysis, Inc.1987-01-14
LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS (K864383)Luxtec Corp.1987-01-14
FRAZIER SUCTION TUBE (K864382)Luxtec Corp.1987-01-14
E-Z HOLD - #4060 (K864190)John F. Greer Co., Inc.1987-01-14
LAD MODEL 535 LUMINOMETER (K864201)Los Alamos Diagnostics1987-01-13
CHEMTROL(TM) (K862565)G.B.F. Industries, Inc.1987-01-13
H-H SUBGALEAL TROCAR (K865075)Holter-Hausner Intl.1987-01-13
PEG 6,000 (K863103)J. D. Assoc.1987-01-13
REVEAL COLOUR STREP A ZL16 (K864206)Wellcome Diagnostics1987-01-13
OHMEDA 6000 MULTI-GAS MONITOR (K863959)Ohmeda Medical1987-01-12
COVER, SHOE OPERATING ROOM (K865023)Ulti-Med Intl., Inc.1987-01-12
TISSUE-EQUIVALENT BREAST SIMULATOR (K865100)Computerized Imaging Reference Systems, Inc.1987-01-12
ARNOLD-KING PRESSURE DRESSING (K864688)Angiosystems, Inc.1987-01-12
BOARD, ARM (WITH COVER) (K864670)Anago, Inc.1987-01-12
SCANLAN (TM) INSTRUMENT TRAY (K864920)Scanlan Intl., Inc.1987-01-12
DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 (K864897)Dale Medical Products, Inc.1987-01-12
SURGICAL GARMENTS (K865022)Ulti-Med Intl., Inc.1987-01-12
ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER (K865024)American Container Technology, Inc.1987-01-12
SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) (K864267)Millipore Corp.1987-01-09
GENERAL PURPOSE CENTRIFUGE (K864974)Norfolk Scientific, Inc.1987-01-09
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II (K865014)Bio-Rad1987-01-09
TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS (K861202)Nms Pharmaceuticals, Inc.1987-01-09
ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (K864966)Diagnostics Biochem Canada, Inc.1987-01-09
SPECULUM, VAGINAL, METAL FIBEROPTIC (K864865)Luxtec Corp.1987-01-09
UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS (K864277)Unimax Hearing Instruments1987-01-09
WAKO(TM) AUTOKIT GPT (K864850)Wako Chemicals USA, Inc.1987-01-09
TERUMO OVATION SPECTROPHOTOMETER (K864285)Terumo Medical Corp.1987-01-09
AMOENA BREAST FORMS (K864785)Coloplast Corp.1987-01-08
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT (K864786)Coloplast Corp.1987-01-08
DUOCEPH (K864527)Gary E. Hall, Dds1987-01-07
THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (K863610)Ob/Gyn Concepts, Ltd.1987-01-07
FYODOROV COLLAGEN CORNEAL SHIELD (K862315)Medical Technology Development Corp.1987-01-07
ARTHROPHONOMETER (K862286)Arthrotek, Inc.1987-01-07
TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 (K864535)Concord Laboratories, Inc.1987-01-06
BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1 (K864823)Bernafon, Inc.1987-01-06
ICU/CPU TRANSPORT TRAY (K864878)Orthopedic Systems, Inc.1987-01-06
CANWEST OVU-BLUE (K862055)Canwest Medictex, Inc.1987-01-06
TRACHEOBRONCHIAL SUCTION CATHETER (K864468)Sheridan Catheter Corp.1987-01-06
DUFFY BOLUS INJECTOR (K863936)Viox Corp.1987-01-06
RAICHEM(TM) AMMONIA REAGENT (K864706)Reagents Applications, Inc.1987-01-05
LKB 2260 MACROTOME (K864733)Lkb Instruments, Inc.1987-01-05
CULT-UR (K864727)R.P. Laboratories, Inc.1987-01-05
BONE MARROW COLLECTION MEDIUM (K864740)Bioclinical Laboratory Services, Inc.1987-01-05
PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM (K864755)Gibco Laboratories Life Technologies, Inc.1987-01-05
S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS (K864817)S & W Enterprises, Inc.1987-01-05
MICRODILUTION IDENTIFICATION PANELS (K864674)American Micro Scan1987-01-05
ALANINE AMINO TRANSFERASE ALT/SGPT (K864906)Tech-Co, Inc.1986-12-31
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS (K864776)Bartels Immunodiagnostic Supplies, Inc.1986-12-31
DERMATEC TRANSPARENT FILM DRESSING (K863580)Dermatec, Inc.1986-12-31
MAGNESIOMETER (K863069)J. D. Assoc.1986-12-31
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