BEUDAMED
    19 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    IRRIGATION AND SUCTION APPARATUS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Instruments

    FDA UDI
    Nuvasive, Inc.·00887517385819·ALGI Rongeur, Pituitary Medium

    Orthopanthomorgraph OP300

    FDA UDI
    PaloDEx Group Oy·06430035872282·

    Alkaline Phosphatase LiquiColor®

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498000441·For the Kinetic Quantitative Determination of A...

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978816937·SPECL 14MM/6MM WORKING CHANNEL

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490002455·SPECIAL 14 X 6 WORKING CHANNEL

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981129309·Conical Reamer

    ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECES

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 8, 2006

    AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BACKSTOP AND BACKSTOP INJECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TCP

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118332·

    CURE LP

    FDA UDI
    SpineArt SA·07640332474976·LUMBAR DRILL Ø 3,5 L20

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 27, 2014

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 7, 2013

    AQUATRACK HYDROPHILIC GUIDEWIRE

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL DEVICES, INC.·Product code DQX·October 27, 2010

    Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014

    Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    CYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" LIF (1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF (1) TUR Y SET 81 "2.1 M REGULAR CLAM (4) GAUZE SPONGES 4" X 4" 12 PLY XRD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014