BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    PHARMACY ADDITIVE SYRINGE SET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NHAC 3.0T GE P 16

    FDA UDI
    LMT Medical Systems GmbH·04260486610513·No description.

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950019953·SCISSOR SMITH WIRE CUTTING 1 BLD SERRATED 6" 15CM

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526784970·EPICOMED ELBOW SUPPORT SILVER III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257003251·M2 OA LITE BRACE, LT VAR, RT VAL, MD

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209100682·KIT, RANGE TRAUMA w' CHITOGAUZE - ORG

    LUMANOSITY CELEBRITY, MODEL 204

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    JELDENT BASIC LINE

    FDA 510(k)
    FDA Class 2 ·Dental

    DURAPHASE PENILE PROSTHESIS, CYLINDER BODUS

    FDA Adverse Event
    Malfunction ·DACOMED CORP.·Product code FAE·May 13, 1994

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 8, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007

    DRILL, LEFT HAND 1.5MM, QR

    FDA Adverse Event
    Malfunction ·ACUMED, LLC·Product code HTW·December 19, 2023

    ACUTRAK 2® MICRO TREPHINE

    FDA Adverse Event
    Malfunction ·ACUMED, LLC·Product code HTW·December 19, 2023

    MICRO REMOVAL TIP

    FDA Adverse Event
    Malfunction ·ACUMED, LLC·Product code HWC·December 19, 2023

    1.5MM EASYOUT, QR

    FDA Adverse Event
    Malfunction ·ACUMED, LLC·Product code LXH·December 19, 2023

    AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. Prescription Use: Federal law restricts the sale of this device except by or on order of a physician.

    FDA Recall
    Terminated ·Carefusion 211 Inc 22745 Savi Ranch Pkwy Yorba Linda CA 92887-4668·Product code CBK·September 8, 2011

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018