BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    NOMOS STEREOTACTIC BIOPSY INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Neurology

    LP Low Profile

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746091506·DB BKT LP V-SLOT LL CUSP 018 T-3 A+6 R3M

    OMNI Knee

    FDA UDI
    Omni Life Science, Inc.·00841690101512·Ultra Tibial Insert CS, Size 1 x 20mm

    FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET

    FDA 510(k)
    FDA Class 2 ·Radiology

    BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·January 30, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 22, 2010

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 15, 2014

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 5, 2015

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 9, 2015

    HARMONIC ACE 36CM W ERG HANDLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 30, 2018

    Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile; (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile; (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile; (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile; (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile; (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile; (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile; (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile; (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile; (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile; (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile; (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile; (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile; (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile; (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile; (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile; (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile; (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile; (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile; (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile; (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile; (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile; (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile; (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile; (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile; (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile; (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile; (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile; (32) Presource EVAR, Cat. SCV30EVTHE, Trillium Health Centre, Sterile; (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile; (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 18, 2023