BEUDAMED
    12 results · 25ms · 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.

    UNI-GOLD STREP A TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    N/A

    FDA UDI
    Key Scientific Products Incorporated·00850041798028·PEP REAGENT

    N/A

    FDA UDI
    Key Scientific Products Incorporated·00850041798042·Pep ReagentT

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code GDO·May 1, 1998

    PowerLook Tomo Detection V2 Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    NORAS MR-BI320-PA 3T

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFINITY DENTAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·ACE SURGICAL SUPPLY CO.·Product code DZE·February 25, 2013

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NEK·February 9, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 5, 2014

    TELESCOPIC STRUT MEDIUM HOFFMANN LRF LENGTH: 138-201MM (BLUE)

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA SELZACH·Product code KTT·December 26, 2013

    IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.

    FDA Recall
    Terminated ·Numed Inc·Product code LIT·September 23, 2009

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024