BEUDAMED
    18 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517404626·CoRoent® XLT, 8x16x30mm

    AETOS Shoulder System

    FDA UDI
    Smith & Nephew, Inc.·00885556811016·GLENOID INSERTER TIP M

    AETOS Shoulder System

    FDA UDI
    Smith & Nephew, Inc.·00885556810996·GLENOID INSERTER TIP XS

    AETOS Shoulder System

    FDA UDI
    Smith & Nephew, Inc.·00885556811023·GLENOID INSERTER TIP L

    AETOS Shoulder System

    FDA UDI
    Smith & Nephew, Inc.·00885556811009·GLENOID INSERTER TIP S

    TDM Screw Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP

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

    ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECES

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

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 29, 2016

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 29, 2016

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·March 5, 2013

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·August 8, 2014

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·February 12, 2020

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 9, 2021

    ZIMMON PANCREATIC STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 16, 2020

    Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009