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

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    KIMBERLY-CLARK CHILD'S FACEMASK

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

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950017515·RETRACTOR SURGICAL CURVED UP 13X45MM 8-1/2" 21CM

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517564269·CoRoent Ant TLIF PEEK, 11x13x34mm 0°

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169605381·SPACER 2113340 OLIF25 20MM 18 DEG 12X40

    Pilot Spinal System

    FDA UDI
    Life Spine, Inc.·00190837051426·Pilot Construct Caddy

    SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RT-PLUS KNEE ADDITIONAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUADRA H FEMORAL CEMENTLESS STEM SIZE 3 LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JDI·October 31, 2013

    CORAIL2 LAT COXA VARA SIZE 10

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 15, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    AVALON FETAL MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code HGM·May 28, 2011

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    PKG, SPRING HANDLE, P/N 0250080237. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021