BEUDAMED
    23 results · 22ms · 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.

    SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

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

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074037202·BONE SCREW 7040690 ILIAC 6.5X90 TI

    RMO

    FDA UDI
    Rmo, Inc.·00885797100085·QUAD HELIX ASST 5

    Pneumosure

    FDA UDI
    STRYKER CORPORATION·07613327055658·[High Flow Insufflator, Do not use if package ...

    SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STRYKER PNEUMO SURE INSUFFLATION TUBING

    FDA Adverse Event
    Malfunction ·STRYKER CORP·Product code HIF·March 27, 2019

    TESS GLENOID REVERSE HEAD DIAMETER 36

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·February 2, 2007

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 8, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 22, 2011

    PREMIUM SURGICLIP S-9.0 TITANIUM

    FDA Adverse Event
    Malfunction ·PONCE - USS·Product code GDO·May 8, 2008

    VGXP XP E1 TIB BRG RL 9X79

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·October 8, 2018

    VGXP XP E1 TIB BRG RM 9X79

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·October 8, 2018

    VGXP INTLK FEMORAL RT 70

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·October 8, 2018

    Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

    FDA Recall
    Terminated ·Stryker Corporation·Product code HIF·March 7, 2019

    Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

    FDA Enforcement
    Class II ·Ongoing·ROi Consolidated Service Center (CSC)·August 14, 2019

    Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

    FDA Enforcement
    Class II ·Ongoing·ROi Consolidated Service Center (CSC)·August 14, 2019

    Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

    FDA Enforcement
    Class II ·Terminated·Stryker Corporation·June 12, 2019

    Regard custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

    FDA Recall
    Open, Classified ·Product code KDD·March 21, 2019