BEUDAMED
    22 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.
    Filters Regulation: Us FDA ×

    Apollo Suture Anchor System and Titan Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741422300·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674142230060·

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925033481·SHAH MINI-GROMMET VENT TUBE .76 MM I.D. FLUOROP...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1422300·14mm H x 22mm W x 30mm L x 0 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X142230120·14mm H x 22mm W x 30mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L142230120·14mm H x 22mm W x 30mm L XLIF Trial 12 degree L...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X14223080·14mm H x 22mm W x 30mm L x 8 degrees XLIF

    Chic

    FDA UDI
    Gc Orthodontics America Inc.·E53514223000101·CHIC ROTH 022/UL3 -2T 13A 4M

    Chic

    FDA UDI
    Gc Orthodontics America Inc.·D78814223000101·CHIC ROTH 022/UL3 -2T 13A 4M

    POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NUGARD NITILE GREY COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 5, 2014

    BATHLIFT BLISS RECLINER US AB

    FDA Adverse Event
    Malfunction ·HANDICARE·Product code FNG·May 23, 2013

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·May 26, 2011

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018

    CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

    FDA Enforcement
    Class II ·Terminated·Med Tec Inc·September 6, 2017