BEUDAMED
    19 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 ×

    CarboClear VBR System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550131·GENUMEDI PT KNEE SUP SILVER L EW IV

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198536·AK3 Ultra Insert Trial Size 2, 14mm

    Aspida

    FDA UDI
    ALPHATEC SPINE, INC.·00840967191003·SACRAL DTS GUIDE 14MM

    CRYOPEN CRYOSURGICAL SYSTEM, K102214

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

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107996·TRIAL 90-SRK-192214 POLY-MPCS 2X14 LEFT

    ENDO FLIP

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

    CHIROPRO L SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 21, 2022

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 22, 2014

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 20, 2013

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    THREE PEG PATELLA 35MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 4, 2024

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·November 20, 2013

    VGXP XP E1 TIB BRG LL 9X71

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·February 21, 2018

    VGXP XP E1 TIB BRG LM 9X71

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·February 21, 2018

    VGXP XP INLK PRI TIB TRAY 73MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·February 21, 2018

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013