BEUDAMED
    16 results · 36ms · Sources: EU EUDAMED, US FDA

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    Akros FibuLink™ Syndesmosis Repair Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169600126·TRIAL 2173550 O25 IB 20MM 18 DEG 16X50

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668109007·VISCOELASTIC ASPIRATING CANNULA 22GA

    YOBOSHI DENTAL UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TINBN VANGUARD INT PS ANAT FM R 65MM

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·March 7, 2025

    VGXP XP MED TIB BRG LT 10X63

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·March 2, 2018

    VANG XP INLK FEMORAL L52.5

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·March 2, 2018

    VANG XP INLK PRI TIB TRAY 63MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·March 2, 2018

    11 CM ANGLE ATTACHMENT QD11

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 15, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 17, 2013

    LUCAS 3 CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

    LUCAS 3 CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

    MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR LIF (5) LAP SPONGE PREWASH XRD L/F (4) DRAPE UTILITY WITH TAPE LIF (2) LITES GLOVE LIF (1) TUBE SUCTION CONNECT. ~" X 12' LIF (1) COVER MAYO STAND REINFORCED LIF (1) UTILITY BOWL 32oz (2) UTILITY BOWL 16oz (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL #10 CARBON STEEL (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BAG SUTURE FLORAL (1) DRAPE SHEET MEDIUM 41" X 69" LIF (1) DRAPE LAP WITH POUCH SMS STD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020