BEUDAMED
    21 results · 19ms · Sources: EU EUDAMED, US FDA

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    STERILE TRACHEOSTOMY TRAY

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

    ZAVATION

    FDA UDI
    Zavation LLC·00842166190917·Polyaxial Reduction Screw 4.0x30

    Solstice Occipito-Cervico-Thoracic System

    FDA UDI
    Life Spine, Inc.·00190837022150·4.0mm SOLSTICE® Smooth Shaft Poly Screw, 30mm

    Ophthalmic Spoon

    FDA UDI
    KATENA PRODUCTS, INC.·00841668103456·NEW ORLEANS LENS LOOP

    Monkey Rings™ External Fixation System

    FDA UDI
    Paragon 28, Inc.·00889795129635·Steinman Pin, Drill Tip, Ø4.0mm x 230mm, AO

    APOGEE ELITE

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

    Clear Guide SCENERGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·February 6, 2017

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 30, 2013

    LIGAMAX-5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·December 21, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 15, 2014

    VANGUARD DA360 TIBIAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 14, 2017

    VANGUARD SSK 360 FEMUR R 67.5

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·June 9, 2017

    VANGUARD DA360 TIBIAL BEARING 63/67X18

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 7, 2016

    BIOMET 360 OFFSET ADAPTER 2.5MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·June 9, 2017

    BIOMET SMOOTH KNEE STEM 12X40

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·June 9, 2017

    VANGUARD DA 360 TIBIAL BEARING ARCOM 63/67X18

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·June 9, 2017

    VANGUARD DA 360 O/S TIBIAL TRAY COCR 67

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·June 9, 2017

    VANGUARD 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 27, 2017

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, REF 130-36-53 d. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 4 CUPS, REF 130-36-54 e. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 5 CUPS, REF 130-36-55 f. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 3 CUPS, REF 136-32-53 g. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 4 CUPS, REF 136-32-54 h. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 5 CUPS, REF 136-32-55 i. NOVATION GXL LINER, +5LAT, 28MM G1-48/50MM CUPS, REF 136-28-51 j. NOVATION GXL LINER, +5LAT, 32MM G1-48/50MM CUPS, REF 136-32-51 k. NOVATION GXL LINER, +5LAT, 32MM G2-52/54MM CUPS, REF 136-32-52 l. NOVATION GXL LINER, +5LAT, 36MM G2-52/54MM CUPS, REF 136-36-52 m. NOVATION GXL LINER, +5LAT, 36MM G3-56/58MM CUPS, REF 136-36-53 n. NOVATION GXL LINER, +5LAT, 36MM G4-60/62MM CUPS, REF 136-36-54 o. NOVATION GXL LINER, +5LAT, 36MM G5-64/66/68MM CUPS, REF 136-36-55 p. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 1 CUP, REF 138-32-51 q. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 3 CUP, REF 138-32-53 r. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 2 CUP, REF 138-36-52 s. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 3 CUP, REF 138-36-53 t. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 4 CUP, REF 138-36-54 u. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 5 CUP, REF 138-36-55 v. NOVATION GXL LINER, 10 DEG FACE, REPLACED BY 138-36-52, REF 138-32-52 w. NOVATION GXL LINER, LIPPED 32MM ID GROUP 2 CUPS, REF 132-32-52 x. NOVATION GXL LINER, LIPPED ANT, 32MM ID, GROUP 1 CUPS, REF 132-32-61 y. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 2 CUPS, REF 132-36-62 z. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 3 CUPS, REF 132-36-63 aa. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 4 CUPS, REF 132-36-64 bb. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 3 CUPS, REF 132-36-53 cc. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 1 CUPS, REF 132-28-51 dd. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 2 CUPS, REF 132-28-52 ee. NOVATION GXL LINER, LIPPED, 32MM ID GROUP 4 CUPS, REF 132-32-54 ff. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 3 CUPS, REF 132-32-53 gg. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 5 CUPS, REF 132-32-55 hh. NOVATION GXL LINER, LIPPED, 36MM ID GROUP 4 CUPS, REF 132-36-54 ii. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 5 CUPS, REF 132-36-55 jj. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 2 CUPS, REF 130-28-52 kk. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 3 CUPS, REF 130-32-53 ll. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 4 CUPS, REF 130-32-54 mm. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 5 CUPS, REF 130-32-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022