BEUDAMED
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    TYPE 316L STAINLESS STEEL WIRE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Snowden-Pencer

    FDA UDI
    STERIS CORPORATION·10885403140938·Snowden-Pencer Plastics DELICATE MOSQUITO FORCE...

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011880309180·dentaform® Snap Band, tooth 46, size 9/Roth 18

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575257478·Femoral Augment, Distal

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575257454·Femoral Augment, Distal

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011880309220·dentaform® Snap, tooth 46, size 9/Roth 22

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575257461·Femoral Augment, Distal

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575257485·Femoral Augment, Distal

    IN-THE-EAR HEARING AID, MODEL CE-3

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Manual Wheelchair W54

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 880-303/21 (Sz. 3-4 - cemented lg), (8) 880-303/22 (Sz. 3-4 - cemented x-lg), (9) 880-305/11 (Sz. 5-6 - cemented sm), (10) 880-305/12 (Sz. 5-6 - cemented md), (11) 880-305/21 (Sz. 5-6 - cemented lg), (12) 880-305/22 (Sz. 5-6 - cemented x-lg), (13) 880-307/11 (Sz. 7-8 - cemented sm), (14) 880-307/12 (Sz. 7-8 - cemented md), (15) 880-307/21 (Sz. 7-8 - cemented lg), (16) 880-307/22 (Sz. 7-8 - cemented x-lg), (17) 880-309/11 (Sz. 9-10 - cemented sm), (18) 880-309/12 (Sz. 9-10 - cemented md), (19) 880-309/21 (Sz. 9-10 - cemented lg), (20) 880-309/22 (Sz. 9-10 - cemented x-lg).

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·May 7, 2025

    Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 880-303/21 (Sz. 3-4 - cemented lg), (8) 880-303/22 (Sz. 3-4 - cemented x-lg), (9) 880-305/11 (Sz. 5-6 - cemented sm), (10) 880-305/12 (Sz. 5-6 - cemented md), (11) 880-305/21 (Sz. 5-6 - cemented lg), (12) 880-305/22 (Sz. 5-6 - cemented x-lg), (13) 880-307/11 (Sz. 7-8 - cemented sm), (14) 880-307/12 (Sz. 7-8 - cemented md), (15) 880-307/21 (Sz. 7-8 - cemented lg), (16) 880-307/22 (Sz. 7-8 - cemented x-lg), (17) 880-309/11 (Sz. 9-10 - cemented sm), (18) 880-309/12 (Sz. 9-10 - cemented md), (19) 880-309/21 (Sz. 9-10 - cemented lg), (20) 880-309/22 (Sz. 9-10 - cemented x-lg).

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·April 3, 2025

    LINOX SMART PROMRI S 65

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·June 18, 2014

    DONJOY ICEMAN

    FDA Adverse Event
    Injury ·DJ ORTHOPEDICS DE MEXICO·Product code ILO·October 20, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 19, 2012

    a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025