BEUDAMED
    45 results · 11ms · Sources: EU EUDAMED, US FDA

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    Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

    FDA Recall
    Terminated ·Bion Enterprises Ltd·Product code GQH·January 23, 2013

    ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-04001-SUH and ASK-04001-UHC. Access tray for epidural anesthesia kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·October 29, 2010

    PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J +6MM; and

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J BOTTOM, +6MM TASP R CD BOTTOM, +0MM TASP R CD BOTTOM, +6MM TASP R EF BOTTOM, +0MM TASP R EF BOTTOM, +6MM TASP R GH BOTTOM, +0MM TASP R GH BOTTOM, +6MM TASP R J BOTTOM, +0MM TASP R J BOTTOM, +6MM

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top; Right Size 3-5 EF Top; Right Size 6-9 EF Top; Right Size 10-11 EF Top; Right Size 6-9 GH Top; Right Size 10-12 GH Top; and Right Size 10-12 J Top.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS TIB SZ 3 C/D, 17MM - 00588605317 TM LPS TIB SZ 4 C/D, 10MM - 00588605410 TM LPS TIB SZ 4 C/D, 12MM - 00588605412 TM LPS TIB SZ 4 C/D, 14MM - 00588605414 TM LPS TIB SZ 5 E/F 10 MM - 00588605510 TM LPS TIB SZ 5 E/F, 12MM - 00588605512 TM LPS TIB SZ 5 E/F, 14MM - 00588605514 TM LPS TIB SZ 5 E/F, 17MM - 00588605517 TM LPS TIB SZ 6 E/F, 10MM - 00588605610 TM LPS TIB SZ 6 E/F, 12 mm - 00588605612 TM LPS TIB SZ 6 E/F, 17MM - 00588605617 TM LPS TIB SZ 7 G/H, 10MM - 00588605710 TM LPS TIB SZ 7 G/H, 12MM - 00588605712 TM LPS TIB SZ 7 G/H, 14MM - 00588605714 TM LPS TIB SZ 8 G/H, 10MM - 00588605810 TM LPS TIB SZ 8 G/H, 12MM - 00588605812 TM LPS TIB SZ 8 G/H, 14MM - 00588605814 TM LPS TIB SZ 8 G/H, 14MM - 00588605814 TM LPS TIB SZ 8 G/H, 17MM - 00588605817 TM LPS TIB SZ 3 E/F, 10MM - 00588606310 TM LPS TIB SZ 3 E/F, 12MM - 00588606312 TM LPS TIB SZ 3 E/F, 14MM - 00588606314 TM LPS TIB SZ 3 E/F, 17MM - 00588606317 TM LPS TIB SZ 4 E/F, 10MM - 00588606410 TM LPS TIB SZ 4 E/F, 12MM -00588606412 TM LPS TIB SZ 4 E/F, 14MM - 00588606414

    FDA Enforcement
    Class II ·Terminated·Zimmer Trabecular Metal Technology, Inc.·June 22, 2016

    Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH BOTTOM +6MM PSN A/S PROV L J BOTTOM +0MM PSN A/S PROV L J BOTTOM +6MM PSN A/S PROV R CD BOTTOM +0MM PSN A/S PROV R CD BOTTOM +6MM PSN A/S PROV R EF BOTTOM +0MM PSN A/S PROV R EF BOTTOM +6MM PSN A/S PROV R GH BOTTOM +0MM PSN A/S PROV R GH BOTTOM +6MM PSN A/S PROV R J BOTTOM +0MM PSN A/S PROV R J BOTTOM +6MM

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.

    FDA Enforcement
    Class II ·Terminated·Orthosensor, Inc.·October 17, 2018

    OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.

    FDA Enforcement
    Class II ·Terminated·Orthosensor, Inc.·October 17, 2018

    PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Left Size 3-9 CD Top; Left Size 3-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp., Minneapolis, MN 55411

    FDA Recall
    Terminated ·Coloplast Corp·Product code FQH·November 12, 2007

    Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

    FDA Recall
    Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

    Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP 150, ASP 145, ASP 180, Coloplast Corp., Minneapolis, MN 55411

    FDA Recall
    Terminated ·Coloplast Corp·Product code FQH·November 12, 2007

    Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

    FDA Recall
    Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

    Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers: ASP 165, ASP 170, Coloplast Corp., Minneapolis, MN 55411

    FDA Recall
    Terminated ·Coloplast Corp·Product code FQH·November 12, 2007

    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FQH·May 8, 2015