BEUDAMED
    17 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

    Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ00/0-R

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

    FDA Enforcement
    Class II ·Ongoing·OPTI Medical Systems, Inc·August 25, 2021

    Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

    FDA Enforcement
    Class II ·Ongoing·Btt Health Gmbh·September 25, 2024

    Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·December 7, 2016

    HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 15, 2017

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·May 15, 2024

    1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·February 2, 2022

    Intelli-C, Left side suspended Tabletop, REF: 03400010

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

    Intelli-C, Right side suspended Tabletop, REF: 03400000

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018