13 results
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36ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·November 18, 2020
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·November 18, 2020
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·November 18, 2020
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·February 23, 2022
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·November 18, 2020
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code JDR·January 18, 2022
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020
Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KGZ·September 29, 2009
TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.com Manufacturer: Tyco Electronics Brand Name: Elo Touch Systems Made in China Tegris system (1703.01) MAQUET GmbH & Co. KG Kehler Strabe 31 76437 Rastatt, Germany OR Table Module (1703.71) MAQUET GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intended for the following users: medical experts
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·October 2, 2013
TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.com Manufacturer: Tyco Electronics Brand Name: Elo Touch Systems Made in China Tegris system (1703.01) MAQUET GmbH & Co. KG Kehler Strabe 31 76437 Rastatt, Germany OR Table Module (1703.71) MAQUET GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intended for the following users: medical experts
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code OUG·August 19, 2013