153 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
FDA Recall
Open, Classified
·Nihon Kohden America Inc·Product code DRG·January 8, 2021
FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code KOO·June 23, 2022
FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code KOO·October 4, 2023
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
FDA Recall
Terminated
·Remel Inc·Product code GTY·June 30, 2015
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.
FDA Recall
Terminated
·Ge Healthcare It·Product code LLZ·June 15, 2012
A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.
FDA Recall
Terminated
·Alto Development Corp·Product code LDF·June 21, 2019
GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05
FDA Recall
Terminated
·GE Medical Systems Information Technologies·Product code LLZ·July 18, 2005
Triathlon TS Femoral Trial; Size 5 Right Non-Sterile Catalog Number: 5512-T-502 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 6 Left Non-Sterile Catalog Number: 5512-T-601 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 8 Right Non-Sterile Catalog Number: 5512-T-802 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 3 Left Non-Sterile Catalog Number: 5512-T-301 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 1 Right Non-Sterile Catalog number: 5512-T-102 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 7 Right Non-Sterile Catalog Number: 5512-T-702 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 2 Left Non-Sterile Catalog Number 5512-T-201 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial Size 3 Right Non-Sterile Catalog Number : 5512-T-302 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 5 Left Non-Sterile Catalog Number: 5512-T-501 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 7 Left Non-Sterile Catalog Number: 5512-T-701 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 4 Left Non-Sterile Catalog Number: 5512-T-401 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 2 Right Non-Sterile Catalog Number: 5512-T-202 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008
Triathlon TS Femoral Trial; Size 1 Left Non-Sterile Catalog number 5512-T-101 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·March 5, 2008