12 results
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12ms
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Sources: EU EUDAMED, US FDA
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
FDA Recall
Open, Classified
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code OSR·April 6, 2021
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FSY·November 8, 2023
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
FDA Recall
Open, Classified
·Product code KIE·October 9, 2024
Atrium Pneumostat Chest Drain Valve, Part Number 16100
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code KDQ·August 26, 2021
3mensio Workstation (Vascular Fenestrated) software
FDA Recall
Open, Classified
·PIE Medical Imaging B.V. Demertdwarsstraat 8A01 Maastricht Netherlands·Product code LLZ·July 14, 2025
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
FDA Recall
Open, Classified
·CORENTEC CO., LTD 12 Yeongsanhong1-Gil; Seobuk Cheonan Korea (the Republic of)·Product code JWH·March 29, 2024
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
FDA Recall
Open, Classified
·CORENTEC CO., LTD 12 Yeongsanhong1-Gil; Seobuk Cheonan Korea (the Republic of)·Product code JWH·March 29, 2024
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
FDA Recall
Open, Classified
·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·March 31, 2023
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
FDA Recall
Open, Classified
·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·January 31, 2022
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025