14 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197051132·Bengolea Hemostatic Forceps
26.0 c...
AUVON RECHARGEABLE TENS UNIT MUSCLE STIMULATOR
FDA Adverse Event
Injury
·SHENZHEN AS-TEC TECHNOLOGY CO., LTD·Product code NGX·January 27, 2025
VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY
FDA 510(k)
FDA Unclassified
·Unknown
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 3, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 28, 2011
AUVON TENS UNIT
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024
VGXP XP INLK PRI TIB TRAY 73MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBH·August 12, 2016
MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020