20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYSPINE UNILATERAL LEFT GUIDE S01
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024
MySpine Unilateral Guides
FDA 510(k)
FDA Class 2
·Orthopedic
K231485
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·October 25, 2025
MEDRAD MANUAL SYRINGE LOADER
FDA 510(k)
FDA Class 2
·Cardiovascular
PHILIPS PIXIUM 4343RC
FDA 510(k)
FDA Class 2
·Radiology
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 22, 2011
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 18, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·May 20, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·June 10, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 13, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 12, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024
BIOLOX DELTA, CERAMIC FEMORAL HEAD, L¸ 40/+3.5, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWY·July 5, 2016
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014