8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCUPACH V
FDA 510(k)
FDA Class 2
·Radiology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 24, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·August 27, 2008
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 23, 2011
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 16, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025