14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STIMUPLEX, NERVE STIMULATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
P.F.C.
FDA UDI
DEPUY (IRELAND)·10603295215479·P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 1...
PFC SIGMA STB INS S1.5 12.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·June 20, 2019
PFC* MOD PLUS TIB TRAY SZ 1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·June 20, 2019
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860126180·Standard Band, Tooth 15-14/24-25, Size 26/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860126000·Standard Band, Tooth 15-14/24-25, Size 26
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860126220·Standard Band, Tooth 15-14/24-25, Size 26/Roth 22
AIRO Computed Tomography (CT) X-ray System
FDA 510(k)
FDA Class 2
·Radiology
ABSOANCHOR MICROIMPLANT
FDA 510(k)
FDA Class 2
·Dental
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·June 10, 2014
LINOX SMART PROMRI S 65
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·November 29, 2012
PRIMA ESTH CON ZI ABUT RD 5.0X1.5
FDA Adverse Event
Malfunction
·KEYSTONE DENTAL·Product code NHA·September 21, 2010
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012