15 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CUROS TIP
FDA 510(k)
FDA Class 2
·General Hospital
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180159·Integra® Jarit® Ryder Needle Holder, 4-7/8", Ca...
CHS
FDA UDI
Smith & Nephew, Inc.·03596010062444·AMBI SUPRACONDYLAR PLATE 10 SLOT 204MM 90D
Q-STRESS ECHO BED
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOVITA PEEK SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 30, 2013
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code DQX·August 31, 2021
PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBH·August 29, 2016
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013
DEPUY1 GENTAMICIN CEMENT 40G
FDA Adverse Event
Injury
·DEPUY CMW 9610921·Product code LOD·September 26, 2014
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 31, 2011
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018