15 results · 29ms · Sources: EU EUDAMED, US FDA

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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