10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CARDS Q.S. STREP A
FDA 510(k)
FDA Class 1
·Microbiology
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221117496·3M™ Victory Series™ Second Molar Bands, 955-108...
Zuma
FDA UDI
Seaspine Orthopedics Corporation·10889981120610·Slap Hammer Connector
RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CONTORNO(R), MODELS E AND ST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
24MM COCR RADIAL HEAD
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·March 13, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 11, 2013
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
EZ STEER? NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·July 24, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021