12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
STYLET AND TRACHEAL LIGHTWAND (STL)
FDA 510(k)
FDA Class 1
·Anesthesiology
iNSitu Total Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127024986·Lateralized Liner Trial Size 42/44 x 28mm ID
DILATING TIP TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER
FDA Adverse Event
Injury
·Product code GCJ·June 20, 2006
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
RADREX-I, SW V4.00 MODEL DRAD-3000E
FDA 510(k)
FDA Class 2
·Radiology
STEPHENS DISPOSABLE HOOKS
FDA 510(k)
FDA Class 1
·Ophthalmic
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 18, 2013
SIGMA 300 DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·December 13, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 9, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015