10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
WOM HYSTEROFLATOR OP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962159309·TROCAR SHARP FOR 3.2MM OPERATING SHEATH, COLOR ...
SIGN IM NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
GUAVA II
FDA 510(k)
FDA Class 2
·Cardiovascular
DRILL, AO, STERILE T2 FEMUR 4,2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HTW·December 18, 2012
UNKNOWN REJUVENATE STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LZO·January 15, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026
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