11 results
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26ms
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Sources: EU EUDAMED, US FDA
PERSONAL TRANSFER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
HemoStar XK Long-Term Hemodialysis Catheter
FDA UDI
Bard Access Systems, Inc.·00801741013676·HEMOSTAR XK HEMODIALYSIS CATH, ALPHACURVE, AIRG...
MSI-DIFF PLUS
FDA 510(k)
FDA Class 2
·Hematology
INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS
FDA 510(k)
FDA Class 2
·General Hospital
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·June 19, 2014
SOLETRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·October 25, 2010
DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3.BOX
FDA Adverse Event
APPLIED MEDICAL·Product code FZP·December 18, 2012
G7 DUAL MOBILITY LINER 44MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·August 12, 2020
FEMORAL HEAD 12/14 TAPER
FDA Adverse Event
Malfunction
·ZIMMER MANUFACTURING B.V.·Product code LPH·March 29, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021