12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ZAVATION IBF SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
2420 5 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00874750009527·2420A 5W STPCK 10.5/7.5MM
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEMA SCREEN ER
FDA 510(k)
FDA Class 2
·Hematology
NON-LOCKING DRILL GUIDE 3.5
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·May 10, 2023
GORE® ACUSEAL VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·February 3, 2025
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 26, 2011
HS ACE 14 CM SCISSOR HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 11, 2008
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·January 31, 2025
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025