21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VETA PERITONEAL DIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104561·PS3 Screw 10.5mm x 50mm
5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 26, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 2, 2015
IMPLANT, FIXATION DEVICE CONDYLAR PLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDP·February 23, 2017
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·June 9, 2017
GLOBALCARDIO
FDA 510(k)
FDA Class 2
·Cardiovascular
EBONY PTA .035 PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JDP·June 1, 2015
ENDOWRIST ONE
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·May 8, 2013
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·September 24, 2014
PFCSIG POSTLIP INSERT SZ3 8MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 20, 2011
ATTUNE POS FEM AUG SZ 4 8MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·April 22, 2025
ATTUN REV OFFST STM ADPTR 2MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·April 22, 2025
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 2, 2015
4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 3, 2015
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
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