17 results · 37ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SMALL BONE LOCKING PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ALLON 2001

FDA 510(k)
FDA Class 2 ·Cardiovascular

DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

INSERT-HANDLE F/A2FN

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code FZX·April 29, 2013

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 19, 2011

PROGRAMMING WAND

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·July 25, 2008

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020

UNFOLDER PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018

REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·January 29, 2019

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021

Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018