9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SMR PARAGON CHAIR TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581162300001·A-FIT® 1. MOLAR UPR RGT SZ 23
EXETER HIP SYSTEM WITH V40 TAPER
FDA 510(k)
FDA Class 2
·Orthopedic
I-ENDO DUAL
FDA 510(k)
FDA Class 1
·Dental
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVN·October 31, 2012
POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIPMENT CO.·Product code ITI·June 2, 2015
11.0MM TI HELICAL BLADE 90MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·March 21, 2016
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018