17 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LIFEDOP MODEL, L350R
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776364236·Oral Lower Anterior Molar
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036029975·
SYNTHES (USA) MIDFACE DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
ADVANTA SUPER SOFT GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014
TRUE BALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 16, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·January 22, 2015
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 2, 2013
ECHELON LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 15, 2014
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·April 26, 2011
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025