12 results
·
24ms
·
Sources: EU EUDAMED, US FDA
CARBAMAZEPINE EIA TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192084·Apex Revision Knee Reamer - Zimmer 10mm
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106891·SINSKEY TYING FORCEPS STRAIGHT
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955937439·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939778·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938603·Percutaneous Transluminal Angioplasty Balloon C...
S.L.T. CONTACT LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
FDA 510(k)
FDA Class 2
·Cardiovascular
CORDLESS DRIVER 2 HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·February 11, 2013
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
PARIETEX UGYTEX PP 15X10CM X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·July 22, 2014
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