18 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LOBSTER AUTO-INJECTOR
FDA 510(k)
FDA Class 2
·General Hospital
CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 26mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665033564·
Atoll™
FDA UDI
Seaspine Orthopedics Corporation·10889981052560·4.0mm x 26mm Poly Screw Assm. The Atoll OCT Spi...
Sochi
FDA UDI
Altus Spine, LLC·00843210166674·Polyaxial Screw, 4.0mm x 26mm
UniTip Catheter
FDA UDI
Unisensor AG·07640172971369·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973233·
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
PERFORMER HT/ HANG&GO HT BASIC
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
CN LOCK SCREW, F THREAD, Ø4.0MM X 26MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code KTW·September 9, 2025
UNK
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code KTW·September 12, 2025
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·April 29, 2022
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·May 15, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 27, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 14, 2011
2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·October 29, 2015
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·April 8, 2015
HANG&GO HT BASIC
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code LGZ·May 15, 2017