23 results
·
23ms
·
Sources: EU EUDAMED, US FDA
RxSight Insertion Device
FDA 510(k)
FDA Class 1
·Ophthalmic
ZenFlex
FDA UDI
Kerr Corporation·00195062029684·Rotary Files
Lateral Patient Positioning System
FDA UDI
ALPHATEC SPINE, INC.·00190376484228·Head Board Pad
Origin
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001513·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111814010·Origin Hip Stem, Lateralized High Offset Collar...
N/A
FDA UDI
Ortho Development Corporation·00822409129850·Extramedullary Tibial Cut Guide, Left
Paxeon Origin
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200559·Origin Stem, High Offset Size 14
Origin Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051594·
NEUMOVENT GRAPHNET MODEL 3179L1V
FDA 510(k)
FDA Class 2
·Anesthesiology
MAYFIELD MR/X-RAY SKULL CLAMP
FDA 510(k)
FDA Class 2
·Neurology
BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·September 29, 2022
CABLE,ECG LEAD,OR,5L,AAMI
FDA UDI
Datascope Corp.·10607567112251·CABLE,ECG LEAD,OR,5L,AAMI
STRATUS Stem
FDA UDI
AMPLITUDE SAS·03701089521383·
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·July 25, 2023
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·July 22, 2022
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 17, 2014
WALLFLEX? BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·June 21, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·July 21, 2011
BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·September 20, 2022
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023