16 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SI-BONE iFuse Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131281609·NERA2, BTE 13 WL 100 SIL
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100073·TEMPORAL SPECULUM SOLID BLADES
Bonding Accessories
FDA UDI
TP ORTHODONTICS INC·00192029043271·ADHESIVE, BRACKET-Tooth Conditioner, Resin
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS
FDA 510(k)
FDA Class 2
·Cardiovascular
CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01
FDA 510(k)
FDA Class 2
·Radiology
SYRINGE 50CC LL TIP CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·March 9, 2026
SYRINGE 50CC LL TIP CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·March 9, 2026
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 1, 2015
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
Malfunction
·DOLOMITE AB·Product code ITJ·October 8, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 6, 2013
TI CLICK'X LOCKING CAP FOR TI 3-D HEAD
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code NKB·June 24, 2011
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 21, 2015
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 21, 2015
MISAGO RX Self Expanding Peripheral Stem
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 7, 2016