14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K133551621·ELATION® MB Base Rx 018 UL/5-5 CS-BC HK
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189551921·In-Ovation R RNC/BASE/EURO 018 UL5-5 CS-BC HK
IN-OVATION® R
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K18955183U1·IN-OVATION® R EURO 018 U5-5 CS-1BC HK
IN-OVATION® R
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K18955183L1·IN-OVATION® R EURO 018 L5-5 CS-1BC HK
IN-OVATION® R
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189551821·IN-OVATION® R EURO 018 UL/5-5 CS-BC HK
ESOPHAGEAL TTS STENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 18, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 29, 2011
MIDAS REX MR8
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025
MOTOR MR8 ELECTRIC
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022