45 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
COOLEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921005210·COOLEY BULLDOG CLAMP RING HANDLE CURVED JAW CUR...
Tru-Arch Ni-Ti
FDA UDI
ORMCO CORPORATION·00889989027167·NITI CR TRU-ARCH 16x22 UPR MED-BP/100
DAVIS GALL STONE SCOOP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896091443·DAVIS GALLSTONE SCOOP DOUBLE ENDED BLUNT TIP
HS Diam. Burr, Ø3.5x70, 50k
FDA UDI
Bien-Air Surgery SA·07630055506627·
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531101·IN-OVATION® C Base Rx 018 U5-5/L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531601·IN-OVATION® C Roncone 018 U5-5/L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531111·IN-OVATION® C Base Rx 018 U5-5/L3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531001·IN-OVATION® C Base Rx 018 U5-5/L3-3
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531611·IN-OVATION® C Roncone 018 U5-5/L3-3 CS-BC HK
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551921·In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551821·IN-OVATION® C EURO 018 U5-5/L3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551811·IN-OVATION® C EURO 018 U5-5/L3-3 CS HK
KEYSTONE HIP
FDA 510(k)
FDA Class 2
·Orthopedic
NICOLET VERSALAB
FDA 510(k)
FDA Class 2
·Radiology
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 29, 2025
NAVLOCK TRACKER UNIVERSAL GREY
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code OLO·December 21, 2015
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
TERUMO CDI 100 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTY·May 13, 2011