48 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LATITUDE ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE
FDA Adverse Event
Injury
·TORNIER INC·Product code JDC·May 7, 2024
PROFUNDA DEBAKEY CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921005620·PROFUNDA DEBAKEY CLAMP ANGLED CURVED JAW/SHANK ...
PROFUNDA DEBAKEY CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002623·PROFUNDA DEBAKEY CLAMP ANGLED CURVED JAW/SHANK ...
HS Diam. Burr, Ø4.0x70, 80k
FDA UDI
Bien-Air Surgery SA·17630055507034·
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552821·IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552811·IN-OVATION® C EURO 022 U5-5/L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532601·IN-OVATION® C Roncone 022/U5-5 L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532001·IN-OVATION® C Base Rx 022 U5-5/L3-3
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532611·IN-OVATION® C Roncone 022/U5-5 L3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532111·IN-OVATION® C Base Rx 022 U5-5/L3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532101·IN-OVATION® C Base Rx 022 U5-5/L3-3 CS HK
ALPHA DX SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFILTRATION KIT
FDA 510(k)
FDA Class 2
·Dental
PORTEX® PORTEX® ULTRAPERC® SINGLE DILATOR KIT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·February 22, 2019
PORTEX
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code JOH·September 25, 2020
TELAMON FUSION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 5, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 28, 2025
TELAMON® FUSION DEVICE
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·August 3, 2012
TELAMON® FUSION DEVICE
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·August 3, 2012