22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill
FDA 510(k)
FDA Class 2
·Orthopedic
Cut Guide
FDA UDI
Treace Medical Concepts, Inc.·00810111222662·Single Slot Cut Guide
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113950·JOHN INTRALASIK CANNULA 27GA
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151801·IN-OVATION® C EURO 018 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151101·IN-OVATION® C Base Rx 018 UP5-5 CHK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151111·IN-OVATION® C Base Rx 018 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151811·IN-OVATION® C EURO 018 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151001·IN-OVATION® C Base Rx 018 U5-5
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK
UD-1000 ULTRASONIC A/B SCANNER
FDA 510(k)
FDA Class 2
·Radiology
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
FDA 510(k)
FDA Class 2
·Ophthalmic
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 21, 2014
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·August 10, 2011
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·July 1, 2013
API® 20E TEST STRIP
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JSS·March 16, 2018
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024
MECTALIF TRANSFORAMINAL CAGES TIPEEK
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025