21 results · 23ms · Sources: EU EUDAMED, US FDA

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Integra TITAN Reverse Shoulder System

FDA 510(k)
FDA Class 2 ·Orthopedic

Expiratory valve set

FDA UDI
Hamilton Medical AG·07630002803199·Expiratory valve set for HAMILTON-C1/T1/MR1, ne...

STALIF C

FDA UDI
Centinel Spine, Inc.·00815101023885·

STALIF C-Ti

FDA UDI
Silony Medical Corp·00840402505532·STALIF C-Ti CAGE 3 Scr tap. 16 x 10.5

STALIF C-Ti

FDA UDI
Centinel Spine, Inc.·00815101028774·

STALIF C

FDA UDI
Centinel Spine, Inc.·00815101023953·

STALIF C

FDA UDI
Silony Medical Corp·00840402505501·STALIF C 3 Hole Domed Cage 16 X 10.5

STALIF C

FDA UDI
Silony Medical Corp·00840402505525·STALIF C 3 Hole Tapered Cage 16 X 10.5

STALIF C-Ti

FDA UDI
Centinel Spine, Inc.·00815101028989·

STALIF C-Ti

FDA UDI
Silony Medical Corp·00840402505518·STALIF C-Ti CAGE 3 Scr DOMED, 16 x 10.5

EXPIRATORY VALVE SET

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·October 19, 2023

DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

REAVILLMED PRESSURE MONITORING SYSTEM AND PICC

FDA 510(k)
FDA Class 2 ·Cardiovascular

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 30, 2023

EXPIRATORY VALVE SET

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code BYX·May 20, 2025

VITALITY 2

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 13, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

SYNERGY

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 15, 2008

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025