21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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