30 results
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21ms
·
Sources: EU EUDAMED, US FDA
GNR TRAFFIC LIGHT PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
Alpen Carbides
FDA UDI
Dent4You AG·07630392906050·Alpen Carbides 1558-FG-1.20-4.10, 10 pcs
MEDLINE INDUSTRIES, INC.
FDA UDI
MEDLINE INDUSTRIES, INC.·10198459391118·PLASTICS PACK
Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436126257·Sterile TP Pivot Pro™ transperineal needle guid...
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
FDA 510(k)
FDA Class 2
·Microbiology
QUANTA DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013
S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER
FDA Adverse Event
Injury
·CONVATEC INC.·Product code EXE·August 19, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 20, 2011
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 6, 2021
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 29, 2020
EVOLUT PRO TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 29, 2020
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 29, 2020
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 29, 2020
SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTD·January 24, 2025
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·March 9, 2016
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; 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