17 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
s-Clean OneQ-SL Narrow Implant System
FDA 510(k)
FDA Class 2
·Dental
Ceramco® II Silver™
FDA UDI
Dentsply International Inc.·D0011612440·
SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
FDA 510(k)
FDA Class 2
·General Hospital
MUCOGRAFT
FDA 510(k)
FDA Class 2
·Dental
ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEXALOBE, 26MM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, INC·Product code HWC·June 22, 2018
TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·January 18, 2017
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWP·October 10, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 11, 2008
TURBO-JECT POWER INJECTABLE
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·July 3, 2018
ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEXALOBE, 26MM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, CORP·Product code HWC·June 22, 2018
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·August 24, 2017
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·April 17, 2023
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
1820334-2020-01805
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 5, 2020
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·June 28, 2018
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; 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