17 results · 24ms · Sources: EU EUDAMED, US FDA

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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