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

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INOMAX DSIR (DELIVERY SYSTEM)

FDA 510(k)
FDA Class 2 ·Anesthesiology

ArgenIS

FDA UDI
ARGEN CORPORATION, THE·D818131686·TiBase MS NP .8G E

3.5MM CORTEX SCREW SELF-TAPPING 55MM

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HWC·January 26, 2017

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·July 25, 2018

FDR IMAGE STITCHING OPTION

FDA 510(k)
FDA Class 2 ·Radiology

AEROMIST LT, MODEL HCS15004

FDA 510(k)
FDA Class 2 ·Anesthesiology

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·November 18, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

3.5MM CORTEX SCREW SELF-TAPPING 16MM

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·January 6, 2016

3.5MM CORTEX SCREW SELF-TAPPING 14MM

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·January 6, 2016

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code DTB·October 1, 2014

BONE HOLDING FORCEPS SELF-CENTER SOFTLO

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HTD·May 29, 2013

CARELINK PROGRAM W/TELEMETRY C

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code DXY·June 16, 2011

CORTSCR 3.5 SELF-TAP L65 TI

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code HWC·April 29, 2013

3.5MM CORTEX SCREW SELF-TAPPING 22MM

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·December 21, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·January 4, 2016

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·July 14, 2016

3.5MM TI CORTEX SCREW 36MM

FDA Adverse Event
Malfunction ·SYNTHES TRAUMA : OBERDORF : SYNTHES PRODUKTIONS GM·Product code HWC·February 9, 2018

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015