20 results · 26ms · Sources: EU EUDAMED, US FDA

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DISPOSABLE INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

AED BIPOLAR FORCEPS, MODEL 13-1646

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR

FDA 510(k)
FDA Class 1 ·General Hospital

BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03

FDA 510(k)
FDA Class 2 ·Ophthalmic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

ENDURON NEUT 60 OR 72ODX28ID

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 1, 2014

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
UNKNOWN·Product code ITJ·May 29, 2013

CARELINK PROGRAM W/TELEMETRY C

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

AMISTEM H, HA COATED STEM SIZE 3 LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 18, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

FDA Enforcement
Class II ·Terminated·Amendia, Inc·December 28, 2016

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

FDA Enforcement
Class II ·Terminated·Senseonics, Inc.·November 6, 2019

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