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

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HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX

FDA 510(k)
FDA Unclassified ·Unknown

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213036321·Coupling Treatment Tube for 6F Flexibles (28)

Rhythmlink®

FDA UDI
RHYTHMLINK INTERNATIONAL, LLC·00816312024685·25 Monopolar Needle Electrodes, EMG, 75mm x 25g

Chalgren

FDA UDI
CHALGREN ENTERPRISES·00816020020085·Monopolar Needle Electrode, EMG, 75mm x 25g

22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010

FDA 510(k)
FDA Class 2 ·Orthopedic

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·August 5, 2019

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·September 6, 2019

CADD SOLIS VIP PUMPS

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022

MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·February 5, 2019

GREENLIGHT HPS BPH FIBER OPTIC

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 6, 2013

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·September 23, 2014

UNKNOWN DEPUY 28 +1.5 HEAD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 13, 2011

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022

MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·July 7, 2025

PREMILENE 3/0 (2) 75CM DS24 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAW·December 11, 2019

MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012