22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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