22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1416550·14mm H x 16mm W x 55mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X14165580·14mm H x 16mm W x 55mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X141655120·14mm H x 16mm W x 55mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L141655120·14mm H x 16mm W x 55mm L XLIF Trial 12 degree L...
FLAATZ 760
FDA 510(k)
FDA Class 2
·Radiology
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
FDA 510(k)
FDA Class 2
·Dental
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065648·Corpectomy, 14Dx16Wx55H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065358·Corpectomy, 14Dx16Wx55H 0°
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2017
BD SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 19, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 3, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 4, 2019
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·June 27, 2011
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 4, 2014
BD AffirM VPIII Microbial Identification Test
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·March 8, 2017
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 24, 2019