19 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
LOGIC FEMORAL PS POR RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 10, 2025
LOGIC CR FEMORAL POR, LEFT, SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 26, 2023
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699540·GENUMEDI PSS BLUE SIZE II
CoRoent
FDA UDI
Nuvasive, Inc.·00887517637345·CoRoent Ant TLIF PEEK, 14x10x30mm 12°
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
ADSON TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896076419·ADSON TISSUE FORCEPS WITH TUNGSTEN CARBIDE DUST...
MEDLINE PVC URETHRAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERSAPOINT RESECTOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AS LVP 20D 2SS CV
FDA Adverse Event
Injury
·Product code FPA·August 16, 2021
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC·Product code FRN·July 31, 2024
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC·Product code FRN·August 1, 2024
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWA·October 3, 2014
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·May 31, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 15, 2011
BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 30, 2020
LCP DIST-FEMPL4.5/5 R 17HO L396 SST
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·December 18, 2019
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024