9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADAMS A1c HA-8180V, CALIBRATOR 80
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMPLANT-ONE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN POLY BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
PROTECTA XT DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2025
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·January 25, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022