11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Babyleo TN500
FDA 510(k)
FDA Class 2
·General Hospital
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575392247·Femoral Component,intracondylar, with patellar ...
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575392230·Femoral Component,intracondylar, with patellar ...
U-CLIP DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISCOVRED
FDA 510(k)
FDA Class 2
·Dental
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 13, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·January 25, 2022
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026
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