9 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELMED
FDA UDI
ELMED INCORPORATED·00842180148406·PCL RETRACTORS, STANDARD, OVERALL LENGTH: 9.875...
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
FDA 510(k)
FDA Class 2
·Orthopedic
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·November 6, 2014
DEPUY ASR XL FEM IMP SIZE 39
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·August 18, 2011
IMPLANT PDS3000M 6PK PILLAR PALATAL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code LRK·July 18, 2013
SMALLBORE EXT SET
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·July 6, 2016
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020