16 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL LUNA MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
CARRIAZO PENDULAR
FDA 510(k)
FDA Class 1
·Ophthalmic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 11, 2025
FUJIFILM 600 SERIES ENDOSCOPE EC-600WM
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·January 22, 2025
STAIR PRO - MODEL 6252
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPP·May 29, 2013
COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·June 17, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 1, 2014
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 20, 2025
COMP LK SCR 3.5HEX 4.75X20 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·May 17, 2018
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 10, 2018
COMP NLK SCR 3.5HEX 4.75X15 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·May 17, 2018
COMP RVS CNTRL SCR 6.5X30MM ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 10, 2018
COMP LK SCR 3.5HEX 4.75X20 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·May 17, 2018
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿¿¿¿¿¿ 2089507-149; j)¿¿¿¿¿¿ 2089507-153; k)¿¿¿¿¿ 2089507-154; l)¿¿¿¿¿¿ 2089507-155; m)¿¿¿ 2089507-156; n)¿¿¿¿ 2089507-157; o)¿¿¿¿ K2037DAED; p)¿¿¿¿ K2037DBED; q)¿¿¿¿ K2037DED; r)¿¿¿¿¿ K2037DJED; s)¿¿¿¿¿ K2037DNED; t)¿¿¿¿¿ K2042TTED; u)¿¿¿¿ K2049DC; v)¿¿¿¿¿ K2049DD; w)¿¿¿ K2049DF; x)¿¿¿¿¿ P2037DAED; y)¿¿¿¿¿ P2037DBED; z)¿¿¿¿¿ P2037DED; aa)¿¿ To be provided
FDA Enforcement
Class II
·Ongoing·GE Healthcare·October 16, 2024
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018