16 results · 35ms · Sources: EU EUDAMED, 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