15 results · 34ms · Sources: EU EUDAMED, US FDA

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GINGI-PLAIN CORDS & BRAIDS

FDA 510(k)
FDA Class 1 ·Dental

Mrk, Ocular

FDA UDI
KATENA PRODUCTS, INC.·00841668119952·Dell Swivel Toric Mark. W/Rotating Bezel

BoneCam

FDA UDI
MEDLINE INDUSTRIES, INC.·00818614021195·

DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET

FDA 510(k)
FDA Class 2 ·Hematology

VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

THE M-COR MODULAR HIP SYSTEMS

FDA Adverse Event
Malfunction ·MIPRO US, INC·Product code LPH·January 23, 2015

COMP RVRS SHLDR GLNSP STD 36MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·December 11, 2018

COMP PRIMARY STEM 12MM STD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBF·December 11, 2018

COMP RVS TRAY CO 44MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·December 11, 2018

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 15, 2014

VIRTUOSO DR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·August 17, 2010

COMP RVRS 25MM BSPLT HA+ADPTR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·December 11, 2018

EQUINOXE PRESERVE STEM 6MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code PHX·April 25, 2024

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024