12 results · 20ms · Sources: EU EUDAMED, US FDA

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PHT-6500; PHT-60CFO; PAX-I3D

FDA 510(k)
FDA Class 2 ·Radiology

ZAVATION

FDA UDI
Zavation LLC·00842166186774·12mm X 26mm 6° Trial

AVS ANCHOR-C CERVICAL CAGE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ACTIVATOR V-E

FDA 510(k)
FDA Unclassified ·Unknown

LIFEPAK(R) 1000 DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015

LIFEPAK® 1000 DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·April 24, 2019

RSP SHOULDER

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code KWS·May 15, 2013

CONSULTA CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011

AFFINITY 4

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code HDD·August 20, 2008

TriVex 100SV Resector Kit, 4.5 Part Number: 7205876

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code GEI·June 19, 2006

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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

Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020