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

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Penumbra System Penumbra JET 7X

FDA 510(k)
FDA Class 2 ·Cardiovascular

Oticon

FDA UDI
Oticon A/S·05707131339973·SIYA 2, KIT 312 2.4G NFM R C001

VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX

FDA 510(k)
FDA Class 2 ·Orthopedic

VIDAS TOXO IGG AVIDITY

FDA 510(k)
FDA Class 2 ·Microbiology

IDENTITY XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code LWP·January 13, 2014

APOLLO

FDA Adverse Event
Malfunction ·DRAEGER MEDICAL GMBH·Product code BSZ·August 1, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013

BD KIESTRA IDENTIFA

FDA Adverse Event
Malfunction ·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

PENTAX

FDA Adverse Event
Injury ·PENTAX·Product code EOQ·January 10, 2017

Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.

FDA Enforcement
Class II ·Terminated·Cook Inc.·March 8, 2017