24 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Blood Administration Set

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V

Accufit

FDA UDI
Ortho Organizers, Inc.·00190707185183·AccuFit™ Molar Band UL7 - 33.5

PMT CORPORATION - STEREOTACTIC

FDA UDI
PMT CORPORATION·00650551068297·BRW/CRW-sEEG KIT: 2103-36, 2103-95 (QTY 2), 210...

Radius Plate PROlock II

FDA UDI
I.T.S. GmbH·09120047296912·Radius Plate PROlock II, Wide, 5-Hole, Right

SLENDERTONE FLEX, MODEL, 512

FDA 510(k)
FDA Class 2 ·Physical Medicine

CERAMIC BRACKETS

FDA 510(k)
FDA Class 2 ·Dental

BD MICROLANCE¿ 3 NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·September 29, 2022

OPTI-FREE MULTI-ACTION SOLUTION

FDA Adverse Event
Injury ·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPN·August 9, 2011

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 29, 2014

COGNIS

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013

Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.

FDA Recall
Terminated ·Philips Medical Systems Inc·Product code KPS·January 23, 2003

XVWEB

FDA Adverse Event
Injury ·PLANET DDS·Product code LLZ·March 13, 2025

SECOND OPINION

FDA Adverse Event
Injury ·PEARL INC.·Product code MYN·March 13, 2025

BD 30GA 1/2IN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 10, 2021

BD MICROLANCE¿3 NEEDLES 30 G

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·June 3, 2022

BD MICROLANCE¿ 3 NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·July 15, 2022

BD MICROLANCE 3 HYPODERMIC NEEDLES 30GX0.5"

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·February 1, 2022

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

FDA Recall
Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026