16 results · 22ms · 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.

iLet® Dosing Decision Software

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ZEUS-P

FDA UDI
SPINAL ELEMENTS·00840916123031·Zeus-P Implant 16 x 9 x 22mm

PANDOR™ DeBakey Extra-Fine M-P Clamp 45° 37mm 16cm curved shanks

FDA UDI
Geister Medizintechnik GmbH·04057034058268·PANDOR™ DeBakey Extra-Fine M-P Clamp 45° 37...

ZEUS-P

FDA UDI
SPINAL ELEMENTS·00840916153540·Zeus PLIF, Curved Cage 22mm x 09mm x 16mm

Patient Administration Set

FDA 510(k)
FDA Class 2 ·Radiology

QFIX RADIOTHERAPY CHAIR

FDA 510(k)
FDA Class 2 ·Radiology

BD SYRINGE LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 30, 2019

MINIMED, NOVOLOG INSULIN

FDA Adverse Event
Death ·MEDTRONIC·Product code LZG·November 4, 2008

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 23, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 11, 2013

MEDLINE INDUSTRIES,LP

FDA Adverse Event
Malfunction ·ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD·Product code JKA·August 28, 2025

LIFE SCOPE PT

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023

LIFE SCOPE PT

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023

BD 1ML SYRINGE LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 11, 2019

SINGLE USE GUIDEWIRE

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code OCY·May 16, 2023

Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024