16 results · 21ms · Sources: EU EUDAMED, US FDA

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BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776402808·Plester Helms Retractor, 11cm, 2 prongs on Righ...

n.a.

FDA UDI
Karl Storz GmbH & Co. KG·04048551074091·PLESTER-HELMS Retractor, 11cm

Bailey Aortic Clamp angled 21cm 30x8 shanks curved

FDA UDI
Geister Medizintechnik GmbH·04057034055847·Bailey Aortic Clamp angled 21cm 30x8 shanks...

Diafil & Diafil Capsule

FDA 510(k)
FDA Class 2 ·Dental

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

FDA 510(k)
FDA Class 2 ·General Hospital

HERBAL PAD

FDA Adverse Event
Injury ·SHUXIAO INDUSTRY CO.,LTD·Product code HHL·February 23, 2023

SYNCHROMED EL

FDA Adverse Event
Injury ·RICE CREEK MANUFACTURING·Product code LKK·November 4, 2008

ANIMAS INSULIN INFUSION PUMP

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

OT VERIO TEST STRIPS

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

FDA Enforcement
Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth

FDA Enforcement
Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020