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