13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319700563·McGlamry Metatarsal Elevator 6-3/8" (16cm), bla...
WALLSTENT ENTERNAL PROSTHESIS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
FDA 510(k)
FDA Class 3
·Cardiovascular
LINEAR 7.5 FR. 25CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019
LINEAR 7.5 FR. 25CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019
CLINAC
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS, INC.·Product code IYE·April 3, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 18, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·May 8, 2008
LINEAR 7.5 FR. 40CC IAB
FDA Adverse Event
Injury
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 14, 2020
HUIBREGTSE NEEDLE KNIFE PAPILLOTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·July 19, 2022
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013