13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
ENDOSCOPIC CLIP SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LITHOGOLD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OSSIX BONE, OSSIX PLUS
FDA Adverse Event
Injury
·DATUM DENTAL LTD.·Product code NPM·June 22, 2022
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 11, 2013
POLYFLUX L CAPILLARY DIALYZER
FDA Adverse Event
Injury
·GAMBRO DIALYSATOREN GMBH·Product code KDI·July 12, 2011
SURESCAN
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code LGW·October 10, 2014
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
EXCEL 23KHZ STANDARDTIP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·November 3, 2016
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026