18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Veuron-Brain-pAb2
FDA 510(k)
FDA Class 2
·Radiology
RIGIDFIX
FDA UDI
DEPUY MITEK, LLC·10886705003143·RIGIDFIX TIBIAL ST GUIDE BLOCK
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114308·SINSKEY IOL HOOK ANG (BX/3)
SCANLAN® V.I.P™ Instrument Sterilization Trays
FDA UDI
SCANLAN INTERNATIONAL INC·00846159018592·Metal Sterilization Tray silver-grey color
CADD
FDA UDI
ICU MEDICAL, INC.·10610586016998·
CADD
FDA UDI
ICU MEDICAL, INC.·00610586016977·
CADD
FDA UDI
ICU MEDICAL, INC.·10610586016981·
ADVIA Centaur® Cuvettes
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414221588·Laboratory analyser cuvette, IVD
ULTRASAFE DENTAL INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
VPAP ADAPT
FDA 510(k)
FDA Class 2
·Anesthesiology
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 28, 2008
REMB MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·August 4, 2011
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·July 9, 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
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
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021