12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
FDA 510(k)
FDA Class 2
·Orthopedic
SCANLAN® V.I.P™ Instrument Sterilization Trays
FDA UDI
SCANLAN INTERNATIONAL INC·00846159008203·Metal Sterilization Tray silver-grey color
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
FLOWGUARD DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·August 4, 2011
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 22, 2008
INFINITY DENTAL IMPLANT SYSTEM
FDA Adverse Event
Injury
·ACE SURGICAL SUPPLY CO.·Product code DZE·July 3, 2013
NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)
FDA Adverse Event
Malfunction
·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023
MILAGRO ADVANCE SCREW 7X23MM
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·July 1, 2019
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