18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FreedomEdge Syringe Infusion System
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517298928·CoRoent® XL-XW, 14x26x45mm
HAWKEYE™ Vertebral Body Replacement (VBR)
FDA UDI
Choice Spine, LP·00840996101042·VBR,SPACER,12X14X45,0 DEG
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113898·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 M...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694020671·FPS 4.0mm x 45mm Standard Screw
Mediflex Modular III Basic Laparoscopic Instruments
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102103995·Modular 3 Babcock Forceps,Insert only,5mmx45cm
Mediflex Modular III Basic Laparoscopic Instruments
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102103988·Modular 3 Babcock Forceps,Ratcheted Handle/Sha...
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 18, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 18, 2023
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075008·FPS 4.0 x 45mm Screw Sterile Qty 2
FUSEFORCE IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACTIVA PRESTO PACK
FDA 510(k)
FDA Class 2
·Dental
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026
PUMP MMT-522WWL PRDGM INSULIN CL EN ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·October 23, 2008
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·August 2, 2011
INFINITY DENTAL IMPLANT SYSTEM
FDA Adverse Event
Injury
·ACE SURGICAL SUPPLY CO.·Product code DZE·July 3, 2013
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 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