15 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline Hemo-Force DVT Compression Sleeve
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486003425·MCK PATELLOFEMORAL TRIAL (5 RIGHT)
Denovo Preformed Matrix Band
FDA UDI
Denovo Dental, Inc.·00810059291119·Denovo Preformed Matrix Band - Adult 1/4, Size 15
SIGNATURE PLANNER / SIGNATURE GUIDES
FDA 510(k)
FDA Class 2
·Orthopedic
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026
GRIPPER MICRO SAFETY NEEDLE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code FPA·May 24, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 20, 2011
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 14, 2014
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026
BD¿ BLUNT FILL NEEDLE 18G X 1.5 IN.
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·August 31, 2017
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025
TERUMO RADIFOCUS GUIDE WIRE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026