15 results · 31ms · Sources: EU EUDAMED, 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