14 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ULTRA SPHERICAL AMALGAM ALLOY

FDA 510(k)
FDA Class 2 ·Dental

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123175·K-WIRE - SINGLE TROCAR THREADED 1.8mm DIA x 150mm

TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR

FDA 510(k)
FDA Class 2 ·General Hospital

PremiPatch PTFE Pledget

FDA 510(k)
FDA Class 2 ·Cardiovascular

URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH A0396

FDA Adverse Event
Injury ·OLYMPUS WINTER & IBE GMBH·Product code FGB·December 16, 2016

HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Injury ·MEDTRONIC MILACA, INC.·Product code LWP·February 9, 2013

PUMP MMT-722LNAP PRDGM INS PL EN ML

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·December 30, 2010

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·UNKNOWN·Product code CAW·July 23, 2014

HF-RESECTION ELECTRODE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

HF-RESECTION ELECTRODE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

UNKNOWN

FDA Adverse Event
Injury ·OLYMPUS WINTER & IBE GMBH·Product code KNS·October 21, 2022

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025