16 results · 29ms · Sources: EU EUDAMED, US FDA

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BriefCase-Quantification

FDA 510(k)
FDA Class 2 ·Radiology

LEONE SPA

FDA UDI
LEONE SPA·08033707061489·BRACKETS 22 T+5 A+10 LAT U/L

Portex

FDA UDI
ICU MEDICAL, INC.·15019517072624·

MORELAND

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295123026·MORELAND REV INST EXTRACTION HOOK

Atricure Cryo Module System; cryoICE cryoablation probe

FDA 510(k)
FDA Class 2 ·Neurology

LEONARDO SYNGO CARDIOLOGY WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

PURE PECTUS

FDA UDI
KLS-Martin L.P.·00888118142337·PULLOUT TRAY, INSTRUMENTS 1

PURE PECTUS

FDA UDI
KLS-Martin L.P.·00888118142320·LID, CASE, INSTRUMENTS

PURE PECTUS

FDA UDI
KLS-Martin L.P.·00888118142313·CASE, FOR INSTRUMENTS

PURE PECTUS

FDA UDI
KLS-Martin L.P.·00888118142344·PULLOUT TRAY, INSTRUMENTS 2

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

BIO-COMP INTERFSCRW W/DISP SHTH

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code MAI·October 3, 2025

MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·November 24, 2008

INTERMATE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 9, 2011

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 23, 2013

Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026