16 results · 26ms · Sources: EU EUDAMED, US FDA

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MEGA 5.5 SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

JET DENTURE REPAIR

FDA UDI
LANG DENTAL MANUFACTURING CO., INC.·D6501234760·FAST CURING DENTURE REPAIR ACRYLIC RESIN POWDER...

BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX

FDA 510(k)
FDA Class 2 ·Radiology

UNIPACS WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

TRIATHLON P/A CR BEADED #5L

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·January 29, 2024

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code MCM·May 22, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

CAPSURE SP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011

TRIATHION

FDA Adverse Event
Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

TRIATHION COMPONENT

FDA Adverse Event
Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·December 22, 2020

1.55MM X 10MM FLUTED TWIST DRL

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016

1.55MM X 10MM FLUTED TWIST DRL

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025