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

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Permanent Sled Bag

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768475·GENUMEDI PSS GREEN III

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100370·COOK EYE SPECULUM #3 SOLID

STINGRAY LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

CORONIS 2MP-21 AND MFGD 2621

FDA 510(k)
FDA Class 2 ·Radiology

SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

SYRINGE 30ML LL S/C 56

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·November 13, 2024

CLICK

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 24, 2025

STINGRAY? LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

FDA Adverse Event
Injury ·MPRI·Product code NVN·June 7, 2013

VASOVIEW HEMOPRO EVH SYSTEM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·June 24, 2011

GE OEC STENOSCOPE

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 10, 2008

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024