24 results · 35ms · Sources: EU EUDAMED, US FDA

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PIXI PEDIATRIC MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814671·GENUMEDI SILVER SIZE IV

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814213·GENUMEDI PT SILVER L IV

JOBST Bella Strong

FDA UDI
BSN MEDICAL, INC.·00035664008598·BELLA STRONG 15-20 MM HG ARMSLEEVE KNIT WELT SI...

Novo Surgical Inc.

FDA UDI
NOVO SURGICAL, INC.·00842331151972·probe w/ eye, usa pattern, stainless steel, 5" ...

CRYOPEN CRYOSURGICAL SYSTEM, K102214

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CK Reagent Kit

FDA UDI
MEDICA CORPORATION·00386100002183·Creatine-Kinase Reagent Kit for use with EasyRA...

MORRISON MEDICAL

FDA UDI
MORRISON MEDICAL, LTD·00647921102255·REUSABLE ARMBOARD,1X4,CS/24

SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

XPS 3000 SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

LINEAR? ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 8, 2025

IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015

CROSSROADS SCREW SYSTEM

FDA Adverse Event
Malfunction ·CROSSROADS EXTREMITY SYSTEMS·Product code HWC·September 29, 2022

SOLETRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 9, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

APEXPRO TELEMETRY SYSTEM

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code MHX·May 19, 2011

MICRODEBRIDER 1898200T IGS M4

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014

MICRA

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code PNJ·January 31, 2025

MICRA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code PNJ·January 31, 2025

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025