24 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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