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