45 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LITETOUCH MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517635419·CoRoent Ant TLIF PEEK, 10x10x28mm 15°
DRI pH-Detect 10.0 Control Kit
FDA UDI
Microgenics Corporation·00884883005532·
SleepWeaver Advance - Mask & Headgear - Leopard
FDA UDI
CIRCADIANCE, LLC·B036100285·SleepWeaver Advance Cloth Nasal CPAP Mask & Hea...
Plasti-Products
FDA UDI
PLASTI-PRODUCTS INC·10797876102859·sharps container, red vertical entry,8qt
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707054595·.016 UPPER NITANIUM® BIO KINETIX® UTILITY ARCHW...
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584511·Apex Tibial Nail Ø 10 x 285mm
CONTOUR PROFILE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SLEEP APP
FDA 510(k)
FDA Class 2
·Dental
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 12, 2026
WAVEWRITER ALPHA? PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 1, 2025
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 18, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 16, 2011
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·May 24, 2023
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 6, 2023
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 2, 2023
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015