45 results · 22ms · Sources: EU EUDAMED, 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