31 results · 22ms · Sources: EU EUDAMED, US FDA

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X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)

FDA 510(k)
FDA Class 2 ·Neurology

XENMATRIX

FDA UDI
Davol Inc.·00801741129001·XenMatrix AB Surgical Graft, 20 cm x 40 cm

OsteoMed

FDA UDI
OSTEOMED LLC·00842528127346·2.0 X 40mm Cannulated Headless Screw, T7

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741520400·

LACTOSORB* SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036054144·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674152040060·

PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

QUICKSMILE

FDA 510(k)
FDA Class 1 ·Dental

RADIFOCUS GLIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

PELVICOL ACELLULAR COLLAGEN MATRIX

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 29, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 8, 2014

OHICHO3

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·August 30, 2022

OHICHO3

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·March 18, 2026

METACROSS OTW PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·August 19, 2019

OHICHO NEO

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·February 7, 2024

OHICHO3

FDA Adverse Event
Injury ·Product code LIT·December 26, 2019

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 12, 2017

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·August 12, 2020

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 27, 2016