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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CO2mbiLED

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DJO SURGICAL

FDA UDI
Encore Medical, L.P.·00190446270041·Special, AltiVate Anatomic Cannulated Ream-Run ...

LIPOSUCTION CANNULA

FDA UDI
SONTEC INSTRUMENTS, INC.·B0992010960·LIPOSUCTION CANNULA WITH TWO HOLES CURVED

CHISEL

FDA UDI
The Wells Johnson Company·B458201096000·Cannula, Chisel, specify length, diameter and h...

BURR HOLE COVER, MODEL XX

FDA 510(k)
FDA Class 2 ·Neurology

X-SIZER CATHETER SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

PFC*SIGMA C/R NPOR FEM RT SZ 3

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 17, 2019

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 27, 2014

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 28, 2013

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 11, 2011

INJECTOR LOCKING N40-O

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 15, 2022

BD PHASEAL OPTIMA INJECTOR (N40-O)

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021

INJECTOR LOCKING N40-O

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 21, 2021

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021