16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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