14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO PROFLU+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702429350·E1/AG/SL-OT/NOP5-T-OH/BR
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094032956·PROPAQ LT CHARGING CRDLE PLUG TYPE I AU
Aspiracath
FDA UDI
COOK INCORPORATED·00827002172708·Aspiracath
DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
X-POSURE SYSTEM VERSION 2 RAD
FDA 510(k)
FDA Class 2
·Radiology
PEN NDL 32G 4MM 100BX 1200 USA
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 29, 2021
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 2, 2019
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·June 25, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 2, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 27, 2020
PEN NEEDLE 32G 4MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 26, 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