11 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517962539·Brigade Lateral Trial, 11x34x32mm 10°
CASTLE MODEL 233HC STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CONTOUR NEXT GEN
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 10, 2024
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·September 19, 2023
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·June 30, 2014
LCS COMPLETE M/B PAT POR LG
FDA Adverse Event
Injury
·WARSAW ORTHOPAEDICS·Product code NJL·January 9, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 19, 2010
Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Enforcement
Class II
·Terminated·TELEFLEX MEDICAL INC·August 5, 2020
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