12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
FLOCARE N
FDA 510(k)
FDA Class 1
·Anesthesiology
Brigade
FDA UDI
Nuvasive, Inc.·00887517453501·Brigade HL Trial, 4x34x24mm 15°
Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only Kit
FDA UDI
Hemagen Diagnostics, Inc.·G5229025011·For the detection and titration of HSV-1 IgG an...
36M - City of Gastonia - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588025018·36M - City of Gastonia - Metal
LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
Quantib Prostate
FDA 510(k)
FDA Class 2
·Radiology
K1025-01-EDT
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·6 devices
ACCU-CHEK ® ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code FPA·June 30, 2014
COULTER® LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·January 8, 2013
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code INK·November 12, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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