12 results · 21ms · Sources: EU EUDAMED, US FDA

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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