12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SHILEY FLEXTRA TRACHEOSTOMY TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
Hawkin Ambler Dilator
FDA UDI
MEDGYN PRODUCTS, INC.·M803030787·Hawkin Ambler Dilator 9-12 mm
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10887488420707·IV DRESSING TRAY
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
FDA 510(k)
FDA Class 2
·Cardiovascular
NEWTOM QR-DVT 9000
FDA 510(k)
FDA Class 2
·Radiology
ZYGOMATIC IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·April 27, 2026
ACCU-CHEK ® SMARTVIEW TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 2, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 4, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code LZG·April 17, 2008
BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 30, 2023
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 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