12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AMNIOLENS
FDA 510(k)
FDA Class 2
·Ophthalmic
SLIDE-ON®
FDA UDI
MEDTRONIC XOMED, INC.·20613994394631·SHEATH 032104 10PK TNE BX DIAGNOSTIC
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00811801034299·Curette, Cup, Right Angled Up, Straight, Size 4
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SILO
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HWC·March 28, 2013
ATTAIN OTW
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 28, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 18, 2008
AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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