11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814701·GENUMEDI SILVER SIZE VII
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227873·Wullstein House Cup Fcps, jaws cvd left
Rampart One Lumbar Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7404902207·Rampart One Oblique Trial, 14mm, M, 8°
MACROPOREPX PEDIATRIC SYSTEM
FDA 510(k)
FDA Class 2
·Dental
RESTORELLE POLYPROPYLENE MESH
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2014
DURALOC CONST LINER 54X32
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 15, 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