12 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TRABECULO-SUPRACHOROIDAL SHUNT
FDA 510(k)
FDA Class 2
·Ophthalmic
TITAN PLUG SCREW 8MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA GMBH·Product code HSB·February 21, 2002
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER FREE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 8, 2013
TX1 TISSUE REMOVAL SYS - MICROTIP
FDA Adverse Event
Malfunction
·AMERICAN OPTISURGICAL, INC.·Product code LFL·February 24, 2014
RX ACCUNET EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NTE·November 11, 2010
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
DYNASTY® A-CLASS® STD POLY LINER 36MM GROUP E
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code JDI·December 10, 2025
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
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