16 results
·
27ms
·
Sources: EU EUDAMED, US FDA
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
FDA 510(k)
FDA Class 2
·Cardiovascular
PDS PLATES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
STERILMED, INC.·10888551007580·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007573·SAW BLADE SAGITTAL FLARED K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007559·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007566·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007603·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007597·SAW BLADE SAGITTAL K9 K2000 SERIES
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 30, 2014
CURRENT PLUS DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 8, 2013
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC·Product code NQO·November 17, 2010
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 3, 2017
UNIV 2-HOLE SHL 52MM LNR SZ 23
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 15, 2018
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