16 results · 23ms · Sources: EU EUDAMED, US FDA

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JOINT STIM, MODEL 1000

FDA 510(k)
FDA Class 2 ·Neurology

NXSTAGE PUREFLOW SOLUTION

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64

FDA 510(k)
FDA Class 2 ·Radiology

FR CLERMONT FERRAND

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·October 3, 2012

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 25, 2025

MERCY HSP PITTSBURGH PA 1

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DWE·May 7, 2009

HCSG/HENDRICK MED/ABLNE TX 1

FDA Adverse Event
Malfunction ·SORIN GROUP USA, INC.·Product code DWE·February 16, 2010

DIDECO COMPACTFLO EVO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·January 16, 2013

DIDECO COMPACTFLO EVO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code KFM·December 13, 2012

DIDECO COMPACTFLO EVO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·October 18, 2012

PROLIFT PELVIC FLOOR REPAIR

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTP·April 23, 2013

AU681-02E CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 1, 2011

IDENTITY DR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008

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

Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012