16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SEDAT MYSHELL LITE
FDA 510(k)
FDA Class 2
·Cardiovascular
Pads
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761969056·Pad upper back section G
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761976108·Trumpf Medical/Medizin Pad upper back section G
Regent
FDA UDI
SPINAL ELEMENTS·00840916115036·Regent ACP 4-Level, 72mm
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014600116·30" SCHURE SPINE FRAME PAD
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606194·Schure Spine Frame Pads
POSI-LINK
FDA 510(k)
FDA Class 2
·General Hospital
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
FDA 510(k)
FDA Class 2
·Radiology
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 26, 2013
HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·April 22, 2011
PUMP MMT-722LCAS PRDGM INS SK EN LN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·July 21, 2008
BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 2, 2023
BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 2, 2023
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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