28 results
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55ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Defender Safety Procedure Mask Level 1
FDA UDI
Defender Safety Inc.·00860007209505·The Defender Safety Procedure and Surgical Mask...
Defender Safety Surgical Mask Level 3
FDA UDI
Defender Safety Inc.·00860007209536·The Defender Safety Procedure and Surgical Mask...
Defender Safety Procedure Mask Level 3
FDA UDI
Defender Safety Inc.·00860007209529·The Defender Safety Procedure and Surgical Mask...
Defender Safety Procedure Mask Level 2
FDA UDI
Defender Safety Inc.·00860007209512·The Defender Safety Procedure and Surgical Mask...
ROSCOE
FDA Adverse Event
Injury
·DANYANG MAXTHAI MEDICAL EQUIPMENT CO., LTD.·Product code ITJ·July 6, 2023
OPD-SCAN III
FDA Adverse Event
Injury
·NIDEK CO. LTD.·Product code HKO·August 17, 2018
PROTON THERAPY
FDA Adverse Event
Injury
·OPTIVUS PROTON THERAPY·Product code LHN·December 26, 2014
Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany. The foot switches in the 1009.8 1 series are accessory components which can be connected to certain MAQUET operating tables. Several of the table top adjustment motions (depending on the table and foot switch versions in use) can then be executed by the foot. The foot switch is equipped with rocker switches. The switching elements are used to initiate the table top functions.
FDA Recall
Terminated
·MAQUET Inc.·Product code FWZ·December 8, 2008
HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.
FDA Recall
Terminated
·Hamilton Medical, Inc.·Product code CBK·September 26, 2013
Pediatric care bed; Product Designation: KayserBett IDA;
FDA Recall
Open, Classified
·KAYSERBETTEN GMBH & CO. KG Rieper Str. 12 Bad Fallingbostel Germany·Product code FNL·May 4, 2026
XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·June 9, 2011
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·March 4, 2015
DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit for Axio Observer that is used for microscopic analyses of dynamic processes within living cells. The DirectFRAP module is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The DirectFRAP Imaging System is a Class 3B laser system. The DirectFRAP Imaging System is a laser manipulation slider which allows coupling of laser light simultaneously with the conventional fluorescence illumination into the reflected-light beam path of the microscope system. Depending on the application, the laser light is used for the targeted bleaching of fluorophores for FRAP experiments or for the conversion of fluorophores within the cell.
FDA Recall
Terminated
·Zeiss, Carl Inc·Product code REK·April 28, 2011
SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·August 30, 2021
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·August 30, 2021
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·August 30, 2021
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·August 30, 2021
SOMATOM Force with software syngo.CT VB20 Model #10742326
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·August 30, 2021
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·August 30, 2021
SOMATOM Drive with software syngo.CT VB20 Model #10431700
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·August 30, 2021