31 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
COVERIS
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CS1020890·Trial, 13 x 18mm, 3° Lordotic, 5mm
SYMPHONY
FDA UDI
Medos International Sàrl·10705034527383·SYMPHONY OCT SYSTEM DUAL DIAMETER ROD TITANIUM ...
VARIANT
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1020890·Trial 30x38mm, 20° Lordotic, 17mm
2.9 Knotted Driver
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215165017·
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020890·SPIRA®-A Integrated,Trial, 30x42mm, 20° Lordoti...
SYMPHONY
FDA UDI
Medos International Sàrl·10705034527390·SYMPHONY OCT SYSTEM DUAL DIAMETER ROD TITANIUM ...
CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ROSETTA-LT/ROSETTA-RX
FDA 510(k)
FDA Class 2
·Cardiovascular
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970010·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970027·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172974018·UniTip High Resolution Catheter 10F
DYNAMIC DECA
FDA Adverse Event
Malfunction
·C.R. BARD INC. (BEP)·Product code DRF·April 23, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·May 18, 2011
EXTRACTOR RX RETRIEVAL BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·August 7, 2008
MICRUSPHERE XL 6MMX20CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·November 20, 2020
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024