14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K-Y BRAND LIQUIBEADS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Clement Clarke International
FDA UDI
CLEMENT CLARKE INTERNATIONAL LIMITED·05023323001085·ONE WAY VALVE INSPIRATORY (5X20)
ArgenZ HT+ 98x20 B3
FDA UDI
ARGEN CORPORATION, THE·D818122061·Dental porcelain/ceramic restoration kit
TREVAIR CHAIR ADULT
FDA 510(k)
FDA Class 1
·Physical Medicine
CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER
FDA 510(k)
FDA Class 2
·Cardiovascular
COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code MPB·February 13, 2017
INTELLAMAP ORION¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·May 21, 2013
PROLENE POLYPROPYLENE SUTURE
FDA Adverse Event
Death
·ETHICON INC.·Product code GAW·September 26, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·May 24, 2011
PEDICLE SCREW LATERAL CONNECTOR L150
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2023
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020