43 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
PowerPICC SOLO
FDA UDI
Bard Access Systems, Inc.·00801741147647·Catheter Placement Kit
APEX Spine System
FDA UDI
SPINECRAFT, LLC·00193082050701·Dual Purpose Derotator Handle
basixCOMPAK™
FDA UDI
Merit Medical Systems, Inc.·00884450021804·
FlowLogic Assert
FDA UDI
SONENDO, INC.·00810209421212·FlowLogic Assert Shaping File 25 Variable, 21mm
WALLSTENT BILIARY ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·January 10, 2019
CARDIOSAVE HYBRID, TYPE I PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·February 21, 2025
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·August 26, 2014
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·December 28, 2022
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·March 12, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 17, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·February 18, 2008
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·December 28, 2022
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·May 6, 2022
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·March 18, 2022
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·March 18, 2022
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022