23 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ECG Monitor App
FDA 510(k)
FDA Class 2
·Cardiovascular
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433880·Integra® Jarit® Kelly Retractor, 10-1/2", Hollo...
24M - Nevada Energy - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114001·CHANG HYDRO-DISSECT CANNULA 27GA
LIPOSUCTION CANNULA
FDA UDI
SONTEC INSTRUMENTS, INC.·B0992011680·LIPOSUCTION CANNULA COBRA
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306821509·Halpern Breast Caliper, 38mm
LEGEND POWER ADAPTER MODEL: 6475000
FDA 510(k)
FDA Class 2
·Neurology
JUMP START, MODEL 970300
FDA 510(k)
FDA Class 3
·Cardiovascular
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·October 31, 2018
NUROLON NYLON SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·October 31, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·July 3, 2020
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300
FDA Enforcement
Class II
·Terminated·Anodyne Surgical·June 23, 2021
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
HICKMAN
FDA Adverse Event
Malfunction
·C.R. BARD, INC.·Product code LJS·April 8, 2013
T-LINK DATA MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·July 29, 2011
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300
FDA Recall
Terminated
·Anodyne Surgical·Product code HMX·April 21, 2021
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020