42 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
FDA 510(k)
FDA Class 2
·Neurology
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00142006300·CC-310
Olympus
FDA UDI
Gyrus ACMI, LLC·00821925047259·ES-IP iOR BWK Hamburg ER (no rack)
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482057483·Sterilization Tray 6" X 30" X 3 1/2"
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68120063000000·Curved Sounding Probe
MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Radiology
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962112656·STERILIZATION TRAY, 6"X30"X3 1/2"
NEW CORONA VIRUS NUCLEIC ACID DETECTION KIT
FDA Adverse Event
Malfunction
·PERKINELMER, INC.·Product code QJR·March 5, 2021
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NIM·January 22, 2007
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 22, 2008
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 18, 2008
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 22, 2008
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 1, 2013
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·May 10, 2018
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·June 29, 2018
MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30
FDA Enforcement
Class II
·Terminated·Sentinel CH SpA·October 2, 2019
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2019