18 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVO Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331184123·Tenzel Bipolar Forceps, w/ stop, 0.5 mm tip, cu...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198925·AK3 Congruent Insert Trial Size 1, 14mm
Sklar®
FDA UDI
SKLAR CORPORATION·10649111125218·DRESSING FORCEP SERR 14"
LinkBio Instrument
FDA UDI
Link Bio Corp·00810022402955·Guide Rod, Tibial Cone D14/L80
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107576·TRIAL 90-SRK-191114 POLY-MPCS 1X14 RIGHT
ADVANCIS ACTIVON TUBE
FDA 510(k)
FDA Unclassified
·Unknown
TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL
FDA 510(k)
FDA Class 2
·Radiology
SURESIGNS VS2+ NBP/SPO2/WIRELESS
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MHX·August 26, 2021
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·November 12, 2020
M AF811 MASK
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 8, 2024
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 4, 2011
PROLENE* POLYPROP.MESH
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·June 26, 2013
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 26, 2008
FUSION COMPACT
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code PGW·November 30, 2020
WRIST SERIES 600 BLOOD PRESSURE MONITOR
FDA Adverse Event
Malfunction
·UNK·Product code DXN·March 17, 2026
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·Product code BTT·July 29, 2020
FUSION COMPACT
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code PGW·March 2, 2026