19 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Kingon P2 Oxygen Concentrator
FDA 510(k)
FDA Class 2
·Anesthesiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517567963·CoRoent Ant TLIF PEEK, 9x10x30mm 4°
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699564·GENUMEDI PSS BLUE, SIZE IV
Orthos
FDA UDI
ORMCO CORPORATION·00889989029871·ORTHOS CM CUNITI 27ARCH 18DIALOLGPK10
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189374·AK3 Femoral Distal Locating Device, 4° Bushing
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804625·Converse Nasal Retractor, 16mm x 10mm Blade, 9cm
ST AIA PACK HBA1C
FDA 510(k)
FDA Class 2
·Hematology
WAVEON WRX BONE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·October 6, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE ? SINGAPORE·Product code FRN·August 4, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 26, 2013
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 20, 2015
STEALTHSTATION S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·December 8, 2020
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·May 20, 2025
STEALTHSTATION S8 PREMIUM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·October 15, 2019
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·May 6, 2015
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026