15 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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Brainomix 360 e-Lung
FDA 510(k)
FDA Class 2
·Radiology
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272424111·Bone Graft Implant Syringe 4.5 mm Curved
RR - UP - Commuter Passenger - zlb
FDA UDI
Certified Safety Manufacturing, Inc.·00766588024110·RR - UP - Commuter Passenger - zlb
MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NKM·July 7, 2017
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 10, 2011
ECHELON 60 ENDOPATH STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code GDW·November 24, 2008
POWERGLIDE MIDLINE CATHETER 20G,. 8CM FULL INSERTION KIT
FDA Adverse Event
Injury
·C. R. BARD INC. (BASD)·Product code FOZ·July 18, 2013
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
TMC SPEEDMTP
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014