18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AViTA Pulse Oximeter (SP62B)
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613029821·Westcott Type Stitch Scissors, Sharp Tips, 20mm...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613073732·Westcott Conjunctival Scissors, Lightly Curved,...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613073718·Westcott Tenotomy Scissors, Curved, Right, 1 " ...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613073725·Westcott Utility Scissors, Curved (7 Degrees +-...
Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
FDA 510(k)
FDA Class 2
·Radiology
DEVILBISS NASAL CPAP MASK, 9354 SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
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
CURRENT RF DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2011
S-ROM M HEAD 36MM +6
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code LPH·November 11, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 23, 2013
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
OT SURESTEP METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 6, 2010
TMC SPEEDMTP
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025
PKG, 5MM INSERT, PADDLE BABCOCK, 45CM, P/N 0250080727 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
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 26, 2019