18 results · 22ms · Sources: EU EUDAMED, 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