15 results · 30ms · Sources: EU EUDAMED, 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