10 results · 21ms · Sources: EU EUDAMED, US FDA

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CapsoCam Plus (SV-3) Capsule Endoscopy System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BD INSULIN SYRINGE 0.3ML, 31G X 8MM

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·November 8, 2017

Stabilynx PEEK Suture Anchor

FDA 510(k)
FDA Class 2 ·Orthopedic

VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II

FDA 510(k)
FDA Class 2 ·Immunology

BD INSULIN SYRINGE 0.3ML, 31G X 8MM

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 16, 2017

ASR ACETABULAR CUPS 48

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·November 20, 2008

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·July 23, 2013

MEDTRONIC TRANSCATHETER VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 20, 2022

PKG, ALLIS DOUBLE ROW TEETH, P/N 0250080592 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