14 results · 20ms · Sources: EU EUDAMED, US FDA

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TMINI Miniature Robotic System

FDA 510(k)
FDA Class 2 ·Neurology

OsteoMed

FDA UDI
OSTEOMED LLC·00845694023290·FPS 3.5mm 10mm Wedge Plate

MORELAND

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295123385·MORELAND REV INST TREPHINE REAMER 15.5mm 9 IN

OsteoMed

FDA UDI
OSTEOMED LLC·00845694078108·FPS 3.5/4.0 10mm Wedge Plate Sterile Qty 2

GUIDEWIRES

FDA 510(k)
FDA Class 2 ·Cardiovascular

Valeo C Spacer System, Valeo II C IBF Device

FDA 510(k)
FDA Class 2 ·Orthopedic

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 28, 2021

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

MATRIX2 STANDARD 360 SR COIL

FDA Adverse Event
Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code HCG·November 19, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

ACCU-CHEK ® SPIRIT

FDA Adverse Event
Malfunction ·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 23, 2013

INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·October 30, 2025

TRUE METRIX AIR

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·September 6, 2022

PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. 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. 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