14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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