11 results
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22ms
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Sources: EU EUDAMED, US FDA
EndoTool SubQ
FDA 510(k)
FDA Class 2
·Anesthesiology
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180523230·DIAGONAL CORNER DRILL GUIDE - THREAD IN, 18MM
BD SYRINGE 1ML 29GA 12.7MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 1, 2019
MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
FDA 510(k)
FDA Class 2
·General Hospital
AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-PUERTO RICO·Product code JDZ·June 3, 2013
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC.·Product code MIH·June 22, 2011
PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. 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
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022