13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MASTERmatic LUX
FDA 510(k)
FDA Class 1
·Dental
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613111953·Pennington Septum Elevator, Double Ended, 6 x 9...
SYNAPSE 3D CARDIAC TOOLS
FDA 510(k)
FDA Class 2
·Radiology
2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
FDA 510(k)
FDA Class 2
·Cardiovascular
BLUNT TIP SCREW, ÿ 4X46MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·April 28, 2025
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·October 6, 2014
2.5MM DRILL BIT/QC/GOLD/110MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HTW·June 3, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 29, 2011
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
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
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015