16 results
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20ms
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Sources: EU EUDAMED, US FDA
MT-300 CASSETTE HOLDER
FDA 510(k)
FDA Class 2
·Radiology
Measuring Device
FDA UDI
ADLER ORTHO SPA·08050507139323·SICKLE-SHAPED MEASURING DEVICE
ReLine
FDA UDI
Nuvasive, Inc.·00195377072429·RELINE C Ti Rod, 3.5x600mm Straight
Obtura Spartan
FDA UDI
OBTURA SPARTAN ENDODONTICS·00816168020077·Spartan Scaling Tip #6
Mio®
FDA UDI
Unomedical A/S·05705244007338·Single use infusion set for subcutaneous infusi...
A&E Medical / Thorecon™ Tower Cable Plate Kit (inc. screws & cable)
FDA UDI
A & E MEDICAL CORPORATION·10841291107231·Tower Cable Plate Kit (inc. screws & cable)
A&E Medical / Thorecon™ Tower Cable Plate Kit (inc. screws & cable)
FDA UDI
A & E MEDICAL CORPORATION·10841291105671·Tower Cable Plate Kit (inc. screws & cable)
GN Otometrics A/S
FDA UDI
Natus Medical Denmark ApS·05713315000324·
QWIKCHECK-BEADS
FDA 510(k)
FDA Class 2
·Hematology
NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 29, 2010
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·January 28, 2013
SECUR-FIT SHELL FOR CERAMIC SIZE 46 JAPAN
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·July 17, 2014
O-ARM O2 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OWB·June 29, 2023
PKG, 5MM INSERT, RETENTION GRASPER, 33CM, P/N 0250080697 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
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015