14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
FDA 510(k)
FDA Class 2
·Cardiovascular
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
ELMED
FDA UDI
ELMED INCORPORATED·00842180134942·ELMED REUSABLE MONOPOLAR ELECTRODES - LOOP ELEC...
Bright Tray
FDA UDI
ORMCO CORPORATION·00889989059731·BRIGHT TRAY-UPPER-SIZE 12-PINK-PK 20
Easytech Anatomical Shoulder System
FDA UDI
FX SOLUTIONS·03701037313732·EASYTECH ANCHOR BASE TA6V Ø42 mm CEMENTLESS Ti/HA
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704479·Crile Hemostatic Forceps 5-1/2" (13.8cm), straight
DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDISIL SILICONE SHEETING
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2024
ENDOTAK RELIANCE SG
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·October 3, 2014
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL - FLARSHEIM CO.·Product code IXR·May 29, 2013
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·June 25, 2011
CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·July 22, 2020
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013