14 results · 20ms · Sources: EU EUDAMED, 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