12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
VISTEK ELECTRONIC CONTROLLER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925023239·PIST SCHUK TEF/WIRE .4 MM
ORA Implant Abutment 3.0mm Cuff (AY)
FDA UDI
STERNGOLD DENTAL LLC·00841549113024·The ORA System is indicated for use with dental...
PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
FDA 510(k)
FDA Class 2
·Cardiovascular
HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
FDA Adverse Event
Malfunction
·TELEFLEX·Product code CAF·May 27, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 9, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 22, 2010
TO GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024