11 results · 20ms · Sources: EU EUDAMED, US FDA

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ViSi Mobile Monitoring System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Mouse anti-Pax5 (ZP007) Concentrate

FDA UDI
LIFE TECHNOLOGIES CORPORATION·10190302008068·

POOLE SUCTION

FDA UDI
SONTEC INSTRUMENTS, INC.·B0991804270·POOLE SUCTION WITH VALVE

All Poly Monotrial UC

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215081294·

SEDAT MYSHELL LITE

FDA 510(k)
FDA Class 2 ·Cardiovascular

SI-FIX SACROILIAC JOINT FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·July 27, 2011

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

BRAUN

FDA Adverse Event
Injury ·B.BRAUN MEDICAL INC.·Product code KPE·September 29, 2008

Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024