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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AMSURE BLADDER IRRIGATION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
E2200 Delivery System
FDA UDI
Engle Dental Systems, LLC·00850043433309·Utility Center Mounted AS1 Dr. & Asst Delivery ...
VERTE-STACK ANATOMIC PEEK STRUT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·May 5, 2020
CANALIZER HYDROPHILIC GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
RANDOX AMMONIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LOCKING TITANIUM ADAPTER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·April 22, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·April 15, 2011
CAPTURE-R READY ID
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·July 9, 2008
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM
FDA Adverse Event
Injury
·SYNTHES PRODUKTIONS GMBH·Product code NKG·February 8, 2018
LOCKSCR SYNAPSE TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018
LOCKSCR SYNAPSE TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024