13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
NONIN
FDA Adverse Event
Other
·CAREFUSION 211, INC.·Product code DQA·December 13, 2010
Aligned Medical Solutions
FDA UDI
Aligned Medical Solutions·B09800921010·PICC Tray - RX
MICASEPT ATRAUMATIC DEBAKEY PLEURA GRASPING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896011021·MICASEPT ATRAUMATIC DEBAKEY PLEURA GRASPING FOR...
MICASEPT ATRAUMATIC DEBAKEY PLEURA GRASPING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896011038·MICASEPT ATRAUMATIC DEBAKEY PLEURA GRASPING FOR...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180508190·LIF Novel Peek Loading Block
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
FDA 510(k)
FDA Class 1
·General Hospital
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DWF·June 30, 2005
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·May 3, 2013
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·September 3, 2014
NONE
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code LWS·May 18, 2011
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.
FDA Enforcement
Class II
·Ongoing·Canary Medical, Inc.·July 16, 2025