13 results
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24ms
·
Sources: EU EUDAMED, US FDA
Facet Blood Lancets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DTE
FDA UDI
Guilin Woodpecker Medical Instrument Co., Ltd.·06944843657769·Dental X-Ray Device
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PHFW-10
FDA 510(k)
FDA Class 2
·Physical Medicine
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·November 6, 2008
SUBTALAR MBA IMPLANT 14MM
FDA Adverse Event
Other
·INTEGRA, CINCINNATI·Product code MJW·August 11, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 12, 2013
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 28, 2023
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 25, 2025
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 30, 2025
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020