13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIR-FLOW handy 3.0 PLUS
FDA 510(k)
FDA Class 1
·Dental
CASTROVIEJO NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896017757·CASTROVIEJO NEEDLE HOLDER WITH LOCK STRAIGHT TU...
CASTROVIEJO NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896017702·CASTROVIEJO NEEDLE HOLDER WITH LOCK STRAIGHT TU...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100264·KATENA DBL-X ASPIRATING SPECULUM K-WIRE
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311519120·
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B
FDA 510(k)
FDA Class 2
·Cardiovascular
THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 26, 2024
MPACT FLAT PE HC LINER Ø32/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 16, 2024
SINGLE 8
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 6, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014