26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System
FDA 510(k)
FDA Class 2
·Neurology
LoFric® Elle™
FDA UDI
Wellspect AB·07333387023830·Single Use Urinary Catheter LoFric Elle Nelaton...
LoFric® Elle™
FDA UDI
Wellspect AB·07392532235368·Single Use Urinary Catheter LoFric Elle Nelaton...
AIM™SUPRACONDYLAR NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868005282·
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158212053·DILATOR DEBAKEY VASCULAR MALLEABLE 2.5MM 7.5"
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515024281·Middledorpf Retractor, ring handle, 30x26 mm, 9...
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869642330·MOSS Ti Pedicle Screw, Ø10.0x25mm DL, polyaxial...
ISOELASTICU
FDA 510(k)
FDA Class 2
·Orthopedic
TRIGEN LOW PROFILE BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·April 15, 2020
E-Z CLEAN BLADE MOD 2.75IN
FDA Adverse Event
Malfunction
·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·August 29, 2019
INSERTER F/TEN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 20, 2013
PLUM XLM W/DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 7, 2011
VECTRA GENISYS 2CH COMBO
FDA Adverse Event
Malfunction
·CHATTANOOGA GROUP·Product code IMG·September 23, 2008
BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·April 28, 2023
SINGLE USE GUIDWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 29, 2020
SINGLE USE GUIDWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 24, 2020
SINGLE USE GUIDWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 24, 2020
SINGLE USE GUIDWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 24, 2020