19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
FDA 510(k)
FDA Class 2
·Anesthesiology
Probe holder, (V2) Biim Ultrasound
FDA UDI
Biim Ultrasound AS·07090045490051·Probe holder, (V2) Biim Ultrasound
Essential Kit
FDA UDI
MEDIVATORS INC.·40677964010901·Essential Kit includes Suction Tubing, DEFENDO ...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001137·artVeneer life upper anteriors, BM, A4
CURE LP
FDA UDI
MEDITECH SPINE, LLC·B167900011370·
CURE LP
FDA UDI
MEDITECH SPINE, LLC·B167S1900011370·
CURE LP
FDA UDI
SpineArt SA·07640270060804·LATERAL LUMBAR PLATE L37
MODIFICATION TO EBI SPINELINK SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENHANCED COMPENSATING FILTER
FDA 510(k)
FDA Class 2
·Radiology
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 28, 2018
SILK SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAP·March 28, 2018
iBOT PMD with software version 01.05.24. Personal Mobility Device.
FDA Enforcement
Class II
·Ongoing·Mobius Mobility LLC·June 18, 2025
IMPAX
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013
FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU
FDA Adverse Event
Other
·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·February 18, 2011
5.5MM SHORT SECONDARY PORT
FDA Adverse Event
Malfunction
·PONCE - USS·Product code GCJ·February 15, 2008
ALARIS® PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·January 8, 2018
BD PHASEAL¿ PROTECTOR (P14)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·February 9, 2022
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025