19 results · 21ms · Sources: EU EUDAMED, 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