24 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
VARIPULSE™ Bi-Directional Catheter
FDA UDI
Biosense Webster Inc·10846835025460·8.5 FR VARIPULSE™ Bi-Directional Catheter
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515065369·Halsted Mosq Fcps, str, 5"
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837058432·Plateau X Lateral Spacer System - Instrument Set
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523183906·4 Hole, 16 mm, 1-Level Anterior Cervical Plate,...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523183876·4 Hole, 10 mm, 1-Level Anterior Cervical Plate,...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523183883·4 Hole, 12 mm, 1-Level Anterior Cervical Plate,...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523183890·4 Hole, 14 mm, 1-Level Anterior Cervical Plate,...
STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,
FDA 510(k)
FDA Class 2
·Dental
ULTRACLIP II MR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VARIPULSE¿ BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code QZI·February 24, 2026
VARIPULSE¿ BI-DIRECTIONAL CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC.·Product code QZI·January 20, 2026
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 3, 2014
COULTER® AC*T DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 3, 2013
PINNACLE MTL INS NEUT36IDX62OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 22, 2011
VARIPULSE¿ BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code QZI·February 5, 2026
VARIPULSE¿ BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code QZI·December 16, 2025
SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US)
FDA Adverse Event
Injury
·STOCKERT GMBH·Product code LPB·May 1, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·February 19, 2018
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·January 2, 2019