14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
FDA 510(k)
FDA Class 2
·Hematology
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095620109·Filter tip, 1-100uL, 54mm, low retention, unive...
HHM
FDA UDI
Oticon A/S·05707131280794·H160V2, BTE 13 WL 100 STG HHM
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100080·TEMPORAL SPECULUM OPEN WIRE
OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316
FDA 510(k)
FDA Class 2
·Cardiovascular
XACT.CARDIAC & XPRESS.CARDIAC
FDA 510(k)
FDA Class 2
·Radiology
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 2, 2020
END-CAP F/A2FN CANN EXTENS. 10 TAN GREY
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code HSB·October 8, 2014
THORATEC PVAD
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 6, 2013
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 21, 2011
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026