15 results · 19ms · Sources: EU EUDAMED, US FDA

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MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03

FDA 510(k)
FDA Class 2 ·Orthopedic

TruForm

FDA UDI
Rmo, Inc.·00885797099815·MX 1-2 BI BD KT N/L UNIV 131

L20-5U Ultrasonic Probe(FDA)

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088495·

FLEXTIME

FDA 510(k)
FDA Class 2 ·Dental

DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM 24G X 0.75 IN WITH Y ADAPTER

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·October 10, 2017

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·February 11, 2013

EZ-28 DELIVERY SYSTEM

FDA Adverse Event
Injury ·BAUSCH & LOMB·Product code MSS·February 23, 2011

PROXIMATE PPH PROCEDURE SET

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GDW·February 15, 2008

APTIMA SARS-COV-2 ASSAY

FDA Adverse Event
Malfunction ·HOLOGIC INCORPORATED·Product code QJR·June 10, 2022

APTIMA SARS-COV-2 ASSAY

FDA Adverse Event
Malfunction ·HOLOGIC INCORPORATED·Product code QJR·June 10, 2022

APTIMA SARS-COV-2 ASSAY

FDA Adverse Event
Malfunction ·HOLOGIC INCORPORATED·Product code QJR·June 10, 2022

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

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

Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018