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