13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIPOLAR TRIGGER-FLEX PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00311261·
ISOLA
FDA UDI
DEPUY SPINE, LLC·10705034006215·ISOLA SPINE SYSTEM CLOSED ANGLED THROAT HOOK 6....
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315811409·CL CDKN2A 4x conc., 2x 125µl
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
FDA 510(k)
FDA Class 2
·Cardiovascular
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
30 G X 1/2 IN. BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE
FDA Adverse Event
Injury
·BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS·Product code FMI·March 16, 2016
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 26, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·February 15, 2011
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
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024