12 results
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20ms
·
Sources: EU EUDAMED, US FDA
LaserCap LC Pro and LC Elite
FDA 510(k)
FDA Class 2
·Physical Medicine
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028109·PESSARY, DISH #0, W/O SUPPORT, 50mm
SYRINGE 20ML LL TIP CONV PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·November 6, 2023
BIOMED WOUND CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
QUANTIA BETA-2 MICROGLOBULIN
FDA 510(k)
FDA Class 2
·Immunology
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
FIBERED IDC OCCLUSION SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KRD·June 6, 2013
GREENLIGHT MOXY
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 22, 2011
TREVO XP PROVUE 4MM X 30MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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