16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FILAC FAS TEMP ELECTRONIC THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040128589·Cotton Plier 317 College
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964022829·The ENDO CARRY-ON Procedure Kit contains all of...
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00533131·
QUASAR
FDA UDI
Modus Medical Devices Inc·G34350033130·RESP-Split Cedar Insert - single 30mm cavity - ...
TEARAWAY INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
AIRDENT II CS
FDA 510(k)
FDA Class 2
·Dental
PROSTHESIS, HIP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·June 14, 2011
STAR S4 IR
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code LZS·December 9, 2025
REAGENT RED BLOOD CELLS BIOTESTCELL I11 PLUS
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·March 14, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·February 28, 2011
VITROS 250 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·February 27, 2008
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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; 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