15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Premier Curettes
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783007794·CURETTE DE SURGICAL 86
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040022580·Scissor 268 Kelly Curved
EndoGator Hybrid
FDA UDI
MEDIVATORS INC.·00724995224059·EndoGator Tubing Hybrid, Olympus is used with E...
SCANLAN® Titanium Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159012088·Micro Forceps, Round Handle, 1 mm DD ring tips,...
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
BD DIRECTIGEN FLU A+B
FDA 510(k)
FDA Class 2
·Microbiology
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
BD DISCARDIT II 10 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 24, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·August 12, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·February 28, 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
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