17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 9, 2021
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970560·
CALG-STR EXERCISE ECG ANALYSIS ALGORITHM
FDA 510(k)
FDA Class 2
·Cardiovascular
HAMMER TOE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973479·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970881·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973080·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973707·
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 12, 2011
CRYSTALENS INTRAOCULAR LENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code NAA·October 24, 2014
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
UNITIP CATHETER FOR HR GI
FDA Adverse Event
Injury
·UNISENSOR AG·Product code FFX·August 25, 2014
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·November 27, 2019
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021