21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777501·LUMBAMED PLUS FLEX PAD M SILVER III
LuxaCore® Automix Dual Intro Kit
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2120330·Automix core build-up composite. Core buildups ...
QUICKANCHOR ETHIBOND
FDA UDI
DEPUY MITEK, LLC·20886705001818·Mini QUICKANCHOR Plus (Number 2/0 Suture) Size ...
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981293550·No-Profile Interbody, 35mm x 27mm x 20mm, 33 Deg
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351103353·LAP-Instrument, Ø5mm, l=330mm, flushp.
Hook s...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351105517·LAP-Instrument, Ø5mm, l=330mm, detach.
Hook s...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351118197·LAP-Insert only, Ø5mm, l=330mm
Hook s...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351113291·LAP-Instrument, Ø5mm, l=330mm, detach.
Hook s...
EN SNARE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code MMX·September 8, 2011
ENSEAL G2 TISSUS SEALERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MULTIFUNCTION ENDOSCOPIC INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MITEK MINI ANCHOR
FDA Adverse Event
Injury
·DEPUY MITEK / JOHNSON & JOHNSON CO.·Product code MBI·August 4, 2004
ST. JUDE MEDICAL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code LWQ·October 24, 2008
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·July 8, 2013
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
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024