15 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Injection Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981038267·39x30mm Trial 14mm 12 deg. The Vu a-POD interve...
POWDERFREE LATEX SURGEON'S GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RESTORELLE Y CONTOUR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
ASR UNI FEMORAL IMPL SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
VERSACARE FRAME
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 6, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
G7 NEUTRAL E1 LINER 32MM G
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·June 12, 2024
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
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019