15 results · 23ms · Sources: EU EUDAMED, 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