17 results · 21ms · Sources: EU EUDAMED, US FDA

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SIS Inguinal Hernia Repair Graft

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ACCU-CHEK SPIRIT

FDA 510(k)
FDA Class 2 ·General Hospital

ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

FDA Enforcement
Class II ·Ongoing·ICU Medical, Inc.·May 19, 2021

SHIDEN HP

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·June 4, 2019

G7 FREEDOM CONST E1 LNR 32MM C

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·April 6, 2018

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 3, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 12, 2014

UNKNOWN DEPUY ACETABULAR LINER

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 23, 2011

SHIDEN HP

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·March 1, 2024

SHIDEN

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·July 10, 2020

DIVA

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

DIVA

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

SHIDEN HP

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·April 18, 2022

SHIDEN

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·September 2, 2021

SHIDEN

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·January 6, 2022

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018