17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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