14 results · 27ms · Sources: EU EUDAMED, US FDA

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RK IV SURGICAL BLADES

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

Bioplate®

FDA UDI
Bioplate, Inc.·M3848120711·Self-Drilling Screw - Ø1.5 mm x 3 mm [5 PK]

Bioplate®

FDA UDI
Bioplate, Inc.·M384812071US1·Self-Drilling Screw - Ø1.5 mm x 3 mm [5 PK]

IV SET AN120 W/O BP

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code LHI·February 20, 2019

WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ENT LASERVISION

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

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 15, 2014

ATTAIN OTW

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

C-ARM

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·August 17, 2010

MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

FDA Adverse Event
Injury ·COOK INC·Product code KRA·April 27, 2022

MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·April 11, 2022

MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·August 19, 2022

GENERAL SPHERE INSTRUMENT SET

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·March 22, 2019

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

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