21 results
·
19ms
·
Sources: EU EUDAMED, US FDA
UTERINE TENACLUM HOOK
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Scanlan® SURG-I-BAND® color coding
FDA UDI
SCANLAN INTERNATIONAL INC·00846159001730·Scanlan® SURG-I-BAND® color coding - Labels-Che...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756024327·LAPAROTOMY SPONGES
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967188430·Battalion, LLIF Trial, 0°, 18 mm Wide, 18 mm X ...
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 30, 2026
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 30, 2026
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
FDA 510(k)
FDA Class 2
·Immunology
CORRECT PLUS
FDA 510(k)
FDA Class 2
·Dental
LEADST,5LEAD,EXT,SNAP,24",AAMI
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904059372·
LEADST,5LEAD,EXT,SNAP,36",AAMI
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904059389·
LEADSET,5LEAD,EXT,SNAP,24",IEC
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904059396·
LEADSET,5LEAD,EXT,SNAP,36",IEC
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904059402·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973684·
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 13, 2013
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·February 25, 2011
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·February 19, 2008
Xhibit Telemetry Receiver, Model: 96280
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024