21 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BEHRING COAGULATION SYSTEM (BCS)
FDA 510(k)
FDA Class 2
·Hematology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092117033·NobelActive™/Conical-compatible RP Esthetic Abu...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040044179·Tenotomy Scissor Stevens Blunt
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964008922·Endo Carry-On Procedure Kit
AtriClip® PRO•V™ LAA Exclusion System
FDA UDI
ATRICURE, INC.·00818354015140·AtriClip® PRO•V™ LAA Exclusion System 45
AtriClip® PRO•V™ LAA Exclusion System
FDA UDI
ATRICURE, INC.·10840143900235·AtriClip® PRO•V™ LAA Exclusion System 45
AtriClip® PRO•V™ LAA Exclusion System
FDA UDI
ATRICURE, INC.·10840143907647·AtriClip® PRO•V™ LAA Exclusion System 45
AtriClip® PRO•V™ LAA Exclusion System
FDA UDI
ATRICURE, INC.·10840143912122·LAA Exclusion System, PROV45
AtriClip® PRO•V™ LAA Exclusion System
FDA UDI
ATRICURE, INC.·10840143901225·AtriClip® PRO•V™ LAA Exclusion System 45
MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
FDA 510(k)
FDA Class 2
·Neurology
CEMENT IT! UNIVERSAL C&B
FDA 510(k)
FDA Class 2
·Dental
DEXCOM FOLLOW APP
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 2, 2025
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 18, 2011
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·February 18, 2008
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 15, 2026
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
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018