21 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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