20 results
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29ms
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Sources: EU EUDAMED, US FDA
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00143381·
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001338·artVeneer life upper anteriors, BOM, C2
OptiMesh Multiplanar Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7401001338·TLIF Portal Anchor, Angled 4mm
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 21, 2025
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494463112·Tendon Stripper Closed
OD 9.5mm, WL 330mm
UniTip Catheter
FDA UDI
Unisensor AG·07640172971673·
VITAPORT 3
FDA 510(k)
FDA Class 2
·Neurology
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
FDA 510(k)
FDA Class 2
·Cardiovascular
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·June 15, 2018
TEMA ELBOW
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code JDB·October 2, 2025
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·March 6, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·February 25, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·February 19, 2008
Xhibit Telemetry Receiver, Model: 96280
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024