20 results
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23ms
·
Sources: EU EUDAMED, US FDA
WELCH ALLYN INSTRUMENT INTERFACE MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
Preat
FDA UDI
Preat Corporation·00842092182918·ASC Straumann® TL-compatible RN Titanium Blank
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00126051·
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00126451·
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18052469476673·FITBONE TROCHANTERIC TRIAL NAIL L265MM D11MM
ActivHeal
FDA UDI
ADVANCED MEDICAL SOLUTIONS LIMITED·15032749001262·SILICONE WOUND CONTACT LAYER 10x20CM
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001265·artVeneer life upper anteriors, CM, B4
Preat
FDA UDI
Preat Corporation·00842092183328·ASC Straumann® TL-compatible RN – Milled Ti Abu...
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
SEXTANT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009
CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Malfunction
·THERAKOS, INC.·Product code LNR·February 27, 2020
CAREASSIST BED
FDA Adverse Event
Other
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·March 1, 2013
ADMIN.SET FOR BLOOD/BLOOD/DERIVATIVES
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code BRZ·February 25, 2011
THERMOPHORE ARTHRITIS PAD
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·February 18, 2008
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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024