19 results
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73ms
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Sources: EU EUDAMED, US FDA
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
FDA 510(k)
FDA Class 2
·General Hospital
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001368·artVeneer life upper anteriors, BM, C3
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450157268·
Elite Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7401001368·CEI 595 Shaver, 14mm
Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007
NBS CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EYECAP IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
0001222315-2025-001368
FDA Adverse Event
Injury
·STRAUMANN MANUFACTURING, INC.·Product code DZE·June 18, 2025
HT50-H VENTILATOR
FDA Adverse Event
Injury
·FLIGHT MEDICAL·Product code CBK·March 11, 2013
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Injury
·CORDIS EUROPA, N.V.·Product code DTK·February 25, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·February 20, 2008
HANDLE BATTERY POWERED DRIVER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·March 5, 2025
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.
FDA Enforcement
Class II
·Ongoing·Physio-Control, Inc.·November 6, 2024
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
FDA Enforcement
Class II
·Terminated·Avanos Medical, Inc.·May 6, 2020
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.
FDA Recall
Open, Classified
·Physio-Control, Inc.·Product code MKJ·August 30, 2024
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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
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
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024