15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Withings Scan Monitor 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037318126·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STANDARD ...
Zavation
FDA UDI
Zavation LLC·00197157002886·CIF 14x18, 8 deg, -12
Lumbar IBFD
FDA UDI
KEOS·B084KPS12308120·
Lumbar IBFD
FDA UDI
KEOS·B084KPS22308120·
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
SOLUSET 150 X 60 BURETTE SET, LATEX FREE
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FPK·November 6, 2008
OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 23, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·March 4, 2020
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code KCY·January 3, 2020