18 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REPROCESSED FEMORAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
FEMOSTOP
FDA Adverse Event
Malfunction
·RADI MEDICAL SYSTEMS, INC.·Product code MGB·November 21, 2003
FEMOSTOP
FDA Adverse Event
Injury
·RADI MEDICAL SYSTEMS·Product code DXC·August 20, 2003
PERFORMATRAK
FDA UDI
Respironics, Inc.·00606959007581·Performatrak Mask with Headgear, Disposable, In...
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033427378·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033427392·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033427385·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021383300·
UNIPLANT DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
FDA 510(k)
FDA Class 2
·Cardiovascular
QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 18, 2025
RICHARD ALLEN SURGICAL NEEDLE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, INC.·Product code GAB·February 21, 2013
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·February 28, 2011
PLUS
FDA Adverse Event
Injury
·PLUS ORTHOPEDICS AG·Product code KWY·March 12, 2008
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019
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
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·March 27, 2024