18 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FLEXLINE CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890107271·Zirlux Solid Analog 17.3mm
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100270·Assembly, Caddie, Large Cervical Implants, Hinged
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100270·Tray Insert Iliac Screws 12 x 12 Assembly
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·BO73DRK0100270·Rasp, Angled Lumbar
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033213049·
BUFFLIGHT CLT SURGICAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
FDA 510(k)
FDA Class 2
·Anesthesiology
TROCAR
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DYB·June 5, 2018
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
FDA Recall
Open, Classified
·X-NAV Technologies, LLC·Product code QRY·March 4, 2024
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·March 19, 2013
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·March 8, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
FDA Enforcement
Class II
·Ongoing·X-NAV Technologies, LLC·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
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
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016