20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
I-STAT SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040010006·Zirlux 16+ A3 100X14
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033295991·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033296011·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033296028·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033295977·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033296004·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033296035·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033295984·
AURECAST SUPER INLAY
FDA 510(k)
FDA Class 2
·Dental
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 27, 2011
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·March 19, 2013
COLLEAGUE 3 TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP CE FRENC
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 9, 2011
2250051-2008-00081
FDA Adverse Event
Malfunction
·Product code ---·February 8, 2008
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 14, 2022
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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