20 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 27, 2011
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040010013·Zirlux 16+ A3.5 100X14
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294383·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294512·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294529·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294536·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294482·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294246·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033294499·
PALCERAM 53
FDA 510(k)
FDA Class 2
·Dental
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
SUMMIT DUOFIX TAP SZ5 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 12, 2015
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 19, 2013
COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 9, 2011
4 FR S/L GROSHONG PICC
FDA Adverse Event
C.R. BARD, INC. (BASD)·Product code LJS·March 10, 2008
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
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