21 results
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21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Gianturco-Roehm Birds Nest Vena Cava Filter
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·March 23, 2018
Symmetry Rochester Ochsner
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482039854·Symmetry® Forceps, Rochester Ochsner, Straight,...
THREADED STEINMANN PINS, TROCAR POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016400·
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 11, 2018
PATCHASSIST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 13, 2018
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 26, 2025
VIDAS® MUMPS IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LJY·February 24, 2016
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·July 13, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·September 17, 2008
LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region
FDA Enforcement
Class II
·Terminated·Teleflex Medical·October 4, 2017
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020