21 results · 21ms · Sources: EU EUDAMED, US FDA

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Gianturco-Roehm Bird’s 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