33 results · 22ms · Sources: EU EUDAMED, US FDA

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SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

FDA 510(k)
FDA Class 2 ·Hematology

PowerPICC

FDA UDI
Bard Access Systems, Inc.·00801741096174·Catheter Placement Kit

TEWA

FDA UDI
asia-med GmbH·04251282508746·TeWa 5CB-Type 2240 Speed Pak: coated acupunctu...

TEWA

FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501426·TeWa 5CB-Type 2240 Speed Pak: coated acupunctu...

GeneXpert Dx System

FDA UDI
CEPHEID·07332940006761·XPERT, GENEXPERT DX SYSTEM

CORTEK ARTHROSCOPE

FDA 510(k)
FDA Class 2 ·Orthopedic

SOFTLINE SPRING CLIP

FDA 510(k)
FDA Class 2 ·Cardiovascular

REVERSE #SHORT HUM. BODY 140°

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A·Product code MBF·November 11, 2022

REVERSE #SHORT HUM. BODY 140°

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A·Product code MBF·November 11, 2022

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 4, 2023

XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·March 12, 2013

UNKNOWN

FDA Adverse Event
Injury ·UNK·Product code DTB·February 23, 2011

UNK DEPUY FEMORAL

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSA·February 19, 2008

VERCISE GENUS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·June 30, 2023

BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

FDA Adverse Event
Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026

Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014

BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

BrightView XCT

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017

BrightView XCT , Model Number 882482

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019

BrightView XCT, Gamma Camera, Product Code 882482

FDA Enforcement
Class II ·Ongoing·Philips North America·January 17, 2024