33 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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