34 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Implant Prosthetics
FDA UDI
Preat Corporation·00842092127254·ASC Zimmer TSV Screw
AIM 200
FDA UDI
Burton Medical, LLC·00858480006063·LIGHT HEAD
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014600772·E-Z Lift Beach Chair (EU) - Skytron
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014601083·MIZUHO OSI EZ LIFT ASSIST BEACH CHAIR W/O PAD
NEONATAL SCANNING PLATFORM, NL5000
FDA UDI
NEUROLOGICA CORP.·10815411020427·
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555244000154·Preference 2 Mini Tray 2 Optional Inst. Assembly
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
FDA 510(k)
FDA Unclassified
·Unknown
RS-4M+MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·May 11, 2021
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·May 11, 2021
BD SEDI-40
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·October 21, 2021
GLIDESCOPE COBALT AVL MONITOR, PACK
FDA Adverse Event
Malfunction
·VERATHON MEDICAL (CANADA) ULC.·Product code CCW·February 14, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·February 18, 2011
DEEP BRAIN STIMULATOR LEAD
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·February 15, 2008
IMPELLA 5.5
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·October 4, 2025
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).
FDA Enforcement
Class II
·Terminated·Insulet Corporation·April 1, 2020
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