34 results · 20ms · Sources: EU EUDAMED, US FDA

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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