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

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Elos Accurate Customized Abutment, Elos Prosthetic Screw

FDA 510(k)
FDA Class 2 ·Dental

AED

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018845·Infusion Adapter for 15-1796

BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code MEG·April 18, 2019

MODIFICATION TO BIOSTAR OIA SHIGATOX

FDA 510(k)
FDA Class 1 ·Microbiology

POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·July 22, 2011

SIG MOD TIB TRAY CEM COCR 3

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 17, 2013

BONE SCREW 6.5X40 SELF-TAP

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code MRA·November 21, 2017

CUSTOM PACK CB1Q91R6 NTUH CCS

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code DWE·June 22, 2022

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021