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