17 results
·
27ms
·
Sources: EU EUDAMED, US FDA
POTATO DEXTROSE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916493058·Multi-Axial Fenestrated Screw, Ø10.5 x 50mm, Ø5...
Cortera
FDA UDI
Surgalign Spine Technologies, Inc.·00840311233427·Tap, NAV, Cann, 5.5
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055261·OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055241·OVATION® Base Rx 022 UL/5-5 CS-BC MHK
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055221·OVATION® Base Rx 022 UL/5-5 CS-BC DHK
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
FDA 510(k)
FDA Class 2
·Cardiovascular
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·March 16, 2021
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·May 15, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 4, 2012
TRAPEASE PERMANENT VENA CAVA FILTER 90CM
FDA Adverse Event
Malfunction
·CORDIS EUROPA, N.V.·Product code DTK·August 31, 2010
VERSA-DIAL/COMP TI STD TAPER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·January 10, 2019
VERSA-DIAL 46X18X53 HUM HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·January 10, 2019
MD HYBRID GLENOID BASE 4MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 10, 2019
PT HYBRID GLEN POST REGENEREX
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 10, 2019
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021