15 results
·
26ms
·
Sources: EU EUDAMED, US FDA
EMBRIA-CK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Preat
FDA UDI
Preat Corporation·00842092129692·Sphero Block Abutment Ankylos 4.5 x 1mm (1.8mm ...
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006793·VITROS Chemistry Products dLDL Reagent
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031674·Rhoton® Needle Holder, Bayonet, Straight Tip, 8...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209132546·
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580172800001·SURE-SNAP 2. MOLAR UPR RGT SZ 28
HARDY DISK CLARITHROMYCIN, 15MCG
FDA 510(k)
FDA Class 2
·Microbiology
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
ASR TAP SLV ADAP 11/13 +0
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·October 23, 2012
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·February 11, 2014
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 16, 2010
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 28, 2018
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code MRR·October 8, 2018
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022