14 results
·
26ms
·
Sources: EU EUDAMED, US FDA
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613275030·
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613201824·
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613201800·
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613201787·
Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PERVENOUS LEAD INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
OXF ANAT BRG RT LG SIZE 3 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·May 30, 2019
OXF TWIN-PEG CMNTD FEM LG PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·May 30, 2019
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·January 26, 2011
BATTERY HANDPIECE/MODULAR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·July 31, 2014
INRATIO
FDA Adverse Event
Injury
·HEMOSENSE, INC.·Product code GJS·May 13, 2008
VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA
FDA Adverse Event
Malfunction
·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025