12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAICHEM GPT (ALT) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551001103·Kidney-Shaped Dressing Tray, 25 cm
LEONE SPA
FDA UDI
LEONE SPA·08033707028062·WEB 1ST MOLAR BANDS n.UR 25
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
QLAB QUANTIFICATION SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
RESPONDER Polysaccharide Hemostat
FDA 510(k)
FDA Unclassified
·Unknown
SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GDW·May 20, 2014
PDL IMPLANT
FDA Adverse Event
Injury
·Product code MJO·November 6, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 30, 2010
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