31 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COLLAGEN DENTAL MEMBRANE V
FDA 510(k)
FDA Class 2
·Dental
Bioliner Plus
FDA UDI
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC·D82851001560·
PGI
FDA UDI
Nuvasive, Inc.·00887517419941·PGI Rasp, Straight
QUICKIE XTENDER
FDA Adverse Event
Injury
·SUNRISE MEDICAL (US) LLC·Product code KNN·November 20, 2020
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450172148·
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151801·IN-OVATION® C EURO 018 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151101·IN-OVATION® C Base Rx 018 UP5-5 CHK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151111·IN-OVATION® C Base Rx 018 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151811·IN-OVATION® C EURO 018 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151001·IN-OVATION® C Base Rx 018 U5-5
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SLEEP PAT 200 DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152111·IN-OVATION® C Base Rx 022 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152611·IN-OVATION® C Roncone 022 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152101·IN-OVATION® C Base Rx 022 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152001·IN-OVATION® C Base Rx 022-U5-5
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152801·IN-OVATION® C EURO 022 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152811·IN-OVATION® C EURO 022 U5-5 CS-BC HK
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·May 3, 2023