36 results
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19ms
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Sources: EU EUDAMED, US FDA
TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MaXcess
FDA UDI
Nuvasive, Inc.·00887517179012·MaXcess Pituitary, 4mm Short Up Micro
Spring-Loaded Aligner
FDA UDI
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC·D82851001550·
ELMED
FDA UDI
ELMED INCORPORATED·00842180163942·Magill Catheter Introducing Forceps 25cm, 9-3/4"
VISULUX®
FDA UDI
Carl Zeiss Meditec AG·04049539102430·
BLOOD PRESSURE METER, MODEL CH-609
FDA 510(k)
FDA Class 2
·Cardiovascular
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
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.·D807K100152111·IN-OVATION® C Base Rx 022 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.·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.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK
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 G5 SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code OYC·April 11, 2019