25 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACL TIGHTROPE
FDA 510(k)
FDA Class 2
·Orthopedic
DEBAKEY VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921006520·DEBAKEY VASCULAR CLAMP ANGLED JAW CURVED SHANK
VOLKMAN RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896049253·VOLKMAN RETRACTOR SHARP PRONGS
DEBAKEY VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896088313·DEBAKEY VASCULAR CLAMP ANGLED JAW CURVED SHANK
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
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552821·IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552811·IN-OVATION® C EURO 022 U5-5/L3-3 CS HK
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·September 29, 2022
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LOX·May 8, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
UNKNOWN DEEP BRAIN STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·May 17, 2011
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·January 18, 2016
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 7, 2013