47 results
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42ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707183615·Accufit Molar Bands Lower Left First Molar 36
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856049451·ZODIAC ULTRA SS STRAIGHT ROD 5.5 X 60CM
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054844·METZENBAUM SCISSORS STRAIGHT BLADES POWER CUT GOLD
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113387·ALIO MICS TRAP KNIFE (BX/5)
Ditron Dental
FDA UDI
DITRON DENTAL LTD·07290109284422·Multi-Unit Motor Mount Driver
Quala
FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·D0232003601·Quala Light Handle Cover T-Style
Sonoma™
FDA UDI
Seaspine Orthopedics Corporation·10889981050924·Sonoma Anterior Cervical Plate 3 Level Plate, 60mm
ABR-2000
FDA 510(k)
FDA Class 2
·Neurology
RX G-UNIVERSAL
FDA 510(k)
FDA Class 2
·Dental
Manta Ray™
FDA UDI
Seaspine Orthopedics Corporation·10889981057206·Plate - 3 Level - 60 mm
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·September 16, 2019
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 6, 2015
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·June 20, 2016
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 2, 2019
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·June 24, 2020
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·July 27, 2018
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·July 27, 2018
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 26, 2016
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 6, 2021