10 results
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22ms
·
Sources: EU EUDAMED, US FDA
AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037318195·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY...
PQ Pouches 3 1/2 x 10"(200) Blue
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724P2309151·Pk. of 200
GRANDIO
FDA 510(k)
FDA Class 2
·Dental
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENDURON 10D 52OD X 28ID
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·September 1, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
FDA Enforcement
Class II
·Ongoing·Future Diagnostics Solutions B.V.·February 1, 2023
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025