11 results
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20ms
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Sources: EU EUDAMED, US FDA
SCALPEL, SURGICAL, STERILE STAINLESS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NexxZr Plus Multi 2.0 A3.5 W98-16mm
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271158420·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110591·COAXIAL IRRIGAT-ASPIRAT TIP 90 DEG ASP
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110607·COAXIAL IRRIGAT-ASPIRAT TIP 160 DEG SIDE
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
FDA 510(k)
FDA Unclassified
·Unknown
OPTIMUS CMF SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MENTOR MEMORYGEL BOOST BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·November 14, 2023
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012
QUADRA ASSURA MP CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·May 8, 2015
ULTRASOFT LANCING DEV
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 18, 2010
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics, Inc.·March 12, 2025