14 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEALIX ADVANCE SP BIOCOMPOSITE Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Edge™ Diamond ND014-6F Needle
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002639·Diamond dental bur, reusable
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191242001·IN-OVATION® mini Base Rx 022/UL4-5 -7T 0A 2D
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D80719124200R1·IN-OVATION® mini Rhodium Base Rx 022/UL4-5 -7T...
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191242811·IN-OVATION® mini EURO 022/UL4 -7T 0A HK
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191242101·IN-OVATION® mini Base Rx 022/UL4-5 -7T 0A 2D HK
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·September 3, 2019
GENESIS DM MODEL: 6053000A1
FDA 510(k)
FDA Class 2
·Cardiovascular
BANTAM
FDA 510(k)
FDA Class 2
·Physical Medicine
M2A-MAGNUM PF CUP 48ODX42ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·July 19, 2011
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·September 26, 2008
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025