13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CAPSTONE PTC™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169187344·SPACER 3993208 32MM X 8MM
artegral life
FDA UDI
Merz Dental GmbH·D7091993208·anteriors; shade B2; mould BIL
LEONE SPA
FDA UDI
LEONE SPA·08033707065814·EXTRAORAL ELASTICS 3/16" 8 oz
MAXI-FLOW INSUFFLATOR TUBING SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SIMPLISEAL
FDA 510(k)
FDA Class 2
·Dental
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
ACCU-CHEK ® SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC·Product code LZG·March 7, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 7, 2011
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025