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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APR -T REVISION HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981211·anteriors; shade B3; mould UL4
Symmetry Surgical®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482086681·Symmetry® Forceps, Kocher Grasping, Ratcheting ...
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575183296·Femoral component, TiNbN coating, cemented, CoC...
Octane A
FDA UDI
Choice Spine, LP·10885862166630·
TRU-TECH 310 ULTRASOUND THERAPY UNIT #310
FDA 510(k)
FDA Class 2
·Physical Medicine
Human Tecar HCR 1002
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HALF RING 180 MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KTT·February 27, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·January 31, 2011
OLYMPUS SURGMASTER ELECTROSURGICAL UNIT
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·July 23, 2014
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025