9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SHUR-STRIP APPLICATOR
FDA 510(k)
FDA Class 1
·General Hospital
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268217631·CUSTOM SURGICAL KIT, VEIN PACK
RS2MI MUSCLE STIMULATOR FAMILY
FDA 510(k)
FDA Class 2
·Physical Medicine
MULTICROSS SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 20, 2014
UV FLASH TRANSFER SETS
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 6, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 25, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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