18 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pantera LEO
FDA 510(k)
FDA Class 2
·Cardiovascular
Biomet® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868264818·
Biomet® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868308253·
BIOMET HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256507·
LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
FDA 510(k)
FDA Class 2
·Neurology
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·April 17, 2024
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 6, 2019
BIO-CLAD POLY ACETABULAR CUP 28 MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·October 26, 2016
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 12, 2018
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
STEALTHSTATION® S7
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 18, 2019
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·October 10, 2014
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Other
·WAVELIGHT GMBH·Product code LZS·June 10, 2011
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 19, 2008
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; 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
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025