19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Heavy Double Flexible Tipped Wire Guide
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699540·GENUMEDI PSS BLUE SIZE II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768468·GENUMEDI PSS GREEN II
BIOMET PATELLAR SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304240230·
Biomet® Patellar System
FDA UDI
Biomet Orthopedics, LLC·00887868241642·
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180525579·14 mm Stopped Awl Bevel Tip
LEONE SPA
FDA UDI
LEONE SPA·08033707071464·MINI ORTHODONTIC IMPLANT HIGH D1,5 L8 mm
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RESOLUTION 360 CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·December 2, 2024
PHILIPS SONICARE
FDA Adverse Event
Injury
·PHILIPS ORAL HEALTHCARE·Product code JEQ·July 9, 2018
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 21, 2018
ORTHOLOC® DRILL BIT 1/8
FDA Adverse Event
Malfunction
·MICROPORT ORTHOPEDICS INC.·Product code GFG·December 2, 2019
UNKNOWN DEPUY 32MM FEMORAL HEAD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·October 8, 2014
TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 6, 2013
OCTRODE LEAD, 30CM LENGTH
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 21, 2011
SCREWDRIVER
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code HXX·January 24, 2025
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JWH·August 25, 2017
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018