12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PERF CON TIB BRG XSML 22X60
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·March 23, 2018
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9362741·SIC Bar Coping "Safe on Four" (incl. SIC Fixati...
SeaSpine Spacer System - Redondo™
FDA UDI
Seaspine Orthopedics Corporation·10889981045524·Redondo Trial 34mm x 24mm x 10mm, 12 Deg
MIST MICROSURGICAL MONOPOLAR SCISSORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME
FDA 510(k)
FDA Class 2
·Immunology
OMNIPOD INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·June 1, 2020
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 30, 2013
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 22, 2010
AGILITY POST AUG TALAR SZ 3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSN·July 15, 2014
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