12 results · 21ms · Sources: EU EUDAMED, 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