15 results · 29ms · Sources: EU EUDAMED, US FDA

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Mitsar-EEG

FDA 510(k)
FDA Class 2 ·Neurology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814268·GENUMEDI PT SILVER R III

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526550179·GENUMEDI PT KNEE SUP SILVER R EW III

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613106898·Vienna Original Nasal Speculum, Number 2, 30mm ...

MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT

FDA 510(k)
FDA Class 2 ·Orthopedic

GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2025

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·February 1, 2017

VICTORY XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code LWP·January 13, 2014

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 3, 2013

OT VERIO SYNC METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2015

RELION INSULIN SYRINGE

FDA Adverse Event
Injury ·BD MEDICAL - DIABETES CARE·Product code FMF·June 5, 2020

GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 12, 2017

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015