25 results · 21ms · Sources: EU EUDAMED, US FDA

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NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW

FDA 510(k)
FDA Unclassified ·Unknown

ODYSSEY®

FDA UDI
Microport Orthopedics Inc.·M684K00143231·

Gensini™

FDA UDI
MEDTRONIC, INC.·00763000199135·WVN CATH 001323 10PK 5425 5 100 GENSINI

Gensini™

FDA UDI
MEDTRONIC, INC.·00613994964632·WVN CATH 001323 10PK 5425 5 100 GENSINI

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001323·artVeneer life lower anteriors, UBS, C1

FAA Airline - 24 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588013237·FAA Airline - 24 Metal

Rampart One Lumbar Interbody Fusion System

FDA UDI
SPINEOLOGY INC.·M7401001323·Trial 12mm L 12°

DISPOSABLE TIPS

FDA UDI
DiaDent Group International·08806383586696·DISPOSABLE SYRINGE TIPS

NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE

FDA 510(k)
FDA Class 1 ·General Hospital

FREEDOM, MODEL 4660

FDA 510(k)
FDA Unclassified ·Unknown

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·May 27, 2026

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·March 7, 2026

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·September 2, 2025

SINGLE USE BILIARY STENT V

FDA Adverse Event
Injury ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FGE·March 5, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·February 24, 2011

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·February 19, 2008

MINMED QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·August 8, 2024

TECNIS IOL

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·May 13, 2026

Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.

FDA Enforcement
Class I ·Ongoing·Insulet Corporation·January 10, 2024

Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.

FDA Recall
Open, Classified ·Product code QFG·November 30, 2023