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