14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile
FDA 510(k)
FDA Class 1
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00845694047029·PrimaLIF LLIF PEEK Implant, 17mm X 18mm X 50mm,...
MaxFuse,VBR, 12 (D) x 14 (W) x 31 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468056247·12 (D) x 14 (W) x 31 (H)
Phantom Hindfoot TTC/TC Nail System
FDA UDI
Paragon 28, Inc.·00889795135865·Phantom ActivCore Nail, 11.5 X 175mm
Phantom Hindfoot TTC/TC Nail System
FDA UDI
Paragon 28, Inc.·00889795097743·Phantom ActivCore Nail, 11.5 X 175mm
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
FDA 510(k)
FDA Class 2
·Dental
RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code OJX·June 7, 2013
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 6, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 8, 2014
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 28, 2025
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 3, 2025
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016