11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AIAS Cephalon
FDA 510(k)
FDA Class 2
·Radiology
Vu ePOD™
FDA UDI
Seaspine Orthopedics Corporation·10889981048754·22mm Trial, 5 Deg, 14 mm
NA
FDA UDI
aap Implantate AG·04042409194726·Angle Stable Cortical Screw 2.5, self-tapping, ...
IFM Surgical Mask Model SM3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRE-POWDERED STERILE EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 16, 2011
MINIMARK DENTAL IMPLANT SYSTEM
FDA Adverse Event
Injury
·ACE SURGICAL SUPPLY CO.·Product code DZE·July 25, 2013
STERILE 3.0 SOFT KOH-EFF
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HEW·May 29, 2019
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025