10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BioSci™
FDA UDI
Shenzhen Dakewe Bio-engineering Co., Ltd·06973471960927·1 mL of Transport Medium in screw-cap tube, wi...
BioSci™
FDA UDI
Shenzhen Dakewe Bio-engineering Co., Ltd·16973471969996·1 mL of Transport Medium in screw-cap tube, wi...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198895·AK3 Congruent Insert Trial Size 1, 11mm
DD Solid Connect® CAD/CAM Abutments
FDA 510(k)
FDA Class 2
·Dental
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
FDA 510(k)
FDA Class 2
·Anesthesiology
MM10 SVN W/ADULT MASK & 7FT TBG 50/CS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CAF·March 6, 2013
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
ENRHYTHM MRI
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·August 8, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024