11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALCITONIN RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199496·Revision Knee Spiral Reamer- Hudson Long Flutes...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209127467·
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11 X 360MM X 12
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 6, 2012
ENZYGNOST LIPASE TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KM PRODUCTS SUCTION TIPS
FDA 510(k)
FDA Class 2
·General Hospital
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 6, 2014
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.·Product code BTR·November 27, 2012
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·September 3, 2010
Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
FDA Recall
Terminated
·Contamac Solutions, Inc.·Product code MRC·July 27, 2021
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·February 22, 2017