12 results
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18ms
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Sources: EU EUDAMED, US FDA
PERIODONTIC TOOTHBRUSH, #0126-0190-00
FDA 510(k)
FDA Class 1
·Dental
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292916·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012672·K-Wires, Single trocar, .062-inch (1.6mm) diame...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049286·K-Wires, Single trocar, .062-inch (1.6mm) diame...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484467·K-Wire w. trocar/round end _x000D_...
K-Wire w. trocar/round end 1.57mm/152mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM711850·K-Wire w. trocar/round end
1.57mm...
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
IR Type Implant System
FDA 510(k)
FDA Class 2
·Dental
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 24, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 3, 2012
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 5, 2008
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021