11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021253·INTRG WHISP ROTH 1BIC HK-17T 0A 022 LR
Sklar®
FDA UDI
SKLAR CORPORATION·10649111148156·SKLIT XD STEVENS CVD BB 4.5
Brisbane ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215018221·
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
ENTERRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LNQ·November 12, 2008
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·July 18, 2011
SUMMIT POR TAPER SZ5 STD OFF
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code LPH·July 17, 2013
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015