26 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MyPAO Planning Report
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003449·Diagnostic EP Catheter, Cournand curve, 4 elect...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016216·Modular Cannula, Mandible
DUVAL COLLIN FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896084896·DUVAL COLLIN FORCEPS HORIZONTAL SERRATED TIPS
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
FDA 510(k)
FDA Class 2
·General Hospital
MODEL 445SI-64E QUADRATURE WRIST COIL
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 1, 2013
bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024
PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP.
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code GWM·October 6, 2017
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·September 26, 2024
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 30, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·December 6, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·November 5, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 26, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·November 13, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 31, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 6, 2024