13 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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Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003333·Diagnostic EP Catheter, Cournand curve, 4 elect...
ELMED
FDA UDI
ELMED INCORPORATED·00842180103009·BIPOLAR RF-CABLE FOR ELMED TRIPLE FUNCTION FORC...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016155·Trocar, Long Pointed
MAEDA NEW NEEDLE DISPOSABLE
FDA 510(k)
FDA Class 2
·General Hospital
COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
MAXIMO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 1, 2013
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024
MECTALIF TRANSFORAMINAL CAGES TIPEEK
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014