13 results · 24ms · Sources: EU EUDAMED, 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