12 results · 29ms · Sources: EU EUDAMED, US FDA

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BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

JOBST SensiFoot

FDA UDI
BSN MEDICAL, INC.·00035664108793·SENSIFOOT 8-15 MM HG MINI CREW EXTRA LARGE WHIT...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306805813·Jordan-Richardson-Simpson Retractor, 1inx1.25in

UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

CONTRALCO

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·March 4, 2022

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Death ·CORDIS LLC (PR)·Product code NIQ·May 14, 2013

ACCU-CHEK ® COMPACT PLUS TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 23, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 2, 2011

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024