15 results · 19ms · Sources: EU EUDAMED, US FDA

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STAR

FDA 510(k)
FDA Class 2 ·Radiology

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209137725·

ACUMED

FDA UDI
Acumed LLC·10806378052408·Forearm Hexalobe Screw Caddy

Raw Surgical Corporation

FDA UDI
RAW SURGICAL CORPORATION·G508RSC08019170·LILEHEI-POTTS TENOTOMY SCISSORS, Straight, Over...

PARODI CATHETER FOR ANGIOGRAPHY (PARCA)

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

COBAS E 411 ANALYZER (RACK SYSTEM)

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 5, 2025

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 28, 2025

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 9, 2014

TURBO ELITE LASER ABLATION CATHETER

FDA Adverse Event
Injury ·SPECTRANETICS CORPORATION·Product code MCW·October 23, 2012

MAGIC 3 FEMALE INTERMITTENT CATHETER

FDA Adverse Event
Malfunction ·ROCHESTER MEDICAL CORP·Product code KOD·May 27, 2015

COBAS E 411 ANALYZER (RACK SYSTEM)

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 27, 2025

HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

FDA Enforcement
Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024