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