15 results · 21ms · Sources: EU EUDAMED, US FDA

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MINIMED PARADIGM INSULIN PUMP, MODEL 511

FDA 510(k)
FDA Class 2 ·General Hospital

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756836241·ANESTHESIA CIRCUIT

GATIFLOXACIN, 5 UG, BBL SENSI-DISC

FDA 510(k)
FDA Class 2 ·Microbiology

GEIGER NEEDLE ADAPTER, MODEL 406

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CARDIOSAVE HYBRID W/ E/F PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·April 17, 2025

IMPLANT HOLDER FOR

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code LXH·February 11, 2013

PROSTAR XL SUTURE-MEDIATED CLOSURE

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·February 25, 2011

BREMER SKULL PIN

FDA Adverse Event
Injury ·DEPUY SPINE, INC.·Product code HBL·February 25, 2008

UNO URO/ISC

FDA Adverse Event
Malfunction ·UNOMEDICAL S.R.O.·Product code GBM·September 30, 2022

UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM

FDA Adverse Event
Injury ·COVIDIEN LLC·Product code GWM·October 18, 2022

UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM

FDA Adverse Event
Malfunction ·COVIDIEN LLC·Product code GWM·October 18, 2022

Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090

FDA Enforcement
Class II ·Ongoing·Scientia Vascular, Inc.·March 22, 2023

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

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

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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