18 results · 20ms · Sources: EU EUDAMED, US FDA

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LLOYD LINDEN, MODEL E04

FDA 510(k)
FDA Class 2 ·Physical Medicine

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496071761·STRIPE GAME MERIDIAN, SIZE S, BLU CINA, GRADUAT...

I-neb

FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730003702·I-neb 5.0 mcg Gold Chamber, 2 pack.

STATLYTE NA/K/CL/LI ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT

FDA 510(k)
FDA Class 2 ·Cardiovascular

PF4 IGG

FDA Adverse Event
Malfunction ·IMMUCOR GTI DIAGNOSTICS·Product code GWG·January 16, 2015

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 30, 2025

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·December 22, 2008

SPECTRA WAVEWRITER?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 4, 2025

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·April 27, 2009

PRECISION®

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 22, 2013

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·April 28, 2011

HIP

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code JDI·July 3, 2008

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·March 3, 2011

ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

FDA Enforcement
Class II ·Terminated·Arrow International Inc·June 14, 2017

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

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025