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

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LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER

FDA 510(k)
FDA Class 2 ·Microbiology

NA

FDA UDI
Smith & Nephew, Inc.·03596010038623·BONE CURETTE STRAIGHT 228.6MM X ...

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089444601·

DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN

FDA 510(k)
FDA Class 2 ·General Hospital

NEUROTHERM, MODEL JK4

FDA 510(k)
FDA Class 2 ·Neurology

GMK FIXED PS LINER SIZE 4 / 14MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·August 30, 2012

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·May 9, 2013

PINNACLE MTL INS NEUT36IDX58OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 23, 2014

ASR UNI FEMORAL IMPL SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

MEDFUSION 3500 SYRINGE INFUSION PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·July 9, 2022

PENUMA IMPLANT

FDA Adverse Event
Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.

FDA Enforcement
Class II ·Terminated·Smith & Nephew, Inc.·February 17, 2016

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025