16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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