19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
2130 3 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00874750009343·2130A 3W STPCK .187FB 7.5MMOD
SPIDER FLEX MONOPOLAR HOOK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TERUMO 30 GAUGE HYPODERMIC NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·February 24, 2014
EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·November 12, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 19, 2011
PROXIMATE PPH PROCEDURE SET
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 11, 2008
NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·July 19, 2016
NIM® 3.0 MAINFRAME
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015
NIM® 3.0 MAINFRAME
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ETN·August 15, 2016
NIM® PROBE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2018
NIM® PROBE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·May 11, 2015
MPACT DM CONVERTER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 21, 2025
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
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