20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517636959·CoRoent Ant TLIF PEEK, 13x11x30mm 15°
COE-FLEX®
FDA UDI
Gc America Inc.·D6581313051·COE-FLEX® s Regular Body, Fast Set (catalyst on...
COE-FLEX®
FDA UDI
Gc America Inc.·10386040004954·COE-FLEX® s Regular Body, Fast Set (catalyst on...
Ambler Value Line
FDA UDI
AMBLER SURGICAL CORP.·00190660204372·Jansen-Middleton nasal septum forceps, 7 3/4'',...
OLYMPUS ULTRASONIC SURGICAL SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·January 28, 2020
STOCKERT 70 RF GENERATOR
FDA Adverse Event
Malfunction
·STOCKERT GMBH·Product code DRF·January 10, 2014
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 8, 2019
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code MTD·August 25, 2015
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES·Product code FTL·May 17, 2013
DIAMOND 3
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DXY·June 16, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 1, 2014
PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DYB·June 14, 2013
THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 9, 2015
LASSO® 2515 NAV ECO VARIABLE CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 14, 2013
HALO¿ XP ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·May 21, 2015
Depuy P.F.C. E Knee System, stabilized plus tibial insert; polyethylene tibial insert, Sz 4, 30 mm; Ref 96-2747.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015