18 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
FDA 510(k)
FDA Class 2
·General Hospital
TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·January 18, 2017
TURBO-JECT POWER INJECTABLE
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·July 3, 2018
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·August 24, 2017
1820334-2020-01805
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 5, 2020
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·June 28, 2018
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450160053·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112440·Awl Tap, 6.5 mm, Fixed Sleeve
SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
FDA 510(k)
FDA Class 2
·General Hospital
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code OTP·May 8, 2013
KINETIX PTCA GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018