18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
Bur PM2-70 80K Acorn Ø9.2 St
FDA UDI
Bien-Air Surgery SA·17630055512656·
Oticon
FDA UDI
Oticon A/S·05707131164001·ACTO, BTE 13 STG
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331186684·mayo vein stripper, 15 3/8" (39.0 cm), 7.2 mm i...
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED, LLC·Product code HRS·July 14, 2025
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED, LLC·Product code HRS·July 14, 2025
VIGIL DNASE B CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UMECO OPTIMA MULTILINE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYRINGE 0.3ML 31G 6MM S/C U-100 RELION
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949·Product code FMF·February 28, 2024
RELION INSULINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 7, 2023
MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS-14 FR PULL
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KNT·June 17, 2021
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
UNKNOWN·Product code IOR·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 19, 2014
EPIDURAL CATHETERIZATION KIT
FDA Adverse Event
Injury
·ARROW INTERNATIONAL INC.·Product code CAZ·May 18, 2011
MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 14 FR
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code KNT·April 22, 2021
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
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