18 results
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35ms
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Sources: EU EUDAMED, US FDA
K.E.P. CONNECTOR AND CLIP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bard® Heyman™ Slipover Catheter Stylet
FDA UDI
C. R. Bard, Inc.·00801741045738·Bard® Heyman™ Slipover Catheter Stylet
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702466836·Elvarex 3/Knee High/Slant-Closed Toe/Dotted Sil...
JOBST Elvarex Soft
FDA UDI
BSN-Jobst GmbH·04059993363711·ELVAREX SOFT 2/KNEE HIGH/SLANT-OPEN TOE/DOTTED ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702265644·Elvarex 2/Knee High/Closed Toe/Dotted 5 cm Sili...
3-Lead Leadset,Inf,AHA,Snap
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904004723·
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
FDA 510(k)
FDA Class 1
·Dental
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 2, 2019
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
UNSPECIFIED SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 4, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 30, 2011
CONTAK RENEWAL 3 RF HE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 27, 2020
Clarke-Reich Laparoscopic Knot Pusher
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 21, 2017
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 21, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
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