16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONTROL PLASMA N, PROC CONTROL PLASMA
FDA 510(k)
FDA Class 2
·Hematology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673198·LEVAMED STABILI-TRI ANK SUP BLU R III
STb SST
FDA UDI
ORMCO CORPORATION·00889989025156·STb STRAIGHTWIRE SST 17 x 17 LG PK10
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809872248·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXI-SITE SP02 EAR SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
OCTRODE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 15, 2011
VITALITY AVT FAST-CHARGE
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
VNGD SSK 360 FEMUR R 67.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 10, 2020
BMT SPLINED KNEE STM V2 12X80
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 10, 2020
BMT 360 TIB 5.0 OFFSET ADAPTER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 10, 2020
ANKLE FUSION PLATE, LATERAL TTC
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·July 22, 2020
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018