FDA.reportPublic FDA data

BioClinica, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
11262711000263641BioClinica, Inc.1N2026-01-011818 Market Street Philadelphia PA US 19103

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
769041919396307K973403CARDIOSMART STLOS1998-03-12
769041069303417K920626MODEL ELI 200 ELECTROCARDIOGRAPHLOS1992-09-04
769041202599285K913523AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITORDXN1991-11-06
769041127065323K855127AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202DXN1986-08-14
769041333102638K213436Clarius Ultrasound ScannerIYN2021-11-15
769041508260884K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorDXN2020-06-18
769042064564015K183072EndoFLIP SystemFFX2019-02-15
769041964631381K173895Tel-O-GraphDXN2019-05-16
769041509930962K163235HEM-9210TDXN2017-04-20
769041119150600K162137Fever Scout™ Continuous Monitoring thermometerFLL2017-01-19
769041688812153K122073ELI 280 ELECTROCARDIOGRAPHDPS2012-08-02
769041121402730K110603HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)DXN2011-12-16
769042016378968K103732SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITORDXN2011-02-04
769041521183577K101403ELI 250 ELECTROCARDIOGRAPHDPS2010-07-02
769041808681064K101275MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS).DXN2010-05-28
769041070943038K101115ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150DPS2010-06-18
769041270401709K082881MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3DXN2008-11-24
769041615218467K073198MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1)DXN2008-01-11
769041924134508K070750247 BP DEVICEDXN2007-05-02
769041937239866K060315HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEMDXN2006-04-07
769041035430510K051730MATRIX HOLTER SYSTEM, MODEL M12MLO2005-09-26
769041884938994K051546BPCALIBRATOR MC3000/MC3100DXN2005-06-24
769041174020355K043217A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITORDXN2005-03-03
769041455253305K041313STABIL-O-GRAPHDXN2004-06-18
769041654442232K040410GREENLIGHT 300DXN2004-05-05
769041468812783K032305OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XLDXN2004-02-11
769041937526883K023055BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200DXN2002-10-22
769041604548069K021373H12+HOLTER RECORDERMWJ2002-06-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN202020-06-18
DPS52012-08-02
LOS31998-03-12
MLO22005-09-26
MWJ22002-06-27
IYN12021-11-15
FFX12019-02-15
FLL12017-01-19