FDA.reportPublic FDA data

Synergy Health AST, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20305981000518731Synergy Health AST, LLC1N2026-01-019020 Activity Rd Ste D SAN DIEGO CA US 92126
30077387363007738736Synergy Health AST, SRL1N2026-01-01B16 Street 4, Avenue 0 Coyol Free Zone Alajuela CR 20102
30098824643009882464Synergy Health AST, LLC1N2026-01-017225 N Noah Dr Saxonburg PA US 16056
30121024373012102437Synergy Health AST, LLC1N2026-01-013200 Lakeville Hwy Suite 120 Petaluma CA US 94954

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1004191059634468P120006OVATION ABDOMINAL STENT GRAFT SYSTEMMIH2012-10-05
1472861355964291P040044MATRIX VASCULAR CLOSURE SYSTEM (VSG)MGB2005-08-17
1472862031396784K994243DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIPDWF2000-05-05
1004191975918279K992581ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDSGEI1999-12-09
1473291444330816K992363SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THINFRO1999-08-12
1472862005282635K991059SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017DQY1999-11-16
1875582005282635K991059SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017DQY1999-11-16
1472861380216516K983559BLOOD TUBING ACCESSORY WITH CLAVE CONNECTORFJK1998-12-24
1004191019954894K982083ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATINGDQX1998-09-11
1004191797955713K981407OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETERLIT1998-05-20
1472861695030578K974589SMARTVALVEFPA1998-01-09
1472861434783445K973167POSITIVE PRESSURE CONNECTORFPA1997-11-17
1472861938952279K970855CLAVE CONNECTORFPA1997-06-24
1472861154820409K964435PRIMARY IV SETFMG1997-04-02
1004191321528147K963000MAXI LD PTA BALLOON CATHETERLIT1997-02-20
1004191661040793K961225CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETFPA1996-06-21
1472861484111017K954813ICU EXTENSION KITFPA1995-11-29
1472861262220336K953573ICU STOPCOK WITH EXTENSION TUBINGFMG1995-10-07
1472861548036384K942329HAND CONTROLLED SYRINGEDQO1994-06-20
1472861180403718K941190CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SETFPA1995-01-31
1472861276914368K940296SAFE CONNECTORFPA1994-02-22
1472861232905814K934591CLAVE VIAL ACCESS SPIKEFMI1994-02-16
1472861124613923K934561ONE TIME VIAL ACCESS SPIKEFMF1994-02-10
1473291212681643K934086MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGEDXT1995-06-15
1472861058042972K932188SAFESET RESERVOIRKRA1993-10-25
1004191455186426K931962NON-ABSORBABLE GAUZEGCJ1993-12-10
1472861953922563K915571CLAVE CONNECTORFPA1992-09-21
1472861553454305K915171LOPEZ VALVE TM IIKNT1992-02-07
1473291377445642K915118PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBEHQC1991-12-27
1875581355341069K912780MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELDGEI1991-12-30
1472861137842078K910546PIGGY LOCK NEEDLE HOUSINGFPA1991-04-29
1004191935148810K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONKRA1990-01-19
1473291138460557K861182TIMELINE VENIPUNCTURE SYSTEMFPA1986-06-04
1875581292453461K821897LENSKYG1983-01-05
1004191410283904K181684VAMP Plus Venous/Arterial Blood Management Protection SystemKRA2018-11-08
1004191382365803K173586VAMP Venous/Arterial Blood Management Protection SystemKRA2018-04-05
1004191834512153K171996TruWave Disposable Pressure TransducerDXO2017-10-23
1472862023100803K170819AcQMap 3D Imaging and Mapping CatheterMTD2017-10-16
1473291698515340K162554Gentrix Surgical MatrixFTM2016-10-21
1004192052184576K161125OptiCross X, 40 MHz Coronary Imaging CatheterOBJ2016-05-19
1472862052184576K161125OptiCross X, 40 MHz Coronary Imaging CatheterOBJ2016-05-19
1473292031468130K160715AccuLIF TL and PL CageMAX2016-07-08
1004191458768994K160514OptiCross 18, 30 MHz Peripheral Imaging CatheterOBJ2016-06-22
1004191990960466K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)OBJ2016-02-25
1004191482024179K153158Solution Administration Sets with 0.2 Micron FilterFPA2015-12-28
1472861843913396K152070BioZorb LP MarkerNEU2015-08-26
1875581529306141K150607Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2mlNDN2015-04-09
1875581168054395K150319MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMSHCG2015-06-12
1472861241921328K143484BioZorb MarkerNEU2015-06-29
1472861258552772K142712Dental Collagen Wound Dressing (Nova Tape and NovaPlug)KGN2015-01-08
1875581778692006K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector CableHCG2014-12-24
1004191331166303K142011SOLUTION SET/EXTENSION SETFPA2014-08-18
1875581841979350K141930OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2MLNDN2014-08-21
1473291141338010K141704NOVASHIELD INJECTABLE NASAL PACKING AND STENTLYA2014-10-06
1473291004376066K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixFTM2015-06-17
1472861528431432K140946NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITEMQV2014-08-22
1875581618185733K140937OSSEOFLEX SBNDN2014-06-19
1004191256706255K140576Y WIRE 2HXI2014-05-20
1472861369166251K140367ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIXKGN2014-09-12
1004191933884795K133843SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETERLIT2014-06-27
1472861089822463K132420WINGMAN EXTENDABLE TIP SUPPORT CATHETERDQY2013-09-19
1875581315657035K132281ReVive PV (Peripheral Vasculature) Thrombectomy DeviceQEW2013-08-30
1472861267777669K132105PERCLOT TOPICALQSY2014-04-03
1472861492655960K131549CHEMOLOCK, CHEMOLOCK PORTONB2013-07-26
1004191699851487K131205ARTHROCARE HEAD AND NECK COBLATION WANDGEI2013-08-09
1004191804711738K123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SETFPA2013-01-08
1473291072413366K123756COVAGENKGN2013-08-16
1473291292176647K123733CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEMOCL2013-04-01
1004192004412982K123621OPTICROSS 40 MHZ CORONARY IMAGING CATHETEROBJ2013-04-15
1472862004412982K123621OPTICROSS 40 MHZ CORONARY IMAGING CATHETEROBJ2013-04-15
1472861887658294K123424MDU5 PLUS STERILE BAGITX2013-02-20
1004192033950847K123353CIQ CONTROLLER, CIQ WANDSGEI2013-04-05
1004191544550432K122652ARTHROCARE TURBINATOR WANDGEI2013-07-02
1875581296924268K122580AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIESGEI2012-11-09
1875581903617908K122533OSSEOFLEX SB INFLATABLE BONE TAMPNDN2012-10-23
1472861046390275K122502BRIDGE EXTRACELLULAR COLLEGEN MATRIXKGN2013-02-26
1472861950906192K122316AZUR DETACHABLE 35KRD2012-08-29
1472861306302532K121931NONDISPOSABLE STIMULATING INSTRUMENTSETN2012-10-19
1004191631912381K121785SCEPTER C OCCLUSION BALLOON CATHETERMJN2012-08-10
1004191580271469K121442POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERLIT2012-06-14
1472861894981498K121186RADIAL JAW 4 PULMONARY BIOPSY FORCEPSBWH2012-05-16
1004191223635074K120908HYDROCOIL EMBOLIC SYSTEM (HES)HCG2012-04-25
1472861094623081K120841APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHORMBI2012-06-07
1875581948117900K120821LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEMOCT2012-05-11
1875581008548195K120686ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEMHCG2012-04-04
1472861914283144K120630AZUR DETACHABLE 18KRD2012-03-28
1875581300743104K120274DELTAMAXX 18 MICROCOIL SYSTEMHCG2012-03-02
1472862056788548K120178WINGMAN EXTENDABLE TIP SUPPORT CATHETERDQY2012-02-08
1473291314770873K113316DCS LACRIMAL STENTOKS2012-11-08
1472861732520964K113079SYNTHES HEMOSTATIC BONE PUTTYMTJ2011-12-13
1004191174651138K112893CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETSFPA2011-10-18
1004191760985008K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERLIT2012-05-04
1473291890567903K112409MATRISTEM WOUND MATRIXKGN2011-08-29
1004191239178422K112226HYDROCOIL EMBOLIC SYSTEM (HES)HCG2011-09-29
1472861239178422K112226HYDROCOIL EMBOLIC SYSTEM (HES)HCG2011-09-29
1004191463152532K112181HYDROCOIL(R) EMBOLIC SYSTEM (HES)HCG2011-12-01
1472861563681679K111838INQU PASTE MIXMQV2011-09-26
1472861232697645K111451MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XXHCG2011-09-20
1472861101103932K111307AZUR DETACHABLE 35 PLATINUM COIL SYSTEMKRD2011-06-15
1473291831133254K110306SOUND SURGICAL VASER 2.1 LIPO SYSTEMQPB2011-06-23
1472861006483904K110140NEUROVISION NERVE LOCATOR MONITORGWF2011-09-30
1473291674987988K103787MEDEOR MATRIXFTM2011-02-07
1472861247783805K103758MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10HCG2011-04-28
1472862037258848K102365MICROPLEX COIL SYSTEM- COSMOSKRD2010-11-18
1472861584854038K101657RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40KGE2010-10-05
1875581949095237K101453VITALA NATURAL RESORBABLE COLLAGEN MEMBRANENPL2011-07-21
1472861302099495K100576HIGH PRESSURE SETS-400 PSIFPA2010-12-17
1472861664479582K100434CLAVE NEUTRONFPA2010-07-09
1004192020863312K100353SPINEWAND SURGICAL DEVICEGEI2010-05-13
1472861063181919K093919MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VHCG2010-01-21
1472861396077110K093730PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)DWF2010-01-14
1472861862650476K093358MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-VHCG2010-01-15
1472861198988265K093002AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610KRD2009-10-28
1473291078035357K092926ACELL MATRISTEM WOUND SHEETKGN2009-10-28
1472861665994173K092822CAPRI APPLICATORJAQ2009-11-03
1004191405482146K091825HI-TORQUE PROGRESS GUIDE WIRE FAMILYDQX2009-09-25
1472861069880232K091641HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)HCG2009-06-30
1473291237194079K091499MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)FTM2009-10-22
1004191101108967K091228SPINEWAND SURGICAL DEVICEGEI2009-09-28
1875581657080492K091074AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIESGEI2009-08-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA262015-12-28
HCG262015-06-12
GEI162013-08-09
KGN82015-01-08
MQV72014-08-22
LIT72014-06-27
FTM62016-10-21
OBJ62016-06-22
KRD62012-08-29
DQX62009-09-25
FRO62008-09-19
DQY52013-09-19
KRA42018-11-08
NDN42015-04-09
FMG42009-02-25
FMF42008-05-02
FTL42008-04-03
MBI32012-06-07
FGE32004-06-21
NEU22015-08-26
DWF22010-01-14
DXT22009-01-12
DQO22006-11-30
QEZ22006-03-09
HRX22006-03-06
DXO12017-10-23
MTD12017-10-16
PUM12017-06-01
MAX12016-07-08
LYA12014-10-06
HXI12014-05-20
QSY12014-04-03
QEW12013-08-30
ONB12013-07-26
OCL12013-04-01
ITX12013-02-20
OKS12012-11-08
ETN12012-10-19
MIH12012-10-05
MJN12012-08-10