FDA.reportPublic FDA data

Synergy Health AST, SRL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30077387363007738736Synergy Health AST, SRL1N2026-01-01B16 Street 4, Avenue 0 Coyol Free Zone Alajuela CR 20102

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1004191059634468P120006OVATION ABDOMINAL STENT GRAFT SYSTEMMIH2012-10-05
1004191975918279K992581ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDSGEI1999-12-09
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
1004191321528147K963000MAXI LD PTA BALLOON CATHETERLIT1997-02-20
1004191661040793K961225CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETFPA1996-06-21
1004191455186426K931962NON-ABSORBABLE GAUZEGCJ1993-12-10
1004191935148810K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONKRA1990-01-19
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
1004192052184576K161125OptiCross X, 40 MHz Coronary Imaging CatheterOBJ2016-05-19
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
1004191331166303K142011SOLUTION SET/EXTENSION SETFPA2014-08-18
1004191256706255K140576Y WIRE 2HXI2014-05-20
1004191933884795K133843SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETERLIT2014-06-27
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
1004192004412982K123621OPTICROSS 40 MHZ CORONARY IMAGING CATHETEROBJ2013-04-15
1004192033950847K123353CIQ CONTROLLER, CIQ WANDSGEI2013-04-05
1004191544550432K122652ARTHROCARE TURBINATOR WANDGEI2013-07-02
1004191631912381K121785SCEPTER C OCCLUSION BALLOON CATHETERMJN2012-08-10
1004191580271469K121442POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERLIT2012-06-14
1004191223635074K120908HYDROCOIL EMBOLIC SYSTEM (HES)HCG2012-04-25
1004191174651138K112893CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETSFPA2011-10-18
1004191760985008K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERLIT2012-05-04
1004191239178422K112226HYDROCOIL EMBOLIC SYSTEM (HES)HCG2011-09-29
1004191463152532K112181HYDROCOIL(R) EMBOLIC SYSTEM (HES)HCG2011-12-01
1004192020863312K100353SPINEWAND SURGICAL DEVICEGEI2010-05-13
1004191405482146K091825HI-TORQUE PROGRESS GUIDE WIRE FAMILYDQX2009-09-25
1004191101108967K091228SPINEWAND SURGICAL DEVICEGEI2009-09-28
1004191652802085K090001V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503HCG2009-03-05
1004191631675461K082323ARTHROCARE ARTHROWANDSGEI2008-08-28
1004191788041774K080282ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;GEI2008-02-15
1004191361836612K071709ARTHROCARE SYSTEM 12000GEI2007-08-07
1004191629138569K071189CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETERLIT2007-05-16
1004191650500294K070374ARTHROCARE ENT PLASMA WANDGEI2007-04-25
1004191671897437K070227OPUS MAGNUM PI KNOTLESS FIXATION DEVICEMBI2007-04-16
1004191704518062K063172ARTHROCARE CAVITY SPINEWANDGEI2007-04-27
1004191437682740K061349OPUS LABRALOCK P KNOTLESS FIXATION DEVICEMBI2006-07-14
1004192056875373K053567ATHROCARE TOPAZ ARTHROWANDSHRX2006-03-06
1004191656834377K053447ARTHROCARE PERC-D SPINEWANDGEI2005-12-27
1004191122226858K040413CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEMFGE2004-06-21
1004191124345136K033394CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEMFGE2003-12-22
1004191100848029K032737CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTADQY2003-10-02
1004191241203678K031937ALANTECH GRAFT FIXATION SCREWHWC2003-09-04
1004191669384627K030954ARTHROCARE PERCD SPINEWANDGEI2003-04-16
1004191086416319K030549HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHGDQX2003-05-14
1004191323453307K023907CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETERKNQ2002-12-18
1004191381617021K022735MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KITHCG2002-09-06
1004191744502897K021914MICROPLEX COIL SYSTEMS (MCS)HCG2002-07-09
1004191808646968K020621ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSGEY2002-03-28
1004191987089170K020434MICROPLEX COIL SYSTEM (MCS)HCG2002-07-29
1004191317337550K013833HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096DQX2002-01-16
1004191691732629K012056CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEMFGE2001-08-01
1004191721333477K011905SNIPER ELITE MODEL-OR-E3872XX SERIESDQX2001-08-28
1004191247371636K010811PERC-D SPINEWANDHRX2001-05-30
1004191920006179K003159CORDIS SLALOM PTA BALLOON CATHETERLIT2000-10-30
1004192051908301K002206HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRODQX2000-08-24
1004191697714187H130005
1004191302003006BK160028
1004192040399593BK080033
1004191853985937
1004191900773640
1004191996059192
1004191022833299
1004191023492765
1004191038167587
1004191059620039
1004191059634468
1004191062689879
1004191063181919
1004191069021524
1004191069880232
1004191071674888
1004191073040678
1004191077824039
1004191079212908
1004191083985961
1004191093913921
1004191097095661
1004191098581120
1004191101103932
1004191114094636
1004191120426550
1004191125230511
1004191131768195
1004191154820409
1004191162476622
1004191163892535
1004191168310510
1004191175440790
1004191198988265
1004191204792279
1004191206215711
1004191219707342
1004191220785844
1004191232697645
1004191239178422
1004191246967933
1004191247783805
1004191275848672
1004191276006758
1004191281813605
1004191289118579
1004191294755541
1004191305009818
1004191309440005
1004191313888700
1004191316045098
1004191338811016
1004191340754842
1004191363774242
1004191397100530
1004191403336278
1004191409214417
1004191413795485
1004191419505066

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI132013-08-09
LIT72014-06-27
HCG72012-04-25
DQX62009-09-25
FPA52015-12-28
OBJ42016-06-22
KRA32018-11-08
FGE32004-06-21
MBI22007-04-16
HRX22006-03-06
DXO12017-10-23
HXI12014-05-20
MIH12012-10-05
MJN12012-08-10
DQY12003-10-02
HWC12003-09-04
KNQ12002-12-18
GEY12002-03-28
GCJ11993-12-10