FDA.reportPublic FDA data

LivaNova USA, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16444871000117004LivaNova USA, Inc.1N2026-01-01100 CYBERONICS BLVD. HOUSTON TX US 77058
17188501718850LivaNova USA, INC.1Y2026-01-0114401 WEST 65TH WAY ARVADA CO US 80004

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
438201913223744P970003VNS THERAPY SYSTEMLYJ1997-07-16
444971094950969K993818ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINEDWF2000-02-08
444971278864403K991986COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTIONCAC1999-09-09
444971794607004K982891CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDSDTS1998-09-30
444971989757622K982406COBE VACUUM RELIEF CHECK VALVEMJJ1998-10-07
444971957027934K981613COBE SMARXT TUBING AND CONNECTORSDWE1998-10-26
444971706313106K973139ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTORGCJ1997-11-13
444971864684430K962070YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBEFLL1996-07-19
444971703440498K955120HAND-HELD RETRACTOR, DISSECTOR & DISSECTORGCM1996-01-26
444971795960847K940936AESCULAP ENDOSCOPIC INSTRUMENTSGEI1994-04-19
444971232932141K920312NEW COBE CARDIOPLEGIA SYSTEMDTN1992-10-01
444971740794451K912019ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEMCAC1991-10-08
444971745885117K900753SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)DWF1990-04-10
444971876286346K882414BLOOD RESERVOIR, CARDIOPULMONARY BYPASSDTN1988-12-05
444971796578973K881330COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACKDWF1988-06-10
444971927886227K854640MODIFIED CORONARY CARDIOPLEGIA ADAPTORDWF1986-02-10
444971388991689K833322TUBING CONNECTORS EC-2XXX SERIESDTL1983-12-16
444971561720112K800717TOPICAL COOLING DEV. TCD. #27-999DTR1980-04-16
444971424387141K792134BONCHEK-SHILEY VEIN DISTENTION SYSTEMDWP1979-12-04
444971237277350K781990CARDIAC INSULATION PADDWF1978-12-04
444971615788188K233702SMARxT Tubing and ConnectorsDWE2024-08-08
444971731974843K122735SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2GAT2013-05-21
444971284119403K102983VASCUCLEAR PRECISION BIPOLARGEI2010-11-01
438201113162512K092364MODEL 220 PATIENT MAGNETDTG2009-11-03
444971485719339K091542ESTECH EASYFLOW CANNULA WITH GUIDEWIREDWF2009-10-20
444971997348203K070749ESTECH PERCUTANEOUS INSERTION DILATOR KITDRE2007-10-24
444971732553752K060101ESTECH AORTIC EASY FLOW CANNULADWF2006-05-10
444971411557485K052081REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULADWF2005-12-16
444971315857376K030231CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOONDWF2003-04-18
444971820917614K000830CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBEDWF2000-09-07
438201720933748
444971011260698
444971217198357
444971286332762
444971309915609
444971315857376
444971332510001
444971359283752
444971389317296
444971459267014
444971466364832
444971479435106
444971496883459
444971547901873
444971632376122
444971647110416
444971664652833
444971677156080
444971739167902
444971789383839
444971813465344
444971831032230
444971877947460
444971893558003
444971934994769
444971974044078
444972046731050
444972049540959
444972073585035

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWF102009-10-20
DWE22024-08-08
GEI22010-11-01
DTG22009-11-03
CAC21999-09-09
LYJ21997-07-16
DTN21992-10-01
GAT12013-05-21
DRE12007-10-24
MJJ11998-10-07
DTS11998-09-30
GCJ11997-11-13
FLL11996-07-19
GCM11996-01-26
DTL11983-12-16
DTR11980-04-16
DWP11979-12-04

PMA#

200 records. Showing 1-40. Next

PMN#

GUDID#

200 records. Showing 1-40. Next