FDA.report

Covidien LLC

Matched from indexed company URL: Covidien Llc

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12824971282497Covidien LLC1Y2026-01-0115 HAMPSHIRE STREET MANSFIELD MA US 02048
30049048113004904811Covidien llc1N2026-01-013062 Bunker Hill Lane Santa Clara CA US 95054
30049627883004962788Covidien llc1N2026-01-01161 CHESHIRE LANE SUITE 100 Plymouth MN US 55441

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
18061408559053K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSMSD1998-11-25
18061585193228K972992CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORSCCL1998-03-30
18061811864066K961856AUTO SUTURE CHEMOSITE TUNNELERLJS1996-07-18
18061901519758K953289TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGETDXZ1995-08-21
18061399541826K952748AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**LJT1995-08-10
18061512209294K952428POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTERCAH1995-07-07
18061877536726K950042SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETERFJS1995-12-15
18061895933989K943349MAHURKAR DUAL LUMEN CATHETERFOZ1995-03-22
1406471785600596K935198GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONSKNT1994-09-28
18061555976547K934382VCI SUCTION/IRRIGATION TUBING SETJOL1994-02-01
18061370985498K934132POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTERCAH1994-10-04
18061154498568K932647WIRE REINFORCED ENDOTRACHEAL TUBEBTR1993-11-02
1528491783792870K925392BIOPSY FORCEPSFCL1993-11-05
18062044752678K920515INSERTIONFJS1992-05-04
18061090747106K910787TITANIUM CONNECTOR (2 PART)FKO1991-08-15
18062012318789K910786TROCAR (FALLER STYLET)FJS1991-09-19
18061242390131K910785TITANIUM CATHETER EXTENDERFJS1991-08-22
18061196124542K896252MODIFIED QUINTON SINGLE LUMEN CATHETERMPB1990-01-29
18061986902865K890288PERITONEAL CATHETERS WITH AN ADDED FUNCTIONFJS1989-03-27
18061299345603K882097TUNNELING STYLETDRB1988-07-28
18061984841021K874633PERMCATH INSERTION TRAYLFJ1988-02-17
18061052308902K873727PULL-APART INTRODUCER (SHEATH)DYB1987-10-07
18061641440736K873394OVAL PULL-APART SHEATH/DILATORDYB1987-09-30
18061852145696K871942PERM-CATH CATHETER KITLFJ1987-06-17
18061218412888K871749ADULT PERM-CATH 40CM.LFJ1987-06-17
18061056947938K871730MODIFIED USE OF PULL-APART INTRODUCER SETFKO1987-05-18
18061056947938K871730MODIFIED USE OF PULL-APART INTRODUCER SETFKO1987-05-18
18061598080325K862288MODIFICATION OF TISSUE DILATORDRE1986-08-19
18061447367530K862046SWAN-NECK PERITONEAL DIALYSIS CATHETERSFJS1986-06-19
1528491489379631K860582TBI NEEDLEGAA1986-03-04
18061987495063K850214STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM INFJS1985-07-26
18061833103291K844692PEDIATRIC SIZED HEMOCATH CATHETERFIQ1985-01-18
18061438685231K844193QUINTON INJECTION SEALING CAPFOZ1985-05-17
18061552159944K840815LUER LOCKING ADAPTER(MATERIAL CHANGE)FOZ1984-11-08
18061813839703K840424HEMOCATH REPAIR KITKNZ1984-03-05
18061889341727K840415HEMOCATHFIQ1984-04-20
1528491300379463K834402GASTROINTESTINAL SHEATH BRUSHFDX1984-02-04
18061952535904K813488CATHETER REGULARFJS1981-12-31
18061008152824K780449BETA CAP SYSTEMFJS1978-05-16
18061550094368K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
1406471246430125K231861EndoflipTM 300 SystemFFX2023-07-21
18061832769088K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitFJS2022-01-14
1406471134842116K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorGEI2020-05-07
18061711492816K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterMPB2020-01-17
1528491894210663K191394ILLUMISITE PlatformJAK2019-08-07
1406471040148994K183072EndoFLIP SystemFFX2019-02-15
1406471154904276K181020Cytosponge Cell Collection DeviceEOX2018-08-16
18061602044401K180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter ExtenderFJS2018-07-27
1406471137190844K180037Beacon EUS Access SystemFCG2018-04-26
1406471284698696K173559Barrx SB RFA Endoscopic CatheterKNS2018-01-18
1528491385188248K173244superDimension Navigation System V7.2JAK2018-02-08
1406471519658526K172128EsoFLIP® ES-310 Balloon CatheterPIE2017-11-22
1406471647445140K171358Emprint SX Ablation Platform and AccessoriesNEY2017-09-01
1528491647445140K171358Emprint SX Ablation Platform and AccessoriesNEY2017-09-01
18061793941452K170635Chameleon PTA Balloon CatheterLIT2017-03-30
1528491237746089K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaEOQ2017-04-21
18061864572277K163231Chameleon PTA Balloon CatheterLIT2017-01-17
1406471177181982K162802Barrx Anorectal RFA WandGEI2017-01-24
18061259396588K161347Signia sterilization trayKCT2016-09-07
1406471505555243K160360Barrx FLEX RFA Energy GeneratorGEI2016-04-05
1406471449960090K152586Beacon Fine Needle Fiducial SystemNEU2015-12-30
1528491462870369K151376superDimension Navigation SystemJAK2015-11-05
1406471339003395K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemFCG2015-05-01
1406471401013736K150251Barrx Anorectal RFA WandGEI2015-07-28
1528491987446450K142934CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curvedEOQ2015-06-17
1528491904404964K142839GenCut Core Biopsy SystemEOQ2015-04-29
1406471303587264K142695Cytosponge Cell Collection DeviceEOX2014-11-26
1406472041984099K142364Barrx RFA Self Sizing Balloon CatheterGEI2014-10-01
1406471180631802K142000ESOFLIP ESPIE2014-09-25
1406471988011005K141894SHARKCORE FINE NEEDLE BIOPSY SYSTEMFCG2014-10-06
1406471987016322K140422HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEMGEI2014-06-05
1406471337357816K133821EMPRINT ABLATION SYSTEMNEY2014-04-28
1406471822749821K132337ESOFLIP BALLOON DILATION CATHETERPID2013-10-07
1406471482904400K130623BARRX CHANNEL RFA ENDOSCOPIC CATHETERKNS2013-07-26
18061435358248K130532IDRIVE ULTRA STERILIZATION TRAYKCT2013-05-30
1528491521218191K130357SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSHBTG2013-11-06
18061079131727K123196PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATHMSD2013-01-31
18061452493968K121904GYNECOLOGY STERILIZATION TRAYKCT2013-03-11
18061425594991K121848SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CMMSD2012-09-21
1528491902591145K120796SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKERJAK2012-10-26
18061304807069K120674MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETERMPB2012-04-04
1406471078748421K120431HALO90 ULTRA ABLATION CATHETERGEI2012-05-03
18061312228785K112477PALINDROME H, SI, HSI CHRONIC CATHETERNYU2011-09-28
1406471517674457K112454HALO60 ABLATION CATHETERGEI2012-01-05
18062065316182K111817PALINDROME RT CHRONIC CATHETERMSD2011-08-30
18061211892011K111372TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...MSD2011-08-04
1528491852260449K110093SUPERDIMENSION MARKER DELIVERY KITJAK2011-02-11
1406471448342441K103668BNX FINE NEEDLE ASPIRATION SYSTEMFCG2010-12-30
18061773426616K102605MAHURKAR TRIPLE LUMEN DIALYSIS CATHETERNIE2010-12-22
1528491230903113K102604I-LOGIC INREACH SYSTEMJAK2010-10-07
1528491253016318K100267FLEXIMARC, MODEL CM-0.9-2-10-GG-LIYE2010-02-24
1406471475827272K093855HALO 360 & SIZING BALLOON, MODEL 3441CGEI2010-01-15
1406471451330461K093008HALO ABLATION CATHETER, MODEL 90-9100GEI2010-01-08
18061246578720K092797ACUTE AND CHRONIC CATHETER REPAIR KITNFK2009-11-19
1406471411380379K092487HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230AGEI2009-11-10
1528491934345256K092365INREACH SYSTEM, MODEL AAS00161-02JAK2009-09-04
18061168131658K092205PALINDROME P HEMODIALYSIS CATHETERMSD2009-10-30
1406472010243005K083737HALO ABLATION CATHETERGEI2009-02-10
1406471866188847K083711MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34GEI2009-02-02
1528491138286038K082386INREACH PLANNING LAPTOPLLZ2008-09-16
18061949878952K082202HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230BGEI2008-10-08
18061303175139K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESKDD2008-04-16
18061153932599K071543HALO360' COAGULATION CATHETERGEI2007-06-29
18061529923229K062225HALO COAGULATION CATHETERGEI2006-08-28
18062065891410K051168BARRX HALO 360 SYSTEM, MODEL 1100C-115AGEI2005-06-29
18061752470000K042601CAPNOSTAT 5CCK2004-11-19
18061689625275K041006TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FRMSD2004-05-19
18061293310246K030209MAHURKAR OPLUS CATHETER, MODEL 13.5 FRMPB2003-05-13
18061949526249K020089MAHURKAR TRIPLE LUMEN CATHETER, 12 FRNIE2002-04-10
18061333836484K002902TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERSMSD2001-04-09
1406471545647350DEN220006ProdiGIQSW2022-06-13
180610069877821969-12-31
180610069877821969-12-31
180610069877821969-12-31
180610069877821969-12-31
180610256862221969-12-31
180610256862221969-12-31
180610256862221969-12-31
180610256862221969-12-31
180610955843771969-12-31

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GEI172020-05-07
FJS112022-01-14
MSD82013-01-31
JAK72019-08-07
MPB42020-01-17
FCG42018-04-26
NEY32017-09-01
EOQ32017-04-21
KCT32016-09-07
FOZ31995-03-22
FKO31991-08-15
LFJ31988-02-17
FFX22023-07-21
EOX22018-08-16
KNS22018-01-18
PIE22017-11-22
LIT22017-03-30
NIE22010-12-22
CAH21995-07-07
DYB21987-10-07
FIQ21985-01-18
QSW12022-06-13
NEU12015-12-30
BTG12013-11-06
PID12013-10-07
NYU12011-09-28
IYE12010-02-24
NFK12009-11-19
LLZ12008-09-16
KDD12008-04-16
CCK12004-11-19
CCL11998-03-30
LJS11996-07-18
DXZ11995-08-21
LJT11995-08-10
KNT11994-09-28
JOL11994-02-01
FCL11993-11-05
BTR11993-11-02
DRB11988-07-28

PMA

PMN

Applications

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