FDA.reportPublic FDA data

Covidien

Matched from indexed company URL: Covidien LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12199301219930Covidien1N2026-01-0160 Middletown Ave North Haven CT US 06473
12824971282497Covidien LLC1Y2026-01-0115 HAMPSHIRE STREET MANSFIELD MA US 02048
17173441717344Covidien1N2026-01-016044 Longbow Court BOULDER CO US 80301
20245002024500COVIDIEN1N2026-01-012101 Faraday Avenue CARLSBAD CA US 92008
26475802647580Covidien1N2026-01-01BUILDING 911-67 SABANETAS INDUSTRIAL PARK PONCE PR US 00731
29369992936999Covidien1N2026-01-01200 Medtronic Dr Lafayette CO US 80026
30049048113004904811Covidien llc1N2026-01-013062 Bunker Hill Lane Santa Clara CA US 95054
30049627883004962788Covidien llc1N2026-01-01161 CHESHIRE LANE SUITE 100 Plymouth MN US 55441
30083614983008361498Covidien1N2026-01-012800 Airwest Blvd, Suite 160 Plainfield IN US 46168
30266124813026612481Covidien1N2026-01-01200 Medtronic Drive Lafayette CO US 80026
10671653003289066Covidien Sales LLC formally Tyco Healthcare1Y2020-04-25110 KENDALL PARK LN. Atlanta GA US 30336
14246433003473206Covidien1N2020-04-25815 Tek Dr CRYSTAL LAKE IL US 60014
30064006303008280586COVIDIEN1N2020-04-256135 Gunbarrel Avenue Boulder CO US 80301
30143666223014366622Covidien1N2020-04-2512 Gill Street, Suite 3500 Woburn MA US 01801

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10884521091986Nellcor - Adult SpO2 Sensor Non-Adhesive;OxiMax (TM) Technology+1(508)261-8000covidien.udi@covidien.com
20884521841687Shiley - Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Distal with Disposable Inner Cannula+1(508)261-8000covidien.udi@covidien.com
20884521841694Shiley - Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Distal with Disposable Inner Cannula+1(508)261-8000covidien.udi@covidien.com
20884521841700Shiley - Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Distal with Disposable Inner Cannula+1(508)261-8000covidien.udi@covidien.com
20884521841717Shiley - Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Distal with Disposable Inner Cannula+1(508)261-8000covidien.udi@covidien.com
20884521841724Shiley - Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Proximal with Disposable Inner Cannula+1(508)261-8000covidien.udi@covidien.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
17911810648198P110023EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)NIP2012-03-07
17911923779532P060001PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMSNIM2007-01-24
17911143818966P030045INTRASTENT DOUBLESTRUT STENTNIO2004-06-08
17911211864939P010002INDERMIL(TM) TISSUE ADHESIVEMPN2002-05-22
17911456206063K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODEGEI2000-03-07
18221456206063K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODEGEI2000-03-07
3152101456206063K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODEGEI2000-03-07
17881180842907K993637N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMSDQA1999-11-24
17881540653818K993268MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUITBTT2000-04-19
17891540653818K993268MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUITBTT2000-04-19
17901540653818K993268MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUITBTT2000-04-19
17891683903891K993071PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840CBK1999-11-24
17901683903891K993071PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840CBK1999-11-24
17911827815041K993055DEXIDE BIPOLAR FORCEPS II** DEVICEGEI1999-10-05
17931827815041K993055DEXIDE BIPOLAR FORCEPS II** DEVICEGEI1999-10-05
17911056360292K992288AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVEGCJ1999-07-30
17931056360292K992288AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVEGCJ1999-07-30
17891497536629K992133NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTILCBK2000-08-04
17901602869708K991823N-395 PULSE OXIMETER, MODEL N-395DQA1999-08-25
17911066233541K990952NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURESGAT1999-04-01
17911960998758K990951MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTUREGAM1999-04-01
17901276224940K990897NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZERCAF2000-03-15
18221491825730K984552COOL-TIP RF SYSTEMGEI1999-03-05
3152101491825730K984552COOL-TIP RF SYSTEMGEI1999-03-05
17891753591433K984535PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTIONCBK1998-12-28
17901753591433K984535PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTIONCBK1998-12-28
17891319582337K984379NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEMCBK1998-12-10
17901319582337K984379NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEMCBK1998-12-10
18221434362876K982749MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2GEI1998-09-14
18221084217739K982743DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBHGEI1998-09-14
17911351616097K982575MESH, SURGICAL, POLYMERICFTL1998-11-06
17911414967044K981941MULTAPORT CANNULA REDUCER AND ACCESSORIESGCJ1998-07-29
17931414967044K981941MULTAPORT CANNULA REDUCER AND ACCESSORIESGCJ1998-07-29
17911880788543K981935POLYSORB SUTUREGAM1998-06-25
17911640260650K981916LIGASURE VESSEL SEALING SYSTEMGEI1998-08-28
18221640260650K981916LIGASURE VESSEL SEALING SYSTEMGEI1998-08-28
3152101640260650K981916LIGASURE VESSEL SEALING SYSTEMGEI1998-08-28
17911227977221K981582SURGILON, DERMALON, & OPHTHALONGAR1998-07-13
18061408559053K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSMSD1998-11-25
17911876689986K981128SOFSILK SUTUREGAP1998-05-11
17901467468024K981114MICROCAPCCK1998-06-25
18221502295805K980915VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEMFYD1998-06-29
3152101502295805K980915VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEMFYD1998-06-29
2213071453473702K980604SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIESGCJ1998-05-19
18011048539383K980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSMMK1998-02-24
17901043247324K980327MICROSTREAM FILTERLINE ICUCCK1998-04-16
17901225192739K980325MICROSTREAM NASAL CANNULA FILTERLINECCK1998-04-16
17901040328427K980324MICROSTREAM FILLERLINE OR/EMSCCK1998-04-16
18011149482959K9739112 GALLON ALTERNATE CARE SHARPS CONTAINERFMI1997-10-29
17912073409092K973496THE AUTO SUTURE* MIBB** SYSTEMKNW1997-12-01
17882057839441K973419DMR PLUS DISPOSABLE MANUAL RESUSCITATORBTM1998-03-25
17892057839441K973419DMR PLUS DISPOSABLE MANUAL RESUSCITATORBTM1998-03-25
17902057839441K973419DMR PLUS DISPOSABLE MANUAL RESUSCITATORBTM1998-03-25
17911447050818K973297COSMAN COAGULATOR (CC-1) SYSTEMGEI1997-10-29
18221447050818K973297COSMAN COAGULATOR (CC-1) SYSTEMGEI1997-10-29
3152101447050818K973297COSMAN COAGULATOR (CC-1) SYSTEMGEI1997-10-29
17911371127231K973281THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*MAI1997-11-03
17901946715645K973147NPB-295 PULSE OXIMETERDQA1997-11-14
17931198844483K973046SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAKGCJ1998-01-16
18061585193228K972992CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORSCCL1998-03-30
17902000961004K972837NPB-290 PULSE OXIMETER (NPB-290)DQA1997-10-21
17891482622123K972833E100M VENTILATOR (E100M)CBK1999-09-23
17901468543716K972468NPB-195 PULSE OXIMETERDQA1997-09-25
17911772378342K972415MINISITE*BIPOLAR FORCEPS** DEVICEGEI1997-09-19
17931772378342K972415MINISITE*BIPOLAR FORCEPS** DEVICEGEI1997-09-19
17881939331742K972258HI-CARE CLOSED SUCTION SYSTEMBSY1997-12-29
17901939331742K972258HI-CARE CLOSED SUCTION SYSTEMBSY1997-12-29
17901697925354K971946NPB-190 PULSE OXIMETER (NPB-190)DQA1997-08-25
17911984918017K971861ULTRASONIC HAND INSTRUMENTSLFL1997-07-01
17901247057713K971628SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)DQA1997-10-10
17911796839688K970754INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEPGCJ1997-04-21
17931796839688K970754INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEPGCJ1997-04-21
17891927772178K970460NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)CBK1998-04-30
17901927772178K970460NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)CBK1998-04-30
18221289986118K970140E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCHGEI1997-03-28
3152101289986118K970140E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCHGEI1997-03-28
17882015791790K965132HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBESBTR1997-03-20
17902015791790K965132HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBESBTR1997-03-20
18221145868178K964636FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEMGEI1997-03-11
1154961145868178K964636FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEMGEI1997-03-11
3152101145868178K964636FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEMGEI1997-03-11
17892021649290K964540NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEMCBK1997-11-14
17902021649290K964540NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEMCBK1997-11-14
1154961665487357K964425A-V IMPULSE SYSTEM MODEL 6060JOW1997-07-28
18012064461347K964387POINT OF USE II SHARPS-A-GATORMMK1997-03-27
17901168242347K964239COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZERCCK1997-05-09
17911466625005K964175VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODESGEI1996-12-05
18221466625005K964175VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODESGEI1996-12-05
3152101466625005K964175VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODESGEI1996-12-05
17901781864299K963707NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)DQA1996-12-13
17911051650559K963253SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1996-10-08
17911152094511K963115TROCAR CANNULAGCJ1997-02-12
17931152094511K963115TROCAR CANNULAGCJ1997-02-12
17881614059379K962173SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIESJOH1996-10-04
17901614059379K962173SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIESJOH1996-10-04
17881832043296K962045ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KITCAH1996-11-26
17901832043296K962045ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KITCAH1996-11-26
18221075421051K962044VALLEYLAB COATED ELECTRODESGEI1996-08-30
3152101075421051K962044VALLEYLAB COATED ELECTRODESGEI1996-08-30
17911007435365K961940INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEPGCJ1996-07-10
17931007435365K961940INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEPGCJ1996-07-10
17911811864066K961856AUTO SUTURE CHEMOSITE TUNNELERLJS1996-07-18
18061811864066K961856AUTO SUTURE CHEMOSITE TUNNELERLJS1996-07-18
17881514125461K961821ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSORGXY1996-10-04
17901514125461K961821ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSORGXY1996-10-04
17911397958416K961771AUTO SUTURE SURGIWANDGEI1996-09-25
17931397958416K961771AUTO SUTURE SURGIWANDGEI1996-09-25
17911144060171K961578SUTURE ANCHORJDR1996-07-10
17911932072450K961430INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEPGCJ1996-05-28
17931932072450K961430INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEPGCJ1996-05-28
17911883197657K961321GAMMA GUIDANCE SYSTEMIZD1997-02-10
17911772276036K960748MODIFIED HAND INSTRUMENT DEVICESGCJ1996-04-05
17911899427922K955836VALLEYLAB COATED ELECTRODESGEI1996-02-01
18221899427922K955836VALLEYLAB COATED ELECTRODESGEI1996-02-01
3152101899427922K955836VALLEYLAB COATED ELECTRODESGEI1996-02-01
17911270344865K955747USSC NONABSORBABLE SUTURESGAT1996-02-27
17911846062299K955723STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)GAQ1996-02-27
17911691667078K955722FLEXON TEMPORARY CARDIAC PACER LEADLDF1996-03-15
17881612148087K955680SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFEDJOH1996-03-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI2262024-07-12
GCJ932022-06-27
GDW812026-04-10
DQA522022-05-06
CBK512020-11-20
JOH272025-12-29
FLL272024-08-20
BTR262025-10-06
CCK252021-09-17
HIH182018-08-29
LFL152021-11-15
NEY142020-08-26
MWI142016-11-14
FZP142015-09-14
GXY142015-04-16
CAH141996-11-26
KCT122018-07-17
BTT122008-03-31
BTM122003-02-07
FJS112022-01-14
GAM112011-06-03
GAG102024-11-01
MUD102021-12-05
BTO101995-02-27
DWJ82013-07-29
MSD82013-01-31
BYD81995-06-08
JAK72019-08-07
MMK71998-02-24
OCW62023-09-08
LIT62019-04-23
GAT62010-11-10
HET61992-09-28
LLZ52018-03-21
FYD52015-01-14
HWC52004-10-20
MPB42020-01-17
FCG42018-04-26
OLW42007-11-20
GAW42005-06-01

PMA#

PMN#

200 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next