FDA.reportPublic FDA data

ICU Medical, Inc.

Matched from indexed company URL: ICU Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12196111219611ICU Medical, Inc.1N2026-01-01201 W Queen St SOUTHINGTON CT US 06489
15268631526863ICU Medical, Inc.1Y2026-01-016250 Shier Rings Rd DUBLIN OH US 43016
17134681713468ICU MEDICAL, INC1Y2026-01-014455 ATHERTON DR. Salt Lake City UT US 84123
18242311824231ICU Medical, Inc.1N2026-01-015700 W 23rd Ave Gary IN US 46406
20240642024064ICU MEDICAL, INC.1N2026-01-0113520 EVENING CREEK DRIVE NORTH SUITE 200 SAN DIEGO CA US 92128
20258162025816ICU MEDICAL, INC.1Y2026-01-01951 CALLE AMANECER SAN CLEMENTE CA US 92673
96150503002999813ICU Medical Costa Rica Ltd.1N2026-01-011 Km Noreste del Centro Comercial Real Cariari ZONA FRANCA GLOBAL Park La Aurora de Heredia CR --
96165673002963732ICU Medical Healthcare Manufacturing S.A. de C.V.1N2026-01-01CARRETERA MIGUEL ALEMAN, KM21.7 PARQUE INDUSTRIAL MONTERREY APODACA Nuevo Leon MX 66603
30088189803008818980ICU Medical, Inc.1Y2026-01-019124 Polk Lane, Suite 101 Olive Branch MS US 38654
30123073003012307300ICU Medical, Inc.1N2026-01-016000 Nathan Lane North Minneapolis MN US 55442
30125420153012542015ICU Medical Nederland B.V.1N2026-01-01Bijsterhuizen 22 - 08 Wijchen Gelderland NL 6604 LD
30133192123013319212ICU MEDICAL, INC.1Y2026-01-01600 N Field Dr Lake Forest IL US 60045
30275791753027579175ICU Medical, Inc.1N2026-01-012625 Main St Highland IN US 46322

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1953081341828718K994216PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEMLJT2000-01-27
1953082018058014K993619CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCKBSP2000-04-28
97081439802466K993282IPI HUMIDIFIER CHAMBERBTT2000-09-18
1953081439802466K993282IPI HUMIDIFIER CHAMBERBTT2000-09-18
50951848962647K993282IPI HUMIDIFIER CHAMBERBTT2000-09-18
1953081917991059K992471SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18BSO1999-10-22
1953081005824893K9918611ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST REBTM2000-01-18
50951352166644K9918611ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST REBTM2000-01-18
2049921325381676K991599CADD ADMINISTRATION SETFPA1999-06-15
1953081681795209K991599CADD ADMINISTRATION SETFPA1999-06-15
1953081461041451K9914103402 HANDHELD PULSE OXIMETERDQA1999-06-09
2049921235647001K991301CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1FPA1999-06-09
1953081860768619K991301CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1FPA1999-06-09
1944191196458008K991300BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICEBWF1999-07-12
1953081196458008K991300BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICEBWF1999-07-12
50951890015058K991300BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICEBWF1999-07-12
2049921188921214K991255CADD-TPN ADMINISTRATION SET, MODEL 21-7071FPA1999-06-09
1953082011113285K991255CADD-TPN ADMINISTRATION SET, MODEL 21-7071FPA1999-06-09
50951217676744K991086CAPNOCHECK II, MODEL 8400CCK1999-06-09
1953081515587048K991086CAPNOCHECK II, MODEL 8400CCK1999-06-09
50951451179105K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
97081920063715K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
97121920063715K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
1944191920063715K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
1953081920063715K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
1953081142900606K990083CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTERFPA1999-02-12
2049921827452551K990083CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTERFPA1999-02-12
1953081768740827K984618BCI MINI-TORR PLUS, MODEL 6004DXN1999-03-25
50951932128208K984618BCI MINI-TORR PLUS, MODEL 6004DXN1999-03-25
1953081037502154K983858SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLESMIA1999-01-29
50951013806164K983559BLOOD TUBING ACCESSORY WITH CLAVE CONNECTORFJK1998-12-24
50951122246169K983467THERAPEPBWF1999-04-02
1953081744617600K983467THERAPEPBWF1999-04-02
1953081610461533K982839CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300MEA1998-11-02
2049921794802334K982839CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300MEA1998-11-02
2049921954676240K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400FRN1998-11-04
1953082034453463K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400FRN1998-11-04
2049921486834503K982836CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEMFRN1998-11-02
1953082026102971K982836CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEMFRN1998-11-02
1953081006266763K982640MEDEX 3000 SERIES SYRINGE INFUSION PUMPFRN1999-04-06
1953081144607089K982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200MHX1998-09-25
2049361929412157K982159ABBOTT PLUM A+ INFUSION PUMPFRN1999-01-12
2049921929412157K982159ABBOTT PLUM A+ INFUSION PUMPFRN1999-01-12
97081140402662K982123CONTRAST CONTROL DEVICEFPA1998-07-21
1953081140402662K982123CONTRAST CONTROL DEVICEFPA1998-07-21
50951420689563K982123CONTRAST CONTROL DEVICEFPA1998-07-21
1953081495833225K981939AUTOCORR PLUS; 3404 OXIMETER/ECG MONITORDQA1998-08-20
97031778137830K981167STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KITCAF1998-06-18
1953081778137830K981167STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KITCAF1998-06-18
1953081670817701K980714BCI 3401 HANDHELD PULSE OXIMETERDQA1998-03-25
50951828806894K980714BCI 3401 HANDHELD PULSE OXIMETERDQA1998-03-25
1953082027462765K980662LICHEN, BACTERIAL IN LINE BREATHING FILTERCAH1998-09-14
1953081982467241K974697REUSABLE FINGER SENSOR 3444DQH1998-03-11
50941409365194K974589SMARTVALVEFPA1998-01-09
1953081636879771K974471PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-ALJT1998-01-22
1953081101222824K974013EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBOREFPA1997-12-17
1953081075157535K973917CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEMFRN1998-01-09
2049921884633167K973917CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEMFRN1998-01-09
1953081158646350K973532STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATORCAF1998-03-19
50951345509445K973532STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATORCAF1998-03-19
2049921321191901K971293LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVEFPA1997-06-27
50941734500013K970855CLAVE CONNECTORFPA1997-06-24
2049921734500013K970855CLAVE CONNECTORFPA1997-06-24
50951394387308K970785SIMS HYPERINFLATION BAG SYSTEMNHK1997-06-13
1953081877432159K970785SIMS HYPERINFLATION BAG SYSTEMNHK1997-06-13
50951466210208K970596DHD EMERALD PRODUCTBWF1997-05-16
1953081904826023K970596DHD EMERALD PRODUCTBWF1997-05-16
50951266309880K970209CAPNOCHECK PLUSCCK1997-04-18
1953081637388961K970209CAPNOCHECK PLUSCCK1997-04-18
1953081908896866K970158BABYPACCBK1998-04-28
1953081463683401K965017REGIONAL ANESTHESIA TRAYSCAZ1997-03-14
50941525850981K964435PRIMARY IV SETFMG1997-04-02
50951525850981K964435PRIMARY IV SETFMG1997-04-02
1953081388564608K962695PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETERLJT1996-10-01
50951438806232K962695PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETERLJT1996-10-01
1953081400306125K962534THERA-MIST NEBULIZER MODEL-P3000CAF1997-02-28
1953081319084508K962175PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBEJOH1997-01-17
1953081147756846K9621563304 PULSE OXIMETERDQA1996-08-28
1953081058694866K961973DHD ACE WITH MASK KITCAF1996-08-15
50951020897815K961580PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMSLJT1996-09-20
1953081692553713K961580PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMSLJT1996-09-20
50941408985809K961552CVP POLYURETHANE CATHETERFOZ1997-02-10
2049921408985809K961552CVP POLYURETHANE CATHETERFOZ1997-02-10
50951458493170K961404MX960 REUSABLE PRESSURE TRANSDUCERDRS1996-06-27
97031532066572K961404MX960 REUSABLE PRESSURE TRANSDUCERDRS1996-06-27
97081532066572K961404MX960 REUSABLE PRESSURE TRANSDUCERDRS1996-06-27
1944191532066572K961404MX960 REUSABLE PRESSURE TRANSDUCERDRS1996-06-27
1953081532066572K961404MX960 REUSABLE PRESSURE TRANSDUCERDRS1996-06-27
1953081520808512K9613181ST RESPONSE DISPOSABLE MANOMETERCAP1996-12-17
1953081491837871K960957EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACKFRN1996-06-04
2049922021872704K960957EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACKFRN1996-06-04
1953081213069984K960826CADD-PRIZM MODEL 6100 PUMPFRN1996-08-23
2049921346843457K960826CADD-PRIZM MODEL 6100 PUMPFRN1996-08-23
50951307732865K960515PARAPACBTL1996-10-10
1953081979505141K960515PARAPACBTL1996-10-10
1953081522440007K955407PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUSLJT1996-02-12
97031223307886K954970STOPCOCK & LUER LOCK PLUGFMG1996-04-22
97081223307886K954970STOPCOCK & LUER LOCK PLUGFMG1996-04-22
1953081223307886K954970STOPCOCK & LUER LOCK PLUGFMG1996-04-22
50951256513299K954813ICU EXTENSION KITFPA1995-11-29
97111585171659K954429KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KITKNT1996-03-08
1953081489090357K954015ABG POINT LOK NEEDLE PROTECTION DEVICECBT1995-11-20
50951544055885K954015ABG POINT LOK NEEDLE PROTECTION DEVICECBT1995-11-20
50942015151449K953573ICU STOPCOK WITH EXTENSION TUBINGFMG1995-10-07
50951216945752K953483SIMS BLUE LINE ENDOBRONCHIAL TUBECBI1995-10-24
1953081660136286K953483SIMS BLUE LINE ENDOBRONCHIAL TUBECBI1995-10-24
1953081855858755K953206DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)CAF1995-08-28
1953081534353242K953126OXILINK (SMALL, MEDIUM, LARGE)DQA1995-09-21
2049361057512610K952799ABBOTT XL3M INFUSION PUMPFRN1996-01-18
2049721057512610K952799ABBOTT XL3M INFUSION PUMPFRN1996-01-18
2049921057512610K952799ABBOTT XL3M INFUSION PUMPFRN1996-01-18
50951660361601K952516PRO-VENT, LINE DRAW, PULSATORJKA1995-07-14
97121993280565K952516PRO-VENT, LINE DRAW, PULSATORJKA1995-07-14
1953081993280565K952516PRO-VENT, LINE DRAW, PULSATORJKA1995-07-14
1953081377688870K952214SIMS INTERTECH HYPERINFLATION BAG SYSTEMNHK1995-06-08
50952063828679K952214SIMS INTERTECH HYPERINFLATION BAG SYSTEMNHK1995-06-08
1953081068527526K952169SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRICBTM1995-06-08
50951440278324K952160INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)FPA1995-09-21
97031637069047K952160INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)FPA1995-09-21
97081637069047K952160INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)FPA1995-09-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA1142025-06-05
FRN872025-04-02
JOH602021-11-26
BTO342018-04-10
DQA302009-05-01
DRS232017-11-09
LJT222010-03-01
FMI202021-08-26
FOZ202016-06-30
BTR192008-08-13
MEA182017-08-24
CAF182004-04-02
DYB172019-07-25
BTL152013-09-16
CCK152003-08-19
CAH142004-05-13
FLL141992-09-11
BWF132019-10-24
DWJ132018-07-26
FMG132009-02-25
JKA132008-07-21
DQE112014-07-02
CBT112007-08-01
BTM102003-02-11
LHI92025-01-22
DQO92005-12-22
KPE91985-02-15
PHC82026-04-02
MRZ82017-08-25
CAZ82012-09-14
FPB81986-04-09
QBP72020-03-06
LGZ72008-06-02
DYG71988-05-25
BSP62018-06-12
FMF62008-05-02
ONB52018-08-31
BSO52006-10-18
KRA42007-09-19
BTT42000-09-18

NDC#

55 records. Showing 1-40. Next

PMN#

65 records. Showing 1-40. Next

Applications#

60 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next