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
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
1953081681795209K991599CADD ADMINISTRATION SETFPA1999-06-15
1953081461041451K9914103402 HANDHELD PULSE OXIMETERDQA1999-06-09
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
1953082011113285K991255CADD-TPN ADMINISTRATION SET, MODEL 21-7071FPA1999-06-09
1953081515587048K991086CAPNOCHECK II, MODEL 8400CCK1999-06-09
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
1953081768740827K984618BCI MINI-TORR PLUS, MODEL 6004DXN1999-03-25
1953081037502154K983858SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLESMIA1999-01-29
50951013806164K983559BLOOD TUBING ACCESSORY WITH CLAVE CONNECTORFJK1998-12-24
1953081744617600K983467THERAPEPBWF1999-04-02
1953081610461533K982839CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300MEA1998-11-02
1953082034453463K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400FRN1998-11-04
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
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
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
1953081158646350K973532STEALTH, 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
1953081877432159K970785SIMS HYPERINFLATION BAG SYSTEMNHK1997-06-13
1953081904826023K970596DHD EMERALD PRODUCTBWF1997-05-16
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
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
1953081692553713K961580PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMSLJT1996-09-20
50941408985809K961552CVP POLYURETHANE CATHETERFOZ1997-02-10
2049921408985809K961552CVP POLYURETHANE CATHETERFOZ1997-02-10
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
1953081213069984K960826CADD-PRIZM MODEL 6100 PUMPFRN1996-08-23
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
50942015151449K953573ICU STOPCOK WITH EXTENSION TUBINGFMG1995-10-07
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
97121993280565K952516PRO-VENT, LINE DRAW, PULSATORJKA1995-07-14
1953081993280565K952516PRO-VENT, LINE DRAW, PULSATORJKA1995-07-14
1953081377688870K952214SIMS INTERTECH HYPERINFLATION BAG SYSTEMNHK1995-06-08
1953081068527526K952169SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRICBTM1995-06-08
97031637069047K952160INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)FPA1995-09-21
97081637069047K952160INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)FPA1995-09-21
1953081637069047K952160INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)FPA1995-09-21
1953081438000386K952062PFT FILTERCAH1995-06-08
97081178007089K951805PIPER, MODEL NUMBER UDS-PIPERBFEN1995-07-06
1953081178007089K951805PIPER, MODEL NUMBER UDS-PIPERBFEN1995-07-06
97031191351900K951129NOVATRANS IIDRS1995-04-05
1953081191351900K951129NOVATRANS IIDRS1995-04-05
1953081076469151K951078CATHETER, INTRAVASCULAR OR PERCUTANEOUSLJS1995-07-31
1953081822524743K946289DEVONS POINT LOK NEEDLE PROTECTION DEVICEFMI1995-07-10
1953082023968950K945754NEWOX2DQA1995-07-17
97031310572019K944208IV ADMINISTRATION SET FPAFPA1994-12-13
97081310572019K944208IV ADMINISTRATION SET FPAFPA1994-12-13
1953081310572019K944208IV ADMINISTRATION SET FPAFPA1994-12-13
97111716897238K944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESJOH1994-10-27
1953081716897238K944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESJOH1994-10-27
3485891716897238K944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESJOH1994-10-27
97031073930235K943897NU-SITEFPA1995-02-10
97081073930235K943897NU-SITEFPA1995-02-10
1953081073930235K943897NU-SITEFPA1995-02-10
1953081530604854K9434043301 PULSE OXIMETERDQA1994-10-13
1953081214635135K943310MODEL 6100 AMBULATORY INFUSION SYSTEMMEA1995-02-21
97031915019933K942377TRANSTAR PRESSURE TRANSDUCERDPT1994-08-16
97081915019933K942377TRANSTAR PRESSURE TRANSDUCERDPT1994-08-16
1953081915019933K942377TRANSTAR PRESSURE TRANSDUCERDPT1994-08-16
1953081473552894K942046PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVEFPA1994-10-04
1953081743494669K942024PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEMLJT1994-07-26
1953081833885670K941982CAPNOCHECKCCK1994-10-17
50941474270523K941978HIGH PRESSURE TUBINGDQO1994-12-13
50942028593536K941254DYE MANAGEMENT SYSTEMDQO1994-06-13
2049922028593536K941254DYE MANAGEMENT SYSTEMDQO1994-06-13
2049361811796946K941214LIFESHIELD EXTENSION SETFPK1994-10-03
2049921811796946K941214LIFESHIELD EXTENSION SETFPK1994-10-03
50951810941583K941190CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SETFPA1995-01-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA922025-06-05
FRN712025-04-02
JOH482021-11-26
BTO252018-04-10
DRS202017-11-09
FOZ182016-06-30
DQA182009-05-01
FMI172021-08-26
DYB172019-07-25
LJT152010-03-01
BTR142008-08-13
CAF142004-04-02
MEA132017-08-24
FMG132009-02-25
DQE112014-07-02
BTL112013-09-16
CCK112003-08-19
LHI92025-01-22
BWF92019-10-24
KPE91985-02-15
DWJ82018-07-26
JKA82008-07-21
CBT82007-08-01
DQO82005-12-22
CAH82004-05-13
PHC72026-04-02
QBP72020-03-06
BTM72003-02-11
FLL71992-09-11
DYG71988-05-25
FPB71986-04-09
BSP62018-06-12
MRZ62017-08-25
CAZ62012-09-14
FMF62008-05-02
ONB52018-08-31
LGZ42008-06-02
KRA42007-09-19
PEH32018-05-25
DXQ32016-05-05

NDC#

Aminosyn-PF

ICU Medical Inc.

ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE

Aminosyn-PF

ICU Medical Inc.

ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE

Dextrose

ICU Medical Inc.

dextrose monohydrate

Aminosyn II

ICU Medical Inc.

ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE

Aminosyn II

ICU Medical Inc.

ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE

Ionosol MB and Dextrose

ICU Medical Inc.

DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Normosol-R

ICU Medical Inc.

SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE

Lactated Ringers

ICU Medical Inc.

SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE

Dextrose

ICU Medical, Inc.

dextrose monohydrate

Dextrose

ICU Medical, Inc.

dextrose monohydrate

Dextrose

ICU Medical, Inc.

dextrose monohydrate

Dextrose

ICU Medical, Inc.

dextrose monohydrate

Lactated Ringers

ICU Medical Inc.

SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE

NORMOSOL-M AND DEXTROSE

ICU Medical Inc.

dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate

55 records. Showing 1-40. Next

PMN#

SPIROS

2007-03-20

ICU MEDICAL, INC

65 records. Showing 1-40. Next

Applications#

60 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next