FDA.reportPublic FDA data

SMITHS MEDICAL ASD, INC.

Matched from indexed company URL: Smiths Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12170521217052SMITHS MEDICAL ASD, INC.1Y2020-04-2510 BOWMAN DR. KEENE NH US 03431
21831612183161SMITHS MEDICAL ASD, INC.1Y2020-04-253350 Granada Avenue North Oakdale MN US 55128
30101897643010189764Smiths Medical International Ltd.1N2020-04-2552 Grayshill Road, Westfield Cumbernauld Glasgow Scotland GB G68 9HQ

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
97212018058014K993619CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCKBSP2000-04-28
97211917991059K992471SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18BSO1999-10-22
97191515587048K991086CAPNOCHECK II, MODEL 8400CCK1999-06-09
97191768740827K984618BCI MINI-TORR PLUS, MODEL 6004DXN1999-03-25
97211037502154K983858SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLESMIA1999-01-29
97191610461533K982839CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300MEA1998-11-02
97192034453463K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400FRN1998-11-04
97192026102971K982836CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEMFRN1998-11-02
97191006266763K982640MEDEX 3000 SERIES SYRINGE INFUSION PUMPFRN1999-04-06
97191144607089K982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200MHX1998-09-25
97191670817701K980714BCI 3401 HANDHELD PULSE OXIMETERDQA1998-03-25
97191075157535K973917CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEMFRN1998-01-09
97191637388961K970209CAPNOCHECK PLUSCCK1997-04-18
97191908896866K970158BABYPACCBK1998-04-28
97211463683401K965017REGIONAL ANESTHESIA TRAYSCAZ1997-03-14
97191147756846K9621563304 PULSE OXIMETERDQA1996-08-28
97191491837871K960957EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACKFRN1996-06-04
97191213069984K960826CADD-PRIZM MODEL 6100 PUMPFRN1996-08-23
97211489090357K954015ABG POINT LOK NEEDLE PROTECTION DEVICECBT1995-11-20
97191534353242K953126OXILINK (SMALL, MEDIUM, LARGE)DQA1995-09-21
97211993280565K952516PRO-VENT, LINE DRAW, PULSATORJKA1995-07-14
97211822524743K946289DEVONS POINT LOK NEEDLE PROTECTION DEVICEFMI1995-07-10
97191530604854K9434043301 PULSE OXIMETERDQA1994-10-13
97191214635135K943310MODEL 6100 AMBULATORY INFUSION SYSTEMMEA1995-02-21
97191833885670K941982CAPNOCHECKCCK1994-10-17
97191015884045K9404463M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)FRN1994-08-15
97192066964123K936223PRESSURE IRRIGATING SYSTEMGCY1994-05-12
97211470862007K934465DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINEBTR1994-01-14
97211087992438K923127NEEDLE-PRO CARTRIDGEFMI1993-04-29
97211210366438K923090SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOODJKA1992-09-01
97211406446793K922445VACU-PROJKA1992-08-12
97191042160088K920082BIOCHEM MODEL 3301 NEWOX1 OXIMETERDQA1993-01-07
97191408338168K9121933000 INFUSION PUMPFRN1992-02-14
97211658464652K912124TRACHEOSTOMY TUBE AND CUFFBTO1991-08-16
97191110131483K911791CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMPMEA1991-06-11
97211188149903K911638SYRINGE TIP CAPJKA1991-06-21
97191514695862K911383HOTLINE FLUID WARMERLGZ1991-10-17
97211893674243K903730D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBESBTO1990-09-25
97191667511834K902374CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEMFRN1990-09-14
97192033521353K901755MODEL 3001 SYRINGE INFUSION PUMPFRN1990-08-29
97191298315018K900888LOCKBOXFRN1990-05-15
97211549189748K895705SHAMROCK SAFETY BLOOD COLLECTION SETFMI1989-10-10
97191993361045K893877BIOCHEM 3100 OXIMETERDQO1989-12-20
97191266375817K890120SYRINGE INFUSION PUMPFRN1989-07-27
97191644149096K873856BIOCHEM 9090 CAPNOGRAPH/SAO2CCK1987-12-17
97191834002776K871133BIOCHEM 8090 CAPNOGRAPHCCK1987-04-21
97192052523220K864902MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.CCK1987-01-28
97192036971308K863883MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULACCK1986-10-27
97211607326188K862167MINI-TRACH KITBTO1986-08-06
1692531607326188K862167MINI-TRACH KITBTO1986-08-06
97191092146522K854333BIOCHEM 515 RESPIRATION MONITORBZQ1986-05-30
97211071857594K851986STOPCOCKSFMG1985-05-23
97191719218904K850747TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTORCCK1985-04-02
97211391330757K840986PREFILLED PULSATOR SYRINGECBT1984-04-05
97211543604613K832778EPIDURAL SYRINGECAZ1983-09-26
97191594197570K822819TRIMED 510 APNEA MONITORBZQ1982-11-04
97211650436664K780419SUBCLAVIAN TRAYKGO1978-03-27
97211541024899K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tubeJOH2018-05-08
97211959523179K172823Portex NRFit Epidural NeedlesBSP2018-06-12
1692531959523179K172823Portex NRFit Epidural NeedlesBSP2018-06-12
1692531657009280K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectorsMIA2018-06-14
97211711676790K172410Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio FiltersBSP2018-06-01
97211851196944K171968EchoGlo NeedleBSP2018-01-25
97191574786097K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)MEA2017-08-24
97191537471846K141686EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODYDWJ2014-10-28
97191199722592K141193MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0PHC2014-07-25
97192022322077K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0MEA2013-12-09
97211198596224K121525PERIFUSE CATHETERCAZ2012-08-02
97191576623643K111386MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)FRN2011-08-29
97191640396283K111275CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWAREFRN2013-02-01
97211975281527K110053CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KITCAZ2012-09-14
97211884631776K092657EPIFUSE CATHETER CONNECTOR, MODEL: 4909ECAZ2009-11-04
97191856574705K091181LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPSMRZ2009-06-12
97211916680434K090261PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18GBSP2009-05-01
97191709545463K090205BCI WW1021 PC APPLICATIONDQA2009-04-28
97191729822779K083787BCI WW1000 PULSE OXIMETER, MODEL WW1000DQA2009-04-15
97191839902268K083705BCI WW1020 PULSE OXIMETER, MODEL WW1020DQA2009-04-09
97191910152429K083557BCI WW1030 PULSE OXIMETERDQA2009-05-01
97211744925456K073188HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICEFMI2008-02-08
97191103905803K072144CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATORMEA2008-03-07
97191770945133K072080NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,LGZ2008-06-02
97211678599101K071785HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGEFMI2007-08-02
97191435691963K070732BCI AUTOCON 3304 DIGITAL PULSE OXIMETERDQA2007-07-09
97211905290376K063755PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGEMEG2007-02-27
97211607375316K062005PORTEX EPIDURAL CATHETERBSO2006-10-18
97211635052259K061194PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558MEG2006-08-24
97211848731133K060945PORTEX PERCUTANEOUS TRACHEOSTOMY KITBTO2006-06-19
97191783035341K051568CADD-MS 3 AMBULATORY INFUSION PUMPFRN2005-11-17
97211798066163K051524LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216BSO2005-07-07
97211291516393K042683WELL LEAD ENDOTRACHEAL TUBEBTR2005-02-18
97191237788270K042432PHARMGUARD TOOLBOX, MODEL G6000782FRN2005-01-04
97211319531840K041399HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICEFMI2004-07-28
97211836204130K041348PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRAJOH2004-07-13
1692531836204130K041348PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRAJOH2004-07-13
97191177076632K040899MEDEX 3000 SERIES MR SYRINGE INFUSION PUMPFRN2004-04-30
97211801186261K033080PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETERCAZ2004-03-10
97191301244059K031742BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETERDQA2003-08-18
97211657964756K031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KITJOH2003-07-18
97191483654388K030407ADVISOR, MODEL 9200CCK2003-08-19
97191299256002K020655DELTEC INSULIN INFUSION PUMP AND ACCESSORIESLZG2002-08-13
97211184905501K014073HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICEFMF2002-02-13
97211445988372K011925HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIOFMI2001-07-12
97191785137167BK940056
97191154237329BK860023
97191391044400BK020043
97211003015463
97211049251079
97211086568540
97211112662330
97211141234884
97211376170921
97211399529910
97191417777472
97191440664319
97191540535147
97191575686228
97211692183801
97211716785015
97211832808160
97191899793282

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRN172013-02-01
DQA112009-05-01
CCK92003-08-19
FMI72008-02-08
BSP62018-06-12
MEA62017-08-24
CAZ62012-09-14
BTO52006-06-19
JOH42018-05-08
JKA41995-07-14
BSO32006-10-18
MIA22018-06-14
LGZ22008-06-02
MEG22007-02-27
BTR22005-02-18
CBT21995-11-20
BZQ21986-05-30
DWJ12014-10-28
PHC12014-07-25
MRZ12009-06-12
LZG12002-08-13
FMF12002-02-13
DXN11999-03-25
MHX11998-09-25
CBK11998-04-28
GCY11994-05-12
DQO11989-12-20
FMG11985-05-23
KGO11978-03-27

PMA#

PMN#

87 records. Showing 1-40. Next

GUDID#