FDA.reportPublic FDA data

Stryker US Supply Chain Operations

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30124973083012497308Stryker US Supply Chain Operations1N2026-01-011551 Perry Rd Ste 101 Plainfield IN US 46168

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1896511318673495K971254TRANSEND EX PLATINUM GUIDEWIREDQX1997-07-01
1896511819590793K241768Broadway 8 CatheterQJP2024-12-19
1896511204509984K241637Echo Intracranial Base CatheterQJP2024-12-19
1896511903432166K241272Stryker Steri-Shield 8 Surgical Hoods and TogasFYA2024-10-16
1896511816915807K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)JCX2022-12-09
1896512063294848K202752AXS Vecta 46 Intermediate CatheterQJP2021-08-27
1896511151928210K200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverFXY2020-03-21
1896512054244974K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterQJP2020-02-27
1896511837911985K200117Trevo NXT ProVue RetrieverPOL2020-02-07
1896511612446364K192122Trevo Trak 21 MicrocatheterDQO2019-11-22
1896511063925495K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)NRY2019-03-13
1896511047440689K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cmNRY2018-03-18
1896511952184539K150616Trevo XP ProVue Retriever (4x30mm)NRY2015-06-12
1896511924428706K143145SafeAir Smoke PencilGEI2014-12-04
1896511076490000K140588FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSFXY2014-06-26
1896511885844819K132671STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEMJCX2013-12-20
1896511988400636K132641MODIFIED TREVO PROVUE RETRIEVERNRY2014-01-13
1896511379155104K132629REPROCESSED DILATING TIP TROCARSNLM2013-12-31
1896511340159645K122576TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANTMJN2013-01-11
1896511663328532K113778EXCELSIOR XT-27 MICROCATHETERDQY2012-04-20
1896511675103078K113260MODIFIED CONCENTIRC MICROCATHETERDQO2012-03-09
1896511875947578K063005STRYKER T6 HOODS AND TOGASFYA2007-03-23
1896511035153527
1896511073134551
1896511317411604
1896511715998030

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QJP42024-12-19
NRY42019-03-13
FYA22024-10-16
JCX22022-12-09
FXY22020-03-21
DQO22019-11-22
POL12020-02-07
GEI12014-12-04
NLM12013-12-31
MJN12013-01-11
DQY12012-04-20
DQX11997-07-01