FDA.reportPublic FDA data

STRYKER MANUFACTURING KALAMAZOO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30079970363007997036STRYKER MANUFACTURING KALAMAZOO1N2026-01-016201 South Sprinkle Road Portage MI US 49002

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2365861300856619K961970COMMAND 2 MICOELECTRIC SURGICAL SYSTEMHWE1996-07-26
2365861572945991K943589STRYKER TOTAL PERFORMANCE SYSTEMHWE1994-12-15
2365861497228030K94354175K STAIGHT DRILLHBE1995-05-18
2365861035746617K943323STRYKER SURGICAL INSTRUMENTS AND ACCESSORIESHRX1994-11-28
2365861285527830K942956SURGICAL INSTRUMENTS AND ACCESSORIESHWE1994-09-23
2365861262941126K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE2019-06-14
2365861676265254K032406STRYKER RF ELECTRODES AND CANNULAEGXI2004-04-01
2365861035153527
2365861073134551
2365861123871521
2365861128574889
2365861194357539
2365861201857593
2365861211090800
2365861254524702
2365861262941126
2365861267565096
2365861268932732
2365861314670529
2365861317411604
2365861361005219
2365861394685657
2365861411259336
2365861453524752
2365861471920666
2365861485025849
2365861486084126
2365861486888557
2365861564125298
2365861579776200
2365861594166459
2365861677604780
2365861707280989
2365861715998030
2365861779407819
2365861789058091
2365861816915807
2365861836257825
2365861870345704
2365861885844819
2365861889157451
2365861921453216
2365861936087384
2365861939701855
2365861971236275
2365862013258972
2365862043094018
2365862057972708

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HBE32019-06-14
HWE31996-07-26
GXI12004-04-01
HRX11994-11-28