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Stryker GmbH

12690 adverse events · 1783 recalls · 273 clearances · 141 inspections · 5 compliance actions · aggregated across 6 source records

Scorecard
Events per device across the 36,412-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0.048 ▼

1,750 in the last 12 months

Higher volume than 91% of companies with 10+ devices

Recalls per device

0.002 ▼

63 in the last 12 months

Higher volume than 98% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices
36,412 device records · ordered by linked event volume.
BrandModelProduct codesPrimary DILinked events
RemB6400034000ERL076131549382921557
SmartLife7126-120-000HWE076133271288191010
(unnamed)5450400000ERL07613252468356772
RemB6400015000ERL07613154938254559
(unnamed)5407-300-000ERL07613327177350520
Power-PRO6506FPO07613327261639441
(unnamed)5450040001ERL07613252468271409
(unnamed)5407100000ERL07613327096378384
StrykeFlow0250070500GCJ07613327061390362
RemB6400031000ERL07613154938308360
SERFAS Energy0279401200GEI07613327057034355
InTouch2141FNL07613327169232324
STRYKER7400-034-000ERL07613327482980320
16881688010000GCJ07613327420081288
STRYKER7400-015-000ERL07613327483048282
StrykeFlow0250070520GCX07613327061369273
Crossfire0475100000GEI HRX07613327058109270
CORE Sumex5400130000ERL04546540534125259
RemB6400037000ERL07613154938339256
Prime Series1115FPO07613327278217242
L110220230300OWN07613327455915236
Prime Series1125INK07613327278286226
S33005FNL07613327278309221
(unnamed)5450040000ERL07613252468264211
SYNCHRO 14M00313010DQX07613252186922203
(unnamed)5100120472ERL04546540369970200
(unnamed)5450040003ERL07613252508106198
Prime Series1115FPO07613327278330196
Zyphr5100060001HBF04546540716224191
Prime Series1125INK07613327278293187
Showing 1–30 of 36,412Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
DateTypeActionFirm
2017-04-06WLWarning LetterEntellus Medical Inc.
2015-04-08WLWarning LetterThermedx LLC
2013-11-26INJInjunctionPhysio-Control, Inc.
2013-03-06WLWarning LetterStryker Corporation
2013-03-06WLWarning LetterStryker Corporation
Facilities
Registered establishments with their latest FDA inspection outcome.
FEINameLocationLast inspectionWatch
3033273526ArtelonATL, GA, US—
3006125657BERCHTOLD GMBH & CO. KGTUTTLINGEN Baden-Wurttemberg, DE—
3003897776BIOMIMETIC THERAPEUTICS,LLCFRANKLIN, TN, USVAI
3006345872Entellus Medical, IncPlymouth, MN, USOAI
3004123209HEARTSINE TECHNOLOGIES, LTDBELFAST Northern Ireland, GBNAI
3002807172HOWMEDICA INTERNATIONAL S. DE R.L.,LIMERICK Munster, IENAI
3003070421HOWMEDICA OSTEONICS CORPMAHWAH, NJ, USVAI
3005920920HYPERBRANCH MEDICAL TECHNOLOGY INCDurham, NC, USNAI
3014027736IMASCAPPLOUZANE Finistere, FR—
3010673515INTERNATIONAL LIFE SCIENCESSandy Springs, GA, USNAI
3040801290Inari Medical, Costa Rica S.A.Grecia Alajuela, CR—
3020347218Inari Medical, Inc.Irvine, CA, US—
3005445717JOLIFE ABLUND Skane, SENAI
3023527320LimFlow Inc.Irvine, CA, USVAI
3005985723MAKO SURGICAL CORP.Weston, FL, USVAI
3010151377MOBIUS IMAGING, LLCShirley, MA, USVAI
3007456622NICO CORPORATIONIndianapolis, IN, USVAI
3012345110Novadaq Technologies ULCBurnaby British Columbia, CAVAI
3016573902Ortho-Space Ltd.Caesarea Haifa, IL—
3015876PHYSIO-CONTROL, INC.Redmond, WA, USNAI
3010411911POM Medical, LLCMoorpark, CA, USNAI
3008668801SERFDECINES CHARPIEU Rhone, FRNAI
3002975342STRYKER Communications, Inc.Flower Mound, TX, USNAI
1811755STRYKER CORP.KALAMAZOO, MI, USNAI
3008837339STRYKER EMEA Supply Chain ServicesVenlo Limburg, NL—
Showing 1–25 of 61Next →