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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
Connected OR Hub0240200100GCJ HRX07613327413281116
(unnamed)5051FPO07613327278361116
(unnamed)5407-120-950CHBE07613327096491116
CinchLockCAT02462MBI07613252633228115
(unnamed)5450040002ERL07613252508090115
Gynnie1061FPO07613327278200114
STRYKER7400-031-000ERL07613327482973112
Maestro5400210058ERL04546540469205110
(unnamed)8208000000HWE07613327304541110
(unnamed)8205000000HWE OLO07613327304466110
Power-LOAD6390FPO07613327261523110
ProCuity300900000000FNL07613327512656110
S33005FNL07613327278422110
(unnamed)5407-120-470HBE07613327096569107
Prime Series1105FPO07613327278156105
Power-PRO 2, High Configuration650705550001FPO07613327559118104
Maestro Air5407-200-000HBB07613327096460103
Synchro SELECTSSFT215STRDQX MOF07613327508574103
Formula0375544000GFA07613327061789101
L90000220210000FCW07613327051339101
(unnamed)0277096325GFA04546540051783101
GAMMA1320-0111HSB04546540716774100
(unnamed)5407-120-050HBE07613327096651100
Prime TC1460-000-000INN07613327282665100
Synchro SELECTSSTD215STRDQX MOF07613327508499100
RemB6400099000ERL0761315493835399
Neptune0703047002GEI0761332737947198
(unnamed)8206000000HWE0761332730447397
CrossFlow0450000000HRX0761332705804896
(unnamed)7206000000HWE0761332706483494
Showing 61–90 of 36,412← PrevNext →
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 →