ClearanceBrief
Company · US

Stryker Instruments

FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2026. Name variants (Inc, Corp, punctuation) are merged.

77510(k) clearances (6 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
GEIElectrosurgical, Cutting & Coagulation & Accessories8
HAWNeurological Stereotaxic Instrument6
FYAGown, Surgical5
JEYPlate, Bone5
FRNPump, Infusion4
GXIProbe, Radiofrequency Lesion3
GXPMethyl Methacrylate For Cranioplasty3
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)3
CACApparatus, Autotransfusion2
DZIDrill, Bone, Powered2
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece2
FQHLavage, Jet2
FTDLamp, Surgical2
GXNPlate, Cranioplasty, Preformed, Non-Alterable2
LFLInstrument, Ultrasonic Surgical2
NDNCement, Bone, Vertebroplasty2
NKBThoracolumbosacral Pedicle Screw System2
OLOOrthopedic Stereotaxic Instrument2
PBZImage Processing Device For Estimation Of External Blood Loss2
DZEImplant, Endosseous, Root-Form1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 20, 2026K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-00
Stryker Instruments
GEI
Oct 8, 2026K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade
Stryker Instruments
LFL
Sep 17, 2026K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® Sa
Stryker Instruments
GEI
Jun 17, 2026K261544Hydro Irrigation System
Stryker Instruments
EOB
May 8, 2026K253679Hydro Irrigation System
Stryker Instruments
GWG
Mar 16, 2026K252282SurgiCount+ System
Stryker Instruments
PBZ
Sep 25, 2025K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attac
Stryker Instruments
OLO
Sep 9, 2025K250483PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
Stryker Instruments
GEI
May 15, 2025K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation Syst
Stryker Instruments
GXI
Apr 15, 2025K250327OptaBlate Radiofrequency (RF) Generator System
Stryker Instruments
GEI
Mar 24, 2025K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
Stryker Instruments
LFL
Mar 21, 2025K243958Consolidated Operating Room Equipment (CORE) 2 Console
Stryker Instruments
OLO
Mar 11, 2025K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur
Stryker Instruments
HBE
Jan 16, 2025K242834System 9 Sterile Battery Container
Stryker Instruments
KCT
Oct 21, 2024K242266PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
Stryker Instruments
GEI
Oct 16, 2024K241272Stryker Steri-Shield 8 Surgical Hoods and Togas
Stryker Instruments
FYA
Apr 29, 2024K240526POWEReam Xia/Serrato
Stryker Instruments
NKB
Jan 11, 2024K232250SurgiCount+ System
Stryker Instruments
PBZ
Dec 26, 2023K233300POWEReam 1/4 Drive
Stryker Instruments
NKB
Dec 20, 2022K223294SpineJack® Expansion Kit
Stryker Instruments
NDN
Dec 9, 2022K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000)
Stryker Instruments
JCX
Jun 25, 2021K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
Stryker Instruments
NDN
Aug 22, 2017K172367Stryker Integrated Bipolar Cord and Tubing Sets
Stryker Instruments
GEI
Mar 23, 2007K063005STRYKER T6 HOODS AND TOGAS
Stryker Instruments
FYA
Dec 14, 2006K062640STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
Stryker Instruments
HAW
Oct 26, 2006K061725STRYKER ARIA PNEUMATIC SYSTEM
Stryker Instruments
HBB
Oct 10, 2006K061660STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
Stryker Instruments
GEI
Sep 8, 2006K061835STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE
Stryker Instruments
GEI
May 31, 2005K043442STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
Stryker Instruments
GXI
May 18, 2005K050753STRYKER DISCMONITOR
Stryker Instruments
FMF
May 10, 2005K043466PAINPUMP2
Stryker Instruments
FRN
Apr 21, 2005K050615STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000
Stryker Instruments
HAW
Mar 17, 2005K050535STRYKER MMF SCREW
Stryker Instruments
DZL
Feb 9, 2005K043334BONE SOURCE HAC RAPID SETTING CEMENT
Stryker Instruments
GXP
Apr 1, 2004K040369STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Stryker Instruments
DZJ
Apr 1, 2004K032406STRYKER RF ELECTRODES AND CANNULAE
Stryker Instruments
GXI
Mar 3, 2004K040300STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
Stryker Instruments
ERL
Jan 16, 2004K032303STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Stryker Instruments
HBE
Nov 7, 2003K032473DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
Stryker Instruments
HRX
Oct 30, 2003K032366BONESOURCE HAC FAST SETTING CEMENT
Stryker Instruments
GXP
Sep 10, 2003K031659UNIVERSAL NEURO SYSTEM
Stryker Instruments
JEY
Aug 8, 2003K032117STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
Stryker Instruments
DZI
Jul 21, 2003K031249MODIFICATION TO STRYKER PAINPUMP
Stryker Instruments
FRN
May 30, 2003K030661STRYKER PAINPUMP2
Stryker Instruments
MEA
Apr 18, 2003K030885MODIFICATION TO STRYKER PAINPUMP2
Stryker Instruments
FRN
Mar 20, 2003K030378STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
Stryker Instruments
GXN
Jan 22, 2003K022365STRYKER NAVIGATION SYSTEM - HIP MODULE
Stryker Instruments
HAW
Dec 17, 2002K022185UNIVERSAL CMF SYSTEM
Stryker Instruments
JEY
Aug 2, 2002K021440BONESOURCE HAC
Stryker Instruments
GXP
Aug 1, 2002K022162STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA
Stryker Instruments
FYA

Newest 50 of 77.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 24, 2022Stryker Instruments
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Open, Classified		 HBEK143320
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