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Data / Medical devices / United States / Stryker Instruments

Stryker Instruments: FDA-registered device maker in Portage, MI, United States, 142 510(k) clearances

Stryker Instruments is registered with the FDA (registration 3015967359) in Portage, MI, United States. It lists 101 device types. The FDA files 142 510(k) clearances under its listings, the newest dated October 8, 2026. 18 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Stryker Instruments
FDA registration number
3015967359
Address
1941 Stryker Way, Portage, MI, United States, 49002
Owner or operator
STRYKER CORP. (1811755)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
December 29, 1977
Registered through
2027
Brand names listed
0250-070-500 Suction Irrigator 2, 0250-070-520 StrykeFlow 2 With Tip, 0485-840-000 - XL Round Diamond Bur, 4 mm, 0485-860-000 - XL Round Diamond Bur, 5.5 mm, 10 PC TRAY, 10.5MM FLEXIBLE REAMER, 10MM FLEXIBLE REAMER, 10cm iQ Broad Knife and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Complaint file establishment, Specification developeraccessdata.fda.gov
Air-Handling Apparatus AccessoryQGI1Complaint file establishment, Specification developeraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Complaint file establishment, Specification developeraccessdata.fda.gov
Apparatus, Exhaust, SurgicalFYD2Complaint file establishment, Specification developeraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Complaint file establishment, Specification developeraccessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-PoweredJCX2Complaint file establishment, Specification developeraccessdata.fda.gov
ArthroscopeHRX2Complaint file establishment, Specification developeraccessdata.fda.gov
Balloon, EpistaxisEMX1Specification developeraccessdata.fda.gov
Battery, Replacement, RechargeableMOQ1Complaint file establishment, Specification developeraccessdata.fda.gov
Bit, SurgicalGFG1Complaint file establishment, Specification developeraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Complaint file establishment, Specification developeraccessdata.fda.gov
Blade, Saw, Surgical, CardiovascularDWH1Complaint file establishment, Specification developeraccessdata.fda.gov
Bone CementLOD2Complaint file establishment, Specification developeraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Complaint file establishment, Specification developeraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Complaint file establishmentaccessdata.fda.gov
Brush, Dermabrasion, PoweredGFE1Complaint file establishment, Specification developeraccessdata.fda.gov
Bur, DentalEJL1Complaint file establishment, Specification developeraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Complaint file establishment, Specification developeraccessdata.fda.gov
Calculator/Data Processing Module, For Clinical UseJQP1Complaint file establishment, Specification developeraccessdata.fda.gov
Camera, Cine, Endoscopic, Without AudioFWL1Complaint file establishmentaccessdata.fda.gov
Catheter, IrrigationGBX1Complaint file establishment, Specification developeraccessdata.fda.gov
Catheter, Multiple LumenGBP1Complaint file establishment, Specification developeraccessdata.fda.gov
Cement ObturatorLZN2Complaint file establishment, Specification developeraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Complaint file establishment, Specification developeraccessdata.fda.gov
Container, Specimen, SterileFMH1Complaint file establishmentaccessdata.fda.gov
Counter, Sponge, SurgicalLWH1Complaint file establishment, Specification developeraccessdata.fda.gov
Diagnostic Neurosurgical Microscope FilterQFX2Complaint file establishmentaccessdata.fda.gov
Dispenser, CementKIH1Complaint file establishment, Specification developeraccessdata.fda.gov
Drill, Bone, PoweredDZI2Complaint file establishment, Specification developeraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Complaint file establishment, Specification developeraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Compound, Powered)HBF2Complaint file establishment, Specification developeraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Complaint file establishment, Specification developeraccessdata.fda.gov
Driver, Wire, And Bone Drill, ManualDZJ2Complaint file establishment, Specification developeraccessdata.fda.gov
Ear, Nose, And Throat Stereotaxic InstrumentPGW2Complaint file establishment, Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Complaint file establishment, Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And RevisionSFQ2Complaint file establishment, Specification developeraccessdata.fda.gov
Endoscope, NeurologicalGWG2Complaint file establishment, Specification developeraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Complaint file establishmentaccessdata.fda.gov
Eustachian Tube Balloon Dilation DevicePNZ2Complaint file establishment, Specification developeraccessdata.fda.gov
Field Generator Positioning DeviceQLV1Specification developeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Complaint file establishment, Specification developeraccessdata.fda.gov
Generator, Lesion, RadiofrequencyGXD2Complaint file establishment, Specification developeraccessdata.fda.gov
Gown, SurgicalFYA2Complaint file establishment, Specification developeraccessdata.fda.gov
Helmet, SurgicalFXZ1Complaint file establishment, Specification developeraccessdata.fda.gov
Hood, SurgicalFXY2Complaint file establishment, Specification developeraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Complaint file establishmentaccessdata.fda.gov
Illuminator, Fiberoptic, Surgical FieldHBI2Complaint file establishmentaccessdata.fda.gov
Image Processing Device For Estimation Of External Blood LossPBZ2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)OAR1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, BiopsyKNW2Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Complaint file establishmentaccessdata.fda.gov
Instrument, Cast Removal, Ac-PoweredLGH1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Complaint file establishmentaccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentKIJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentHSZ1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUComplaint file establishment, Specification developeraccessdata.fda.gov
Lavage, JetFQH2Complaint file establishment, Specification developeraccessdata.fda.gov
Light, Surgical, FiberopticFST2Complaint file establishmentaccessdata.fda.gov
Mask, SurgicalFXX2Complaint file establishment, Specification developeraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Complaint file establishment, Specification developeraccessdata.fda.gov
Motor, Drill, ElectricHBC2Complaint file establishment, Specification developeraccessdata.fda.gov
Motor, Drill, PneumaticHBB2Complaint file establishment, Specification developeraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Complaint file establishment, Specification developeraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Complaint file establishment, Specification developeraccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Specification developeraccessdata.fda.gov
Negative Pressure Wound Therapy Non-Powered Suction ApparatusOKO2Complaint file establishment, Specification developeraccessdata.fda.gov
Non-Surgical GownOEA1Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Complaint file establishment, Specification developeraccessdata.fda.gov
Polymer, Ear, Nose And Throat, Synthetic, AbsorbableNHB2Complaint file establishment, Specification developeraccessdata.fda.gov
Probe, Radiofrequency LesionGXI2Complaint file establishment, Specification developeraccessdata.fda.gov
Regulator, TemperatureJRR1Complaint file establishmentaccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Complaint file establishmentaccessdata.fda.gov
Rongeur, ManualHAE2Complaint file establishment, Specification developeraccessdata.fda.gov
Saw, Powered, And AccessoriesHAB1Complaint file establishment, Specification developeraccessdata.fda.gov
Scale, Sponge, Surgical, Electrically-PoweredMRL1Complaint file establishment, Specification developeraccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Splint, Intranasal SeptalLYA1Complaint file establishment, Specification developeraccessdata.fda.gov
Stand, InfusionFOX1Complaint file establishment, Specification developeraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Complaint file establishment, Specification developeraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Complaint file establishmentaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Complaint file establishmentaccessdata.fda.gov
Syringe, PistonFMF2Complaint file establishment, Specification developeraccessdata.fda.gov
System, Skin ClosureMKY1Complaint file establishment, Specification developeraccessdata.fda.gov
TampHXG1Complaint file establishment, Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Complaint file establishment, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Specification developeraccessdata.fda.gov
Tourniquet, PneumaticKCY1Complaint file establishment, Specification developeraccessdata.fda.gov
Trap, Sterile SpecimenBYZ2Complaint file establishment, Specification developeraccessdata.fda.gov
Tray, Surgical, EntMMO1Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Specification developeraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Complaint file establishmentaccessdata.fda.gov
Unit, Cryosurgical, AccessoriesGEH2Complaint file establishment, Specification developeraccessdata.fda.gov
Unit, Operative DentalEIA1Complaint file establishment, Specification developeraccessdata.fda.gov
Wound Dressing KitMCY2Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 142.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 8, 2026K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328)LFLSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
September 17, 2026K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)GEISubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
June 17, 2026K261544Hydro Irrigation SystemEOBSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
May 8, 2026K253679Hydro Irrigation SystemGWGSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
March 16, 2026K252282SurgiCount+ SystemPBZSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
February 19, 2026K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air MotorOLOSubstantially EquivalentStryker Leibinger GmbH & Co KGaccessdata.fda.gov
February 6, 2026K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting AccessoriesOLOSubstantially EquivalentStryker Leibinger GmbH & Co KGaccessdata.fda.gov
September 25, 2025K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip PointerOLOSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
September 9, 2025K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEISubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
May 15, 2025K251156NPsealOKOSubstantially EquivalentGuard Medical, Inc.accessdata.fda.gov
May 15, 2025K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)GXISubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
April 15, 2025K250327OptaBlate Radiofrequency (RF) Generator SystemGEISubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
April 8, 2025K250708NPsealOKOSubstantially EquivalentGuard Medical, Inc.accessdata.fda.gov
March 24, 2025K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFLSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
March 21, 2025K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleOLOSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
March 11, 2025K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond RHBESubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
January 16, 2025K242834System 9 Sterile Battery ContainerKCTSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
October 16, 2024K241272Stryker Steri-Shield 8 Surgical Hoods and TogasFYASubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
August 27, 2024K241517Q Guidance System; Mako Spine System;OLOSubstantially EquivalentStryker Leibinger GmbH & Co KGaccessdata.fda.gov
August 15, 2024K241522NPseal (20 and 25)OKOSubstantially EquivalentGuard Medical, Inc.accessdata.fda.gov
July 25, 2024K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting AccessoriesOLOSubstantially EquivalentStryker Leibinger GmbH & Co KGaccessdata.fda.gov
June 6, 2024K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary HandpieceOLOSubstantially EquivalentStryker Leibinger GmbH & Co KGaccessdata.fda.gov
May 6, 2024K233800Vertos mild Device Kit (MDK-0002)HRXSubstantially EquivalentVertos Medical, Inc.accessdata.fda.gov
April 29, 2024K240526POWEReam Xia/SerratoNKBSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
March 14, 2024K232567Myriad SPECTRA Light SourceQFXSubstantially EquivalentNico Corporationaccessdata.fda.gov
February 29, 2024K240244NPseal (Small, Medium, Large)OKOSubstantially EquivalentGuard Medical, Inc.accessdata.fda.gov
January 11, 2024K232250SurgiCount+ SystemPBZSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
December 26, 2023K233300POWEReam 1/4 DriveNKBSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
February 16, 2023K223770Sonopet 1Q 3 7cm 1Q LargeLFLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
December 20, 2022K223294SpineJack® Expansion KitNDNSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
December 9, 2022K222552120V 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)JCXSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
September 16, 2022K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceGEISubstantially EquivalentStryker Corporationaccessdata.fda.gov
April 12, 2022K220027Audion ET dilation systemPNZSubstantially EquivalentEntellus Medical, Inc.accessdata.fda.gov
February 10, 2022K212971NPsealOKOSubstantially EquivalentGuard Medical, Inc.accessdata.fda.gov
February 3, 2022K213824Sonopet iQ Ultrasonic Aspirator SystemLFLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
June 30, 2021K210377Stryker iBur hubs and cutting accessoriesHBESubstantially EquivalentStryker Corporationaccessdata.fda.gov
June 25, 2021K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone CementNDNSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
June 9, 2021K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000ERLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
May 14, 2021K211130NPsealOKOSubstantially EquivalentGuard Medical, Inc.accessdata.fda.gov
May 26, 2020K200305NPsealOKOSubstantially EquivalentGuard Medical, Inc.accessdata.fda.gov
March 31, 2020K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemPMLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
March 21, 2020K200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverFXYSubstantially EquivalentStryker Corporationaccessdata.fda.gov
March 6, 2020K191583PhotonBlade with Smoke EvacuationGEISubstantially EquivalentInvuity, Inc.accessdata.fda.gov
February 21, 2020K193118TGS Guidewire and updated Scopis SoftwarePGWSubstantially EquivalentStryker Entaccessdata.fda.gov
February 14, 2020K193502TGS Universal Headrest with Mounting ArmPGWSubstantially EquivalentStryker Entaccessdata.fda.gov
November 10, 2019K192661LATERA Absorbable Nasal Implant SystemNHBSubstantially EquivalentEntellus Medical, Inc. (Aka Stryker Ent)accessdata.fda.gov
September 13, 2019K191599NICO Myriad NOVUSGEISubstantially EquivalentNico Corporationaccessdata.fda.gov
June 18, 2019K191049Stryker MIS and Footed AttachmentsHBESubstantially EquivalentStryker Corporationaccessdata.fda.gov
June 14, 2019K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBESubstantially EquivalentStrykeraccessdata.fda.gov
April 11, 2019K190070Sonopet iQ Ultrasonic Aspirator SystemLFLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
February 26, 2019K190356ClariFixGEHSubstantially EquivalentArrinex, Inc.accessdata.fda.gov
February 7, 2019K182224SafeAir Smoke Evacuator compactFYDSubstantially EquivalentLina Medical Apsaccessdata.fda.gov
December 21, 2018K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRXSubstantially EquivalentStryker Corporationaccessdata.fda.gov
December 14, 2018K182354SafeAir Telescopic Smoke PencilGEISubstantially EquivalentLina Medical Apsaccessdata.fda.gov
September 20, 2018K182340NICO MyriadGEISubstantially EquivalentNico Corporationaccessdata.fda.gov
April 19, 2018K172365Panoramic Oxygen Mask (POM)CCKSubstantially EquivalentPom Medical, LLCaccessdata.fda.gov
February 26, 2018K180327Stryker iVAS 13g Bone Biopsy KitKNWSubstantially EquivalentStryker Corporationaccessdata.fda.gov
January 25, 2018K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRXSubstantially EquivalentStryker Corporationaccessdata.fda.gov
October 5, 2017K172558iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy KitKNWSubstantially EquivalentStryker Corporationaccessdata.fda.gov
September 15, 2017K171840Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
September 7, 2017K172433NICO BrainPathGZTSubstantially EquivalentNico Corporationaccessdata.fda.gov
August 22, 2017K172367Stryker Integrated Bipolar Cord and Tubing SetsGEISubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
May 25, 2017K170242MultiGen™ 2 RF Generator SystemGXDSubstantially EquivalentStryker Corporationaccessdata.fda.gov
April 25, 2017K163507Triton Sponge SystemPBZSubstantially EquivalentGauss Surgical, Inc.,accessdata.fda.gov
April 5, 2017K163509XprESS ENT Dilation SystemPNZSubstantially EquivalentEntellus Medical, Inc.accessdata.fda.gov
April 5, 2017K163435Entellus Medical Reinforced Anesthesia NeedleBSPSubstantially EquivalentEntellus Medical, Inc.accessdata.fda.gov
January 17, 2017K161514Precision Thin Reciprocating Blade, 0.010in.EQJSubstantially EquivalentStryker Corporationaccessdata.fda.gov
November 1, 2016K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonHRXSubstantially EquivalentStryker Corporationaccessdata.fda.gov
September 15, 2016K162053PhotonBladeGEISubstantially EquivalentInvuity, Inc.accessdata.fda.gov
June 23, 2016K161191Latera Absorbable Nasal ImplantNHBSubstantially EquivalentSpirox, Inc.accessdata.fda.gov
April 25, 2016K153407Stryker Neptune 3 Waste Management SystemJCXSubstantially EquivalentStryker Corporationaccessdata.fda.gov
April 13, 2016K160693Neptune E-SEP Smoke Evacuation PencilGEISubstantially EquivalentStryker Corporationaccessdata.fda.gov
January 22, 2016K153679Stryker Neptune E-SEP Smoke Evacuation PencilGEISubstantially EquivalentStryker Corporationaccessdata.fda.gov
November 20, 2015K152641Pi Drive Plus Motor, ExtenderERLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
November 20, 2015K152435PassAssist LED Light FiberLRCSubstantially EquivalentEntellus Medical, Inc.accessdata.fda.gov
November 20, 2015K152434XprESS Multi-Sinus Dilation SystemLRCSubstantially EquivalentEntellus Medical, Inc.accessdata.fda.gov
June 12, 2015K150582Vertaplex® High Viscosity (HV) Radiopaque Bone CementNDNSubstantially EquivalentStryker Corporationaccessdata.fda.gov
May 22, 2015K150801Stryker Maestro Air MotorsHBBSubstantially EquivalentStryker Corporationaccessdata.fda.gov
May 8, 2015K143399Stryker Footed Attachments and Cutting AccessoriesHBESubstantially EquivalentStryker Corp.accessdata.fda.gov
May 1, 2015K143540Stryker MIS Attachments and Cutting AccessoriesHBESubstantially EquivalentStryker Corporationaccessdata.fda.gov
April 23, 2015K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBESubstantially EquivalentStryker Corp.accessdata.fda.gov
March 12, 2015K142801Triton Canister SystemPBZSubstantially EquivalentGauss Surgical, Inc.,accessdata.fda.gov
December 4, 2014K143145SafeAir Smoke PencilGEISubstantially EquivalentLina Medical Apsaccessdata.fda.gov
October 23, 2014K141816HEMOPORELYASubstantially EquivalentPolyganics B.V.,accessdata.fda.gov
October 17, 2014K142252XprESS Multi-Sinus Dilation ToolLRCSubstantially EquivalentEntellus Medical, Inc.accessdata.fda.gov
September 26, 2014K141935STRYKER S2 DRILLERLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
September 4, 2014K141673IVAS 8 GAUGE BONE BIOPSY KITKNWSubstantially EquivalentStryker Corporationaccessdata.fda.gov
August 26, 2014K141095STRYKER STERI-SHIELD FLYTE HYBRID TOGASFYASubstantially EquivalentStryker Corporationaccessdata.fda.gov
August 7, 2014K141423NASOPORE-FDLYASubstantially EquivalentPolyganics B.V.,accessdata.fda.gov
June 26, 2014K140588FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSFXYSubstantially EquivalentStryker Corporationaccessdata.fda.gov
May 9, 2014DEN130015PIXEL 3 SYSTEMPBZUnknownGauss Surgical, Inc.,accessdata.fda.gov
December 20, 2013K133563PATHASSIST LIGHT SEEKERLRCSubstantially EquivalentEntellus Medical, Inc.accessdata.fda.gov
December 20, 2013K132671STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEMJCXSubstantially EquivalentStryker Corporationaccessdata.fda.gov
May 23, 2013K130430IVAS 10MM AND 15MM BALLOON CATHETERHRXSubstantially EquivalentStryker Corporationaccessdata.fda.gov
April 3, 2013K123942STRYKER IVAS BALLOON CATHETERNDNSubstantially EquivalentStryker Corporationaccessdata.fda.gov
July 10, 2012K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPSGEISubstantially EquivalentSynergetics, Inc.accessdata.fda.gov
May 1, 2012K112593STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMERLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
April 25, 2012K113585NASAL/EPISTAXIS PACKLYASubstantially EquivalentCogent Therapeutics, LLCaccessdata.fda.gov
December 7, 2011K110924DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPSGEISubstantially EquivalentSynergetics, Inc.accessdata.fda.gov
February 4, 2010K093062VERTOS MEDICAL MILD DEVICE KITHRXSubstantially EquivalentX-Sten Corp.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
May 6, 202698894Class IIOngoingNeptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management SystemIt has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.accessdata.fda.gov
October 31, 202597833Class IIOngoingNICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NNTape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.accessdata.fda.gov
July 2, 202597133Class IIOngoingStryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systeaccessdata.fda.gov
February 25, 202596393Class IIOngoingOtopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.accessdata.fda.gov
January 8, 202596098Class IIOngoingstryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal BladesPrecision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.accessdata.fda.gov
December 3, 202495856Class IIOngoing100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.accessdata.fda.gov
October 4, 202495502Class IIOngoingStryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when usThere is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed accessdata.fda.gov
September 5, 202495342Class IIOngoing1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, EMay exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.accessdata.fda.gov
July 24, 202495040Class IICompletedStryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.accessdata.fda.gov
June 3, 202494755Class IIOngoingThe Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securelExpired Products distributed to customersaccessdata.fda.gov
September 11, 202393211Class IIOngoingDisposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.accessdata.fda.gov
August 7, 202392841Class IIOngoingStryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical siteaccessdata.fda.gov
July 10, 202392713Class IIOngoingSurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack typeaccessdata.fda.gov
June 28, 202395998Class IIOngoingstryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgeryThere is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).accessdata.fda.gov
June 28, 202395996Class IIOngoingThe 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/NeuroThere is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).accessdata.fda.gov
March 1, 202391849Class IIOngoingStryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patiNot able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complicationsaccessdata.fda.gov
January 25, 202391578Class IIOngoingFinished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.accessdata.fda.gov
June 24, 202290535Class IIOngoingStryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.accessdata.fda.gov

Compare with other makers

Updated October 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.