Stryker Corporation
Stryker Corporation holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2023, with 115 FDA device recalls on record.
Top product codes for Stryker Corporation
FDA recalls by Stryker Corporation
10 most recent of 115- Z-2864-2026 — STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
- Z-2862-2026 — STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
- Z-2865-2026 — STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
- Z-2863-2026 — STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
- Z-2866-2026 — STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
- Z-2282-2026 — Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
- Z-2166-2026 — Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
- Z-1427-2026 — MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
- Z-0601-2026 — NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;
- Z-0599-2026 — NICO 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; NN-8008 19x28 MHP OI; NN-8010 17x31.5 MHP DECQ; NN-8015 NICO Fluid System (NFS); NN-8017 11x13 MHP/PB; NN-8018 13X13 MHP/PB; NN-8019 19x28 MHP Little LOTTA; NN-8020 19x21.5 MHP PaediScope; NN-8021 15x26.5 MHP LOTTA; NN-8500 15x10 MHP; NN-8501 15x13 MHP; NN-8502 15x25 MINOP MHP; NN-8503 13x10 MHP; NN-8504 13x13 MHP; NN-8505 15x25 GAAB MHP; NN-8506 11X10 MHP; NN-8507 11x13 MHP; NN-8508 19x28 OI MHP; NN-8510 17x31.5 DECQ MHP; NN-8517 13X13 MHP/PB; NN-8518 11x13 MHP/PB; NN-8519 19x28 Little LOTTA MHP; NN-8520 19x21.5 PaediScope MHP; NN-8521 15X26.5 LOTTA MHP;
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Stryker Corporation
- K232157 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- K212194 — Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
- K223770 — Sonopet 1Q 3 7cm 1Q Large
- K221728 — Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate
- K221074 — OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
- K221098 — Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
- K213824 — Sonopet iQ Ultrasonic Aspirator System
- K212055 — Connected OR Hub with Device and Voice Control
- K210377 — Stryker iBur hubs and cutting accessories
- K202964 — iBed Wireless with iBed Mobile
- K211490 — Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
- K202393 — SpineJack Expansion Kit
- K202609 — Instrument Clamps Electromagnetic
- K201585 — Monterey AL Interbody System
- K200613 — Tritanium® X TL Expandable Curved Posterior Lumbar Cage
- K192818 — Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
- K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
- K191049 — Stryker MIS and Footed Attachments
- K190070 — Sonopet iQ Ultrasonic Aspirator System
- K183196 — Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
- K181752 — Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
- K180327 — Stryker iVAS 13g Bone Biopsy Kit
- K172116 — Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
- K172034 — Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
- K172724 — XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
- K172558 — iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
- K171840 — Stryker Consolidated Operating Room Equipment (CORE) 2 Console
- K171807 — ES2 Neuromonitoring Accessory Instruments
- K170242 — MultiGen 2 RF Generator System
- K170496 — Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
- K162937 — Stryker OrthoMap Versatile Hip System
- K162929 — Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
- K161514 — Precision Thin Reciprocating Blade, 0.010in.
- K162062 — AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
- K160715 — AccuLIF TL and PL Cage
- K160978 — LITe BIO Delivery System
- K160050 — SERFAS 90-S Electrosurgical Probe
- K153407 — Stryker Neptune 3 Waste Management System
- K160693 — Neptune E-SEP Smoke Evacuation Pencil
- K151932 — Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing
- K153679 — Stryker Neptune E-SEP Smoke Evacuation Pencil
- K151726 — AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer
- K152651 — AccuLIF TL and PL Cage
- K152632 — XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
- K152641 — Pi Drive Plus Motor, Extender
- K150700 — ACP 1 Anterior Cervical Plating System
- K151755 — OASYS(r) System
- K150582 — Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
- K150753 — OASYS System
- K150801 — Stryker Maestro Air Motors
- K150539 — OASYS System
- K143540 — Stryker MIS Attachments and Cutting Accessories
- K143546 — Imbibe Aspirating XIA Taps
- K143616 — AccuLIF TL and PL Cage
- K142237 — Aviator Anterior Cervical Plate (ACP) System
- K143163 — AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System
- K142741 — OASYS System
- K142699 — LITe Plate System
- K142251 — AVS AS PEEK Spacer
- K142066 — AERO-LL LUMBAR CAGE SYSTEM
- K142114 — Xia® Growth Rod Conversion Set
- K141935 — STRYKER S2 DRILL
- K141673 — IVAS 8 GAUGE BONE BIOPSY KIT
- K141095 — STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
- K141217 — ACCULIF TL AND PL CAGE
- K140400 — ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
- K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
- K133328 — AERO-AL LUMBAR CAGE SYSTEM
- K140095 — PRIME ZOOM STRETCHER
- K121664 — T4/T5 HYTREL TOGAS
- K132671 — STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
- K130430 — IVAS 10MM AND 15MM BALLOON CATHETER
- K123942 — STRYKER IVAS BALLOON CATHETER
- K112593 — STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
- K113154 — IVAS BALLOON CATHETER
- K111478 — STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
- K103807 — IVAS 2-10MM (10 GUAGE) BALLON CATHETER
- K103400 — FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
- K103292 — TRIO TRAUMA SPINAL SYSTEM
- K103536 — IBED WIRELESS WITH IBED AWARENESS
- K103124 — SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.