Company
Stryker Instruments Div. of Stryker Corporation
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
448recalls (0 in 12 months)
362recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 94 |
| FRN | Pump, Infusion | 78 |
| MEB | Pump, Infusion, Elastomeric | 46 |
| FYA | Gown, Surgical | 30 |
| CAC | Apparatus, Autotransfusion | 29 |
| GXZ | Electrode, Needle | 19 |
| HAW | Neurological Stereotaxic Instrument | 17 |
| JDZ | Mixer, Cement, For Clinical Use | 13 |
| MEA | Pump, Infusion, Pca | 12 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | 10 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 8 |
| FYD | Apparatus, Exhaust, Surgical | 8 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 8 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 8 |
| KCY | Tourniquet, Pneumatic | 7 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 6 |
| LFL | Instrument, Ultrasonic Surgical | 6 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 5 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 4 |
| GDF | Guide, Needle, Surgical | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2022 | Stryker Instruments Div. of Stryker Corporation SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during su Terminated |
LWH | K060076 |
| Nov 6, 2020 | Stryker Instruments Div. of Stryker Corporation Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients.
Catal Terminated |
HBF | K082010 |
| Mar 26, 2020 | Stryker Instruments Div. of Stryker Corporation Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications Terminated |
GEI | K182354 |
| Jan 28, 2020 | Stryker Instruments Div. of Stryker Corporation Telescopic Uncoated (Push
Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332 Terminated |
GEI | K182354 |
| Jan 28, 2020 | Stryker Instruments Div. of Stryker Corporation Telescopic Smoke Evac Pencil,
PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332 Terminated |
GEI | K182354 |
| Jan 28, 2020 | Stryker Instruments Div. of Stryker Corporation SafeAir Telescopic Smoke
Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332 Terminated |
GEI | K182354 |
| Jan 22, 2020 | Stryker Instruments Div. of Stryker Corporation Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation o Terminated |
PBZ | K142801 |
| Nov 6, 2019 | Stryker Instruments Div. of Stryker Corporation Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Terminated |
KCY | None listed |
| Nov 6, 2019 | Stryker Instruments Div. of Stryker Corporation Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tournique Terminated |
KCY | None listed |
| Jul 31, 2019 | Stryker Instruments Div. of Stryker Corporation C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319
Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identificatio Terminated |
ETN | K152505 |
| Jul 31, 2019 | Stryker Instruments Div. of Stryker Corporation C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329
Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identificatio Terminated |
ETN | K152505 |
| Mar 19, 2019 | Stryker Instruments Div. of Stryker Corporation Performance Series Sagittal Blade, Catalog Number 6125-127-100
Product Usage:
The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in vario Terminated |
GFA | None listed |
| Dec 4, 2018 | Stryker Instruments Div. of Stryker Corporation Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 Terminated |
FQA | None listed |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100
Sterile personal protection garment Terminated |
FYA | K070078 |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Zipper Toga, X-Large; Catalog number: 0400-850-000
Sterile personal protection garment Terminated |
FYA | K070078 |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Zipper Toga, Regular; Catalog number: 0400-830-000
Sterile personal protection garment Terminated |
FYA | K070078 |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100
Sterile personal protection garment Terminated |
FYA | K070078 |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000
Sterile personal protection garment Terminated |
FYA | K070078 |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Zipper Toga (S/M); Catalog Number: 0400-810-000
Sterile personal protection garment Terminated |
FYA | K070078 |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000
Sterile personal protection garment Terminated |
FYA | K070078 |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Pullover Toga, Large; Catalog Number: 0400-760-000
Sterile personal protection garment Terminated |
FYA | K070078 |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000
Sterile personal protection garment Terminated |
FYA | K070078 |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000
Sterile personal protection garment Terminated |
FYA | K070078 |
| Feb 23, 2018 | Stryker Instruments Div. of Stryker Corporation T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000
Sterile personal protection garment Terminated |
FYA | K070078 |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853
for orthopedic use. Terminated |
LXH | None listed |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969
for spinal orthopedic use. Terminated |
HRX | K130430 |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830
for spinal orthopedic use. Terminated |
NDN | K123942 |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114
for orthopedic use. Terminated |
JDZ | None listed |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971
for orthopedic use. Terminated |
JDZ | None listed |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259
Bone cement. Terminated |
LOD | K032945 |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use. Terminated |
OAR | None listed |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415
for orthopedic use. Terminated |
JDZ | None listed |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307
for spinal orthopedic use. Terminated |
OAR | None listed |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01 Terminated |
FQH | None listed |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: ( Terminated |
JDZ | None listed |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880
for orthopedic use. Terminated |
JDZ | None listed |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415
for orthopedic use. Terminated |
JDZ | None listed |
| Oct 16, 2017 | Stryker Instruments Div. of Stryker Corporation The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of
the navigation software and creation of a pathway into the pedicle. The instrument has three
types of butto Terminated |
HAW | K012380 |
| Apr 19, 2017 | Stryker Instruments Div. of Stryker Corporation Stryker PROFESS Registration Kit.
The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer- Terminated |
PGW | K141551 |
| Feb 28, 2017 | Stryker Instruments Div. of Stryker Corporation Stryker SmartLife Large Aseptic Housing (7126-120-000) Terminated |
HWE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting acce Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting acce Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8450-010-040 4.0MM Round, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting accessory con Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting acce Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting acce Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting Terminated |
HBE | None listed |
| Dec 21, 2016 | Stryker Instruments Div. of Stryker Corporation 8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting Terminated |
HBE | None listed |
| Nov 16, 2016 | Stryker Instruments Div. of Stryker Corporation RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U Terminated |
GXD | K071482 |
| Oct 18, 2016 | Stryker Instruments Div. of Stryker Corporation Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090
Product Usage:
Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedu Terminated |
HWE | None listed |
| Aug 23, 2016 | Stryker Instruments Div. of Stryker Corporation 120 V Neptune 3 Rover, Model Number: 0703-001-000 Terminated |
JCX | K153407 |
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