Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

926 results for "Stryker"
145–168 of 926
Search insights Median review: 90d Cleared: 100% Top manufacturer: Stryker Corp. Lead specialty: Orthopedic
Cleared Oct 19, 2022
Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System,...
K221728 · KWQ
Stryker Corporation
Orthopedic · 127d
Cleared Oct 11, 2022
Connected OR Hub with Device and Voice Control, SDC4K Information Management...
K222079 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 88d
Cleared Sep 16, 2022
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion...
K221074 · GEI
Stryker Corporation
General & Plastic Surgery · 157d
Cleared Aug 19, 2022
1688 4K Camera System with Advanced Imaging Modality
K222130 · GCJ
Stryker
General & Plastic Surgery · 32d
Cleared Aug 11, 2022
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
K220731 · MEH
Stryker
Orthopedic · 150d
Cleared Jul 12, 2022
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software,...
K221098 · PGW
Stryker Corporation
Ear, Nose, Throat · 89d
Cleared Jul 08, 2022
Stryker VariAx 2 MIS Calcaneus
K221346 · HRS
Stryker GmbH
Orthopedic · 60d
Cleared Jun 29, 2022
780 nm L11 LED Light Source with AIM
K221611 · OWN
Stryker
General & Plastic Surgery · 26d
Cleared Jun 17, 2022
SPY Laparoscope
K221217 · GCJ
Stryker
General & Plastic Surgery · 51d
Cleared Jun 10, 2022
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
K220319 · HWC
Stryker GmbH
Orthopedic · 127d
Cleared Jun 10, 2022
EasyClip® and EasyClip® Xpress
K210582 · JDR
Stryker GmbH
Orthopedic · 469d
Cleared May 27, 2022
Spine Guidance Software, Stryker Q Guidance System
K220593 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 87d
Cleared May 25, 2022
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
K220481 · GEI
Stryker Sustainability Solutions
General & Plastic Surgery · 96d
Cleared May 25, 2022
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and...
K214046 · GCJ
Stryker
General & Plastic Surgery · 149d
Cleared May 20, 2022
Artisan Bone Plug, Universal Cement Restrictor
K220838 · LZN
Howmedica Osteonics, Dba Stryker...
Orthopedic · 59d
Cleared May 13, 2022
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
K220411 · NUJ
Stryker Sustainability Solutions
General & Plastic Surgery · 88d
Cleared Apr 22, 2022
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688...
K220895 · GCJ
Stryker
General & Plastic Surgery · 25d
Cleared Mar 09, 2022
Acetabular Dome Hole Plug
K220376 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 27d
Cleared Mar 08, 2022
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed...
K211140 · DQA
Stryker Sustainability Solutions
Anesthesiology · 326d
Cleared Mar 08, 2022
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor...
K211138 · NLF
Stryker Sustainability Solutions
Anesthesiology · 326d
Cleared Mar 01, 2022
Restoration® Modular Hip System
K212187 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 231d
Cleared Feb 11, 2022
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
K213328 · HSB
Stryker GmbH
Orthopedic · 129d
Cleared Feb 09, 2022
SDC4K Information Management System with Device and Voice Control Package
K220108 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 27d
Cleared Feb 04, 2022
Stryker Resorbable Fixation System
K213777 · JEY
Stryker Leibinger Micro Implants
Dental · 63d