FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
11113–11136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 2023
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT...
K213755 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 444d
Cleared Feb 17, 2023
Infrared Thermometer TET-351
K220276 · FLL
Truly Instrument Limited
General Hospital · 382d
Cleared Feb 17, 2023
Doctor Tecar Plus, Doctor Tecar Smart
K221043 · PBX
Mectronic Medicale S.R.L.
General & Plastic Surgery · 315d
Cleared Feb 17, 2023
FlowSaver Blood Return System
K221483 · CAC
Inari Medical, Inc.
Cardiovascular · 270d
Cleared Feb 17, 2023
Equashield Closed System Transfer Device
K221513 · ONB
Equashield Medical , Ltd.
General Hospital · 268d
Cleared Feb 17, 2023
PROstep(TM) MIS 5mm Chamfer Screw System
K221645 · HWC
Wright Medical Technology
Orthopedic · 256d
Cleared Feb 17, 2023
EON
K222226 · PKT
Dominion Aesthetic Technologies, Inc.
General & Plastic Surgery · 207d
Cleared Feb 17, 2023
Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
K222588 · FLL
Iweecare Co., Ltd.
General Hospital · 175d
Cleared Feb 17, 2023
troCarWash™ System
K222695 · OCX
Biotex, Inc.
General & Plastic Surgery · 164d
Cleared Feb 17, 2023
ULTRABUTTON QUAD Adjustable Fixation Device
K222971 · MBI
Smith & Nephew, Inc.
Orthopedic · 143d
Cleared Feb 17, 2023
DSPS-Prominent™ Masks
K222977 · IYE
Macromedics BV
Radiology · 142d
Cleared Feb 17, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
K223466 · FGB
STERIS Corporation
Gastroenterology & Urology · 92d
Cleared Feb 17, 2023
Spectrum Saliva Collection Device
K223497 · QBD
Spectrum Solutions, LLC
Microbiology · 88d
Cleared Feb 17, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
K223545 · NRY
Alembic, LLC
Neurology · 84d
Cleared Feb 17, 2023
Glidewell TuffSplint™ Appliance Resin
K223798 · MQC
Prismatik Dentalcraft, Inc.
Dental · 60d
Cleared Feb 17, 2023
EzDent-i / E2 / Prora View/ Smart M Viewer
K223820 · LLZ
Ewoosoft Co., Ltd.
Radiology · 58d
Cleared Feb 17, 2023
Excipio LV Thrombectomy Device
K223897 · QEW
Contego Medical, Inc.
Cardiovascular · 51d
Cleared Feb 16, 2023
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker...
K212194 · HAW
Stryker Corporation
Neurology · 582d
Cleared Feb 16, 2023
Surgical Gown
K213844 · FYA
Bayteks Teknik Tekstil San. VE Tic. A.S.
General Hospital · 434d
Cleared Feb 16, 2023
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
K220698 · IOR
Panthera AB
Physical Medicine · 344d
Cleared Feb 16, 2023
Single-use Video Pancreaticobiliary Scope, PB Digital Controller
K221784 · FBN
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 240d
Cleared Feb 16, 2023
Passeo-35 Xeo Peripheral Dilatation Catheter
K222065 · LIT
Biotronik, Inc.
Cardiovascular · 218d
Cleared Feb 16, 2023
Disposable Infusion Bag for Parenteral Nutrition
K222622 · KPE
Beijing L&Z Medical Technology...
General Hospital · 169d
Cleared Feb 16, 2023
uMR 680
K222755 · LNH
Shanghai United Imaging Intelligence...
Radiology · 157d