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
9529–9552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2023
HemoScreen Hematology Analyzer
K222148 · GKZ
Pixcell Medical Technologies, Ltd.
Hematology · 392d
Cleared Aug 15, 2023
21HQ513D, 32HL512D, 31HN713D, 32HQ713D
K232127 · PGY
Lg Electronics.Inc
Radiology · 29d
Cleared Aug 15, 2023
RxSight® Insertion Device (63002)
K231838 · MSS
Rxsight, Inc.
Ophthalmic · 54d
Cleared Aug 15, 2023
Xenix Medical Sacroiliac Fixation System
K231829 · OUR
Ht Medical D.B.A. Xenix Medical
Orthopedic · 55d
Cleared Aug 15, 2023
primaLOK™ SP Interspinous Fusion System
K231807 · PEK
Wenzel Spine, Inc.
Orthopedic · 56d
Cleared Aug 15, 2023
MA012 Aluminum wheelchair, MS019 steel wheelchair
K231750 · IOR
Sichuan Ast Medical Equipment Co., Ltd.
Physical Medicine · 61d
Cleared Aug 15, 2023
Route 92 Medical Full Length 054 Access System
K231583 · QJP
Route 92 Medical, Inc.
Neurology · 76d
Cleared Aug 15, 2023
Implant-One System
K231455 · NHA
Implant Logistics, Inc.
Dental · 89d
Cleared Aug 15, 2023
Vscan Air
K231301 · IYN
GE Medical Systems Ultrasound and...
Radiology · 102d
Cleared Aug 15, 2023
Annalise Enterprise CTB Triage-OH
K231094 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 119d
Cleared Aug 15, 2023
BAROguard
K223874 · KDN
Paragonix Technologies
Gastroenterology & Urology · 235d
Cleared Aug 14, 2023
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K232311 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 12d
Cleared Aug 14, 2023
Autotome Pro RX 39 Sphincterotome
K232162 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 24d
Cleared Aug 14, 2023
Electro-Spec Steri-Caps
K231905 · HTY
Electro-Spec, Inc.
Orthopedic · 46d
Cleared Aug 14, 2023
DESS Dental Smart Solutions
K231434 · NHA
Terrats Medical SL
Dental · 89d
Cleared Aug 14, 2023
ENDOGATOR™ Hybrid Irrigation Tubing
K231418 · OCX
Medivators
Gastroenterology & Urology · 90d
Cleared Aug 14, 2023
Organic cotton tampon, Viscose tampon
K231341 · HEB
Zhejiang Tianqing Manufacturing...
Obstetrics & Gynecology · 97d
Cleared Aug 14, 2023
Stryker Resorbable Fixation System
K231208 · HBW
Stryker Leibinger GmbH & Co KG
Neurology · 109d
Cleared Aug 14, 2023
V-Laser
K231054 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 123d
Cleared Aug 14, 2023
Yomi Robotic System
K231018 · PLV
Neocis, Inc.
Dental · 126d
Cleared Aug 14, 2023
Density
K230663 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 157d
Cleared Aug 14, 2023
SPICCA Stand-Alone Cervical Fusion Cages
K230608 · OVE
Southern Medical (Pty) , Ltd.
Orthopedic · 164d
Cleared Aug 14, 2023
SPICCA Cervical Fusion Cages
K230607 · ODP
Southern Medical (Pty) , Ltd.
Orthopedic · 164d
Cleared Aug 14, 2023
SaintView
K223660 · LLZ
Inviz Corporation
Radiology · 251d