FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
9241–9264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2023
CoreLink Navigation Instruments
K232116 · OLO
Corelink, LLC
Orthopedic · 30d
Cleared Aug 16, 2023
TA™ Stapler and Loading Unit with DST Series™ Technology
K231491 · GAG
Covidien
General & Plastic Surgery · 85d
Cleared Aug 16, 2023
Harvest Dental HD Gum Strip
K231389 · EBI
Harvest Dental Products, LLC
Dental · 96d
Cleared Aug 16, 2023
Guided Surgery Kit
K231087 · DZI
Implant Direct Sybron Manufacturing, LLC
General Hospital · 121d
Cleared Aug 16, 2023
Powdered Free Sterile Natural Rubber Latex Surgical Gloves
K230832 · KGO
The Egyptian Company For Medical &...
General Hospital · 142d
Cleared Aug 16, 2023
TOPA12 Portable X-ray Unit
K230581 · IZL
Neuf, Inc.
Radiology · 167d
Cleared Aug 16, 2023
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
K230577 · FYA
Medcare Saglik Urunleri Sanayi VE...
General Hospital · 168d
Cleared Aug 16, 2023
Phototherapy System (OL-PDT950)
K230342 · GEX
Shanghai Omni Laser Skinology Co., Ltd.
General & Plastic Surgery · 189d
Cleared Aug 16, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
K230314 · LZA
New Era Medicare Sdn. Bhd.
General Hospital · 191d
Cleared Aug 16, 2023
Celsi Monitor
K230298 · FLL
Hadleigh Health Technologies
General Hospital · 195d
Cleared Aug 16, 2023
SOMNUM (V.1.1.2.)
K223922 · OLZ
Honeynaps Co., Ltd.
Neurology · 229d
Cleared Aug 16, 2023
Kyphoplasty Balloon Catheter
K223709 · HRX
Jiangsu Changmei Medtech Co., Ltd.
Orthopedic · 247d
Cleared Aug 16, 2023
AQUAbase nX
K223479 · FIP
B.Braun Medical, Inc.
Gastroenterology & Urology · 271d
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