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
9505–9528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2023
EXTRON 5
K230871 · OWB
DRTECH Corporation
Radiology · 140d
Cleared Aug 17, 2023
Tandry Locking Plate System
K230690 · HRS
Microware Precision Co., Ltd.
Orthopedic · 157d
Cleared Aug 17, 2023
Aer-O-Scope Colonoscope System
K230588 · FDF
Gi View , Ltd.
Gastroenterology & Urology · 168d
Cleared Aug 17, 2023
Cadwell Guardian
K230415 · GWF
Cadwell Industries, Inc.
Neurology · 182d
Cleared Aug 17, 2023
InterCollagen® Guide
K223912 · NPL
Sigmagraft, Inc.
Dental · 231d
Cleared Aug 17, 2023
Integrity Implant
K223538 · OWX
Anika Therapeutics, Inc.
Orthopedic · 267d
Cleared Aug 17, 2023
Spirair Nasal Septal Strap
K223167 · NHB
Spirair, Inc.
Ear, Nose, Throat · 314d
Cleared Aug 17, 2023
Feeding Tube
K222773 · PIF
Anhui Tiankang Medical Technology...
Gastroenterology & Urology · 337d
Cleared Aug 17, 2023
Oral/Enteral Syringe with ENFit connector
K222772 · PNR
Anhui Tiankang Medical Technology...
Gastroenterology & Urology · 337d
Cleared Aug 16, 2023
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw)
K232141 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Aug 16, 2023
EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral...
K232126 · GAG
Covidien
General & Plastic Surgery · 30d
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