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
18601–18624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2020
iCTmotor (WL-1)
K193341 · EBW
Dentium Co., Ltd.
Dental · 276d
Cleared Sep 04, 2020
MEBO Wound Dressing
K193439 · FRO
Mebo Life Science, Inc.
General & Plastic Surgery · 268d
Cleared Sep 04, 2020
MSLS6QF TENS/PMS Device
K193655 · NUH
Self Doctor Care, LLC
Neurology · 249d
Cleared Sep 04, 2020
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
K200835 · FRO
3M Company
General & Plastic Surgery · 157d
Cleared Sep 04, 2020
Arthrex NanoScope System
K201134 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 129d
Cleared Sep 04, 2020
Neodent Implant System - GM Helix Implants 7.0
K201225 · DZE
Jjgc Industria E Comercio DE...
Dental · 121d
Cleared Sep 04, 2020
Plain Surgical Mask
K201517 · FXX
Aok Tooling Limited
General Hospital · 88d
Cleared Sep 04, 2020
Protective Face Mask for Medical Use
K201537 · FXX
Shandong Shengquan New Material Co.,...
General Hospital · 88d
Cleared Sep 04, 2020
TruLift Expandable Spacer System
K201721 · MAX
Life Spine, Inc.
Orthopedic · 73d
Cleared Sep 04, 2020
Astopad Patient Warming System
K202197 · DWJ
Stihler Electronic GmbH
Cardiovascular · 30d
Cleared Sep 04, 2020
SIGNA Artist
K202238 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 28d
Cleared Sep 04, 2020
Ambra ProViewer
K202335 · LLZ
Dicom Grid Inc Dba Ambra Health
Radiology · 18d
Cleared Sep 03, 2020
Biodegradable Nitrile Examination Powder Free Glove, Green
K192111 · LZA
Top Glove Sdn. Bhd.
General Hospital · 395d
Cleared Sep 03, 2020
Lyograft
K192452 · FTM
B. Bruan Surgical, SA
General & Plastic Surgery · 360d
Cleared Sep 03, 2020
BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450...
K193599 · ITI
21st Century Scientific, Inc.
Physical Medicine · 255d
Cleared Sep 03, 2020
MIS Dental Implant System
K200102 · DZE
Dentsply Sirona
Dental · 230d
Cleared Sep 03, 2020
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K200212 · MTD
Innovative Health, LLC
Cardiovascular · 219d
Cleared Sep 03, 2020
HaloGUARD Protective Disc with CHG
K200641 · FRO
Attwill Medical Solutions
General & Plastic Surgery · 176d
Cleared Sep 03, 2020
Delta III Lithotripter
K201074 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 134d
Cleared Sep 03, 2020
Cliq Aspirator
K201203 · BTA
Anest Iwata Sparmax Co., Ltd.
General & Plastic Surgery · 122d
Cleared Sep 03, 2020
3MP Color LCD Monitors C32S+, C32SP+
K201211 · PGY
Shenzhen Beacon Display Technology...
Radiology · 121d
Cleared Sep 03, 2020
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary...
K201336 · JDS
Synthes USA Products, LLC
Orthopedic · 106d
Cleared Sep 03, 2020
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
K201522 · HTN
Arthrex, Inc.
Orthopedic · 87d
Cleared Sep 03, 2020
Flat Panel Detector
K201591 · MQB
Ka Imaging, Inc.
Radiology · 83d