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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

188 results for "third party"
97–120 of 188
Search insights Median review: 30d Cleared: 100% Top manufacturer: Ultradent Products, Inc. Lead specialty: Dental
Cleared Mar 01, 2021
VALO Grand Corded and Accessory Lenses
K210550 · EBZ
Ultradent Products, Inc.
Dental · 4d
Cleared Jan 25, 2021
Non-Contact Forehead Thermometer (Models UT306H & UT308H)
K203747 · FLL
Uni-Trend Technology (China) Co., Ltd.
General Hospital · 34d
Cleared Jan 22, 2021
Non-Contact Forehead Thermometer (UT30H)
K203656 · FLL
Uni-Trend Technology (China) Co., Ltd.
General Hospital · 38d
Cleared Nov 18, 2020
HiRise
K203187 · JAK
Curvebeam, LLC
Radiology · 22d
Cleared Nov 12, 2020
NOVA Patient Warming System
K203085 · DWJ
Encompass Group, LLC
Cardiovascular · 30d
Cleared Nov 12, 2020
Insight Infrared Video Goggles
K203082 · GWN
Vestibular First
Ear, Nose, Throat · 30d
Cleared Oct 30, 2020
eKuore Pro Series
K203007 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 29d
Cleared Oct 22, 2020
Broncoflex Agile
K202180 · EOQ
Axess Vision Technology
Ear, Nose, Throat · 79d
Cleared Oct 06, 2020
CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30,...
K202114 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 68d
Cleared Oct 02, 2020
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram...
K201748 · KGO
Hartalega Sdn Bhd
General Hospital · 98d
Cleared Sep 11, 2020
Aline Ablation Intelligence
K202297 · LLZ
Mirada Medical, Ltd.
Radiology · 29d
Cleared Sep 04, 2020
Astopad Patient Warming System
K202197 · DWJ
Stihler Electronic GmbH
Cardiovascular · 30d
Cleared Sep 03, 2020
Diamond Digital Sleep Orthotic (DDSO)
K202499 · LRK
Diamond Orthotic Laboratory
Dental · 3d
Cleared Aug 12, 2020
Surgical Mask
K201871 · FXX
C & S Paper Yunfu Co., Ltd.
General Hospital · 36d
Cleared Jul 17, 2020
myQA iON
K201798 · LHN
Iba Dosimetry GmbH
Radiology · 17d
Cleared Jun 17, 2020
Aerus Medical Guardian,model F170A
K201220 · FRA
Aerus Medical, LLC
General Hospital · 42d
Cleared May 05, 2020
Lascod Impression Materials
K201184 · ELW
Lascod Spa
Dental · 4d
Cleared Mar 27, 2020
CUBEScan BioCon-1100
K200548 · IYO
Mcube Technology Co., Ltd.
Radiology · 24d
Cleared Mar 03, 2020
OVision Imaging System
K200275 · NFJ
Ophthalmic Labs, Inc.
Ophthalmic · 28d
Cleared Nov 01, 2019
BD Acute Central Line
K190855 · FOZ
Bard Access Systems, Inc. (Bard Has...
General Hospital · 213d
Cleared Oct 31, 2019
Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
K192867 · GEI
Bovie Medical Corporation Dba Apyx...
General & Plastic Surgery · 24d
Cleared Oct 10, 2019
Palladium High Flow Therapy System
K191010 · BTT
Vapotherm, Inc.
Anesthesiology · 177d
Cleared Jun 04, 2019
CORTRAK* 2 Equilateral Enteral Access System
K191340 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 15d
Cleared May 28, 2019
Nihon Kohden SVM-7200 Series Vital Signs Monitor
K190468 · MWI
Nihon Kohden Corporation
Cardiovascular · 91d