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
9553–9576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2023
TK Pre-Filled Normal Saline Flush Syringe
K230756 · NGT
Anhui Tiankang Medical Technology...
General Hospital · 145d
Cleared Aug 12, 2023
Pulse Oximeter
K230172 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 204d
Cleared Aug 12, 2023
Pre-Filled Normal Saline Flush Syringe
K223584 · NGT
Anhui Tianyang Pharmaceutical Co., Ltd.
General Hospital · 254d
Cleared Aug 11, 2023
NOxBOXi Nitric Oxide Delivery System
K231823 · MRN
Linde Gas & Equipment, Inc.
Anesthesiology · 51d
Cleared Aug 11, 2023
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
K231696 · KLE
Prevest Denpro Limited
Dental · 60d
Cleared Aug 11, 2023
NITINEX Memory Compression Staple
K231493 · JDR
Vilex, LLC
Orthopedic · 80d
Cleared Aug 11, 2023
Powder Free White, Black, and Purple Nitrile Examination Glove
K231439 · LZA
S&S Glove Corporation
General Hospital · 86d
Cleared Aug 11, 2023
Erchonia FX-405
K231409 · NHN
Erchonia Corporation
Physical Medicine · 88d
Cleared Aug 11, 2023
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
K231408 · LZA
Shandong Intco Medical Products Co, Ltd.
General Hospital · 88d
Cleared Aug 11, 2023
Electronic Blood Pressure Monitor
K230642 · DXN
Dongguan Kangweile Electronic...
Cardiovascular · 156d
Cleared Aug 11, 2023
VersiHD with GuideMe software
K230632 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 157d
Cleared Aug 11, 2023
Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core...
K230626 · MWI
Ge Medical Systems Information...
Anesthesiology · 157d
Cleared Aug 11, 2023
Dr. pen Microneedling System
K230420 · QAI
Guangzhou Ekai Electronic Technology...
General & Plastic Surgery · 176d
Cleared Aug 11, 2023
PolyWear® Personal Protective Level 3 Gown
K230384 · QPC
PolyConversions, Inc.
General Hospital · 178d
Cleared Aug 11, 2023
PMT Expandable Cage (PMT EXP)
K230297 · MRW
Providence Medical Technology, Inc.
Orthopedic · 190d
Cleared Aug 11, 2023
NuEra Tight RF Family
K223856 · GEI
Bios S.R.L.
General & Plastic Surgery · 231d
Cleared Aug 11, 2023
eRapid Nebulizer System
K223840 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 232d
Cleared Aug 11, 2023
Carex Hybrid Personal Lubricant
K223519 · NUC
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 261d
Cleared Aug 11, 2023
Otsuka Digital Feedback Device-RW
K223463 · OZW
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 268d
Cleared Aug 11, 2023
BlueStar CGM insulin dose calculator
K222888 · QRX
Welldoc, Inc.
Chemistry · 322d
Cleared Aug 10, 2023
Aura 10 PET/CT
K231420 · QXL
Xeos Medical
Radiology · 86d
Cleared Aug 10, 2023
EnSite™ X EP System
K231415 · DQK
Abbott Medical
Cardiovascular · 86d
Cleared Aug 10, 2023
AirLife DuoTherm™ Humidification System
K231380 · BTT
Vyaire Medical, Inc.
Anesthesiology · 90d
Cleared Aug 10, 2023
ReliOn Premier BLU Blood Glucose Monitoring System
K230625 · NBW
I-Sens, Inc.
Chemistry · 157d