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
10609–10632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2023
TrachCuff Cuff Controller
K220854 · BSK
Aw Technologies Aps
Anesthesiology · 387d
Cleared Apr 14, 2023
BTL-094
K221865 · ISA
BTL Industries, Inc.
Physical Medicine · 291d
Cleared Apr 14, 2023
LINK MobileLink Acetabular Cup System
K222066 · LPH
Waldemar Link GmbH & Co. KG
Orthopedic · 275d
Cleared Apr 14, 2023
OSPREY PERIPHERAL IV Catheter System
K223018 · FOZ
Skydance Vascular, Inc.
General Hospital · 197d
Cleared Apr 14, 2023
Compremium Compartment Compressibility Monitoring System (CPM#1)
K223509 · LXC
Compremium AG
Orthopedic · 143d
Cleared Apr 14, 2023
ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
K223566 · OOE
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 136d
Cleared Apr 14, 2023
EndoflipTM 300
K223705 · FFX
Covidien, LLC
Gastroenterology & Urology · 123d
Cleared Apr 14, 2023
N9+
K223785 · DQD
Nonagon , Ltd.
Cardiovascular · 119d
Cleared Apr 14, 2023
Dragonfly OpStar™ Imaging Catheter
K230411 · DQO
Abbott Medical
Cardiovascular · 58d
Cleared Apr 14, 2023
AutoContour Model RADAC V3
K230685 · QKB
Radformation, Inc.
Radiology · 32d
Cleared Apr 13, 2023
AUTION MAX AX-4060 Urinalysis System
K193514 · JIL
Arkray, Inc.
Chemistry · 1211d
Cleared Apr 13, 2023
CerebralGo Plus
K213986 · QIH
Yukun (Beijing) Technology Co., Ltd.
Radiology · 479d
Cleared Apr 13, 2023
ALPCO Calprotectin Immunoturbidimetric Assay
K220763 · NXO
ALPCO
Immunology · 393d
Cleared Apr 13, 2023
Stratus Infusion Catheter
K222185 · NPG
Intervene, Inc.
Cardiovascular · 265d
Cleared Apr 13, 2023
CIRRUS HD-OCT
K222200 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 262d
Cleared Apr 13, 2023
Sterile Nitrile Surgical Gloves Powder Free
K222350 · KGO
Jr Engineering & Medical Technologies...
General Hospital · 253d
Cleared Apr 13, 2023
Point implant system
K222738 · DZE
Pointnix Co., Ltd.
Dental · 216d
Cleared Apr 13, 2023
FreeStyle Libre 3 Continuous Glucose Monitoring System
K223435 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 150d
Cleared Apr 13, 2023
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
K223879 · DTR
Quara S.R.L.
Cardiovascular · 107d
Cleared Apr 13, 2023
ADSEAL Plus
K230010 · KIF
Meta Biomed Co., Ltd.
Dental · 100d
Cleared Apr 13, 2023
Trusana™
K230098 · EBI
Myerson, LLC
Dental · 90d
Cleared Apr 13, 2023
DESS Dental Smart Solutions
K230143 · NHA
Terrats Medical SL
Dental · 85d
Cleared Apr 13, 2023
Ezra Flash
K230264 · LLZ
Ezra Ai, Inc.
Radiology · 72d
Cleared Apr 13, 2023
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C)
K230387 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 58d