FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
10897–10920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2023
Arrow 0.2 Micron Flat Filter, GVS
K222341 · CAZ
Arrow International, LLC
Anesthesiology · 194d
Cleared Feb 13, 2023
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K223186 · QEW
Penumbra, Inc.
Cardiovascular · 124d
Cleared Feb 13, 2023
Prevena Plus 125 Therapy Unit
K223263 · QFC
3M
General & Plastic Surgery · 112d
Cleared Feb 13, 2023
NeatNick Heel Safety Lancet
K223370 · FMK
Facet Technologies, LLC
General & Plastic Surgery · 101d
Cleared Feb 13, 2023
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K223387 · IYN
Samsung Medison Co., Ltd.
Radiology · 98d
Cleared Feb 13, 2023
SIGNA Victor
K223439 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 91d
Cleared Feb 13, 2023
AmeriWater MediQA Reverse Osmosis System (MSP3HF)
K223656 · FIP
AmeriWater, LLC
Gastroenterology & Urology · 69d
Cleared Feb 13, 2023
OIC Intramedullary Screw System
K223761 · HWC
Orthopaedic Implant Company
Orthopedic · 60d
Cleared Feb 13, 2023
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software,...
K223767 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 60d
Cleared Feb 13, 2023
EMPOWR™ blade stem
K223779 · LPH
Encore Medical, LLC
Orthopedic · 59d
Cleared Feb 13, 2023
Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested...
K223859 · LZA
Rhino Health, Inc.
General Hospital · 52d
Cleared Feb 13, 2023
syngo.via View&GO VA40A
K230196 · LLZ
Siemens Healthcare GmbH
Radiology · 19d
Cleared Feb 13, 2023
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select...
K230207 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 19d
Cleared Feb 12, 2023
SMILE
K213629 · QGL
Nu Eyne Co., Ltd.
Neurology · 452d
Cleared Feb 10, 2023
RENASYS™-WF White Foam NPWT Dressing Small
K213853 · OMP
Smith and Nephew Medical Limited
General & Plastic Surgery · 427d
Cleared Feb 10, 2023
SEJONG Surgical Gown Soft
K220435 · FYA
Sejong Healthcare Co., Ltd.
General Hospital · 361d
Cleared Feb 10, 2023
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
K220657 · FLL
Zhejiang Rongsheng Industrial Co., Ltd.
General Hospital · 340d
Cleared Feb 10, 2023
ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
K220715 · MQL
Artsmedia Denmark Aps
Obstetrics & Gynecology · 336d
Cleared Feb 10, 2023
DiLumen C1, EZ1 and Tool Mount
K221452 · FDF
Lumendi, LLC
Gastroenterology & Urology · 268d
Cleared Feb 10, 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
K221474 · FLE
Primus Sterilizer Company, LLC
General Hospital · 266d
Cleared Feb 10, 2023
Perifit
K221476 · HIR
X6 Innovations
Gastroenterology & Urology · 266d
Cleared Feb 10, 2023
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32...
K222129 · LZA
Top Glove Medical (Thailand) Co., Ltd.
General Hospital · 207d
Cleared Feb 10, 2023
Glass Ceramics
K222513 · EIH
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 175d
Cleared Feb 10, 2023
S90 Exp Series Digital Color Doppler Ultrasound System
K222596 · IYN
Sonoscape Medical Corp.
Radiology · 168d