FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
11377–11400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2023
Vinyl examination gloves
K230046 · LYZ
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 78d
Cleared Mar 25, 2023
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use,...
K220644 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 386d
Cleared Mar 24, 2023
SmartMTA Capsule
K230797 · KIF
Sprig Oral Health Technologies, Inc.
Dental · 2d
Cleared Mar 24, 2023
EVA5 Insufflator
K230474 · FCX
Palliare , Ltd.
Gastroenterology & Urology · 30d
Cleared Mar 24, 2023
Quantra Hemostasis Analyzer
K230461 · QFR
Hemosonics, LLC
Hematology · 31d
Cleared Mar 24, 2023
3 Series NeoLux
K230382 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 39d
Cleared Mar 24, 2023
Entarik Feeding Tube System
K230206 · KNT
Gravitas Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Mar 24, 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for...
K230002 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 80d
Cleared Mar 24, 2023
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting...
K223803 · QPP
Canary Medical USA, LLC
Orthopedic · 95d
Cleared Mar 24, 2023
Blood Collection Needle (with/without Needle Holder)
K223323 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 144d
Cleared Mar 24, 2023
Medline Surgical Face Mask and Medline Procedural Face Mask
K223236 · FXX
Medline Industries, LP
General Hospital · 156d
Cleared Mar 24, 2023
BD Texium™ Closed Male Luer
K223076 · ONB
Care Fusion
General Hospital · 175d
Cleared Mar 24, 2023
BD BACTEC™ Plus Aerobic/F Culture Vials
K222591 · MDB
Becton, Dickinson and Company
Microbiology · 210d
Cleared Mar 24, 2023
BD BACTEC™ Myco/F Lytic Culture Vials
K222559 · MDB
Becton, Dickinson and Company
Microbiology · 212d
Cleared Mar 24, 2023
Starly pad
K221589 · GXY
Shenzhen Xingyuanli Technology Co., Ltd.
Neurology · 296d
Cleared Mar 24, 2023
BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button...
K220212 · JKA
Becton, Dickinson and Company
General Hospital · 422d
Cleared Mar 23, 2023
Swedge™ Pedicle Screw Fixation System
K230482 · NKB
Spinal Resources, Inc.
Orthopedic · 29d
Cleared Mar 23, 2023
Disposable Medical Nitrile Examination Gloves
K223895 · LZA
Hebei Titans Hongsen Medical...
General Hospital · 85d
Cleared Mar 23, 2023
ATEC Lateral Navigation Instruments
K223765 · OLO
Alphatec Spine, Inc.
Orthopedic · 98d
Cleared Mar 23, 2023
ClosureFast™ Endovenous Radiofrequency Ablation Catheter
K223488 · GEI
Medtronic, Inc.
General & Plastic Surgery · 122d
Cleared Mar 23, 2023
SpaceFlex Acetabular Cup
K223441 · KWY
G21, S.R.L.
Orthopedic · 129d
Cleared Mar 23, 2023
Triever16 Curve
K223419 · QEW
Inari Medical
Cardiovascular · 133d
Cleared Mar 23, 2023
3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and...
K222859 · OMP
3M
General & Plastic Surgery · 182d
Cleared Mar 23, 2023
Sterilized Latex Surgical Gloves
K222620 · KGO
Suzhou Colour-Way New Material Co., Ltd.
General Hospital · 205d