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

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175,820 results
15481–15504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2021
Branchor Balloon Guide Catheter
K203723 · QJP
Asahi Intecc Co., Ltd.
Neurology · 354d
Cleared Dec 10, 2021
EXA
K203743 · LLZ
Konica Minolta Healthcare Americas, Inc.
Radiology · 353d
Cleared Dec 10, 2021
i8 Tanning Booth
K210004 · FTC
Ultrasun International B.V.
General & Plastic Surgery · 340d
Cleared Dec 10, 2021
VerSys Cemented Revision/Calcar
K210842 · JDI
Zimmer, Inc.
Orthopedic · 263d
Cleared Dec 10, 2021
UltraClear Fractional Laser System
K210847 · GEX
Fa International, LP
General & Plastic Surgery · 263d
Cleared Dec 10, 2021
Airvo Nebulizer Adapter
K211560 · CAF
Fisher & Paykel Healthcare Limited
Anesthesiology · 204d
Cleared Dec 10, 2021
Medline UNITE REFLEX Dynamic Discs
K211612 · HTN
Medline Industries, Inc.
Orthopedic · 198d
Cleared Dec 10, 2021
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30...
K211997 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 165d
Cleared Dec 10, 2021
X-Clever
K212137 · LLZ
Lg Electronics.Inc
Radiology · 155d
Cleared Dec 10, 2021
CINtec Histology
K212176 · PRB
Ventana Medical Systems, Inc.
Pathology · 151d
Cleared Dec 10, 2021
Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination...
K212349 · LZA
Medi Legion Sdn.Bhd
General Hospital · 135d
Cleared Dec 10, 2021
Comprehensive Humeral Fracture Positioning Sleeves
K212435 · KWS
Biomet, Inc.
Orthopedic · 128d
Cleared Dec 10, 2021
DESS Dental Smart Solutions
K212577 · NHA
Terrats Medical SL
Dental · 116d
Cleared Dec 10, 2021
ComfortPro Blue Nitrile Examination Gloves Powder Free
K212850 · LZA
Thai Rubber Industry Company Limited
General Hospital · 94d
Cleared Dec 10, 2021
Nitrile Examination Gloves
K212922 · LZA
Hsk Medical Apparatus Foshan China...
General Hospital · 87d
Cleared Dec 10, 2021
Vy Spine™ VySpan™ PCT System
K213394 · NKG
Vy Spine, LLC
Orthopedic · 56d
Cleared Dec 10, 2021
Invictus Spinal Fixation System
K213460 · NKB
Alphatec Spine, Inc.
Orthopedic · 44d
Cleared Dec 10, 2021
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar,...
K213543 · OBP
Neuronetics, Inc.
Neurology · 32d
Cleared Dec 10, 2021
JAZZ Solo sensor
K213637 · MUH
Jazz Imaging, LLC Dba Jazz Imaging
Radiology · 22d
Cleared Dec 10, 2021
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle...
K213638 · DYB
Argon Medical Devices
Cardiovascular · 22d
Cleared Dec 09, 2021
Infinity Acute Care System (IACS) Monitoring Solution
K201764 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 528d
Cleared Dec 09, 2021
AirStrip ONE Web Client with Alarm Communication Management (ACM)
K211949 · MSX
Airstrip Technologies, Inc.
Cardiovascular · 169d
Cleared Dec 09, 2021
LOSPA TKR System
K212034 · JWH
Corentec Co., Ltd.
Orthopedic · 163d
Cleared Dec 09, 2021
Plasma IQ
K212329 · GEI
Neauvia North America, Inc.
General & Plastic Surgery · 135d