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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14329–14352 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2021
Will3D
K211114 · LLZ
Hdx Will Corp.
Radiology · 245d
Cleared Dec 15, 2021
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution...
K211539 · NGZ
Thermo Fisher Scientific
Microbiology · 211d
Cleared Dec 15, 2021
HealthPPT
K211803 · QFM
Zebra Medical Vision, Ltd.
Radiology · 187d
Cleared Dec 15, 2021
Revolution Peripheral Atherectomy System
K212351 · MCW
Rex Medical, L.P.
Cardiovascular · 139d
Cleared Dec 15, 2021
Surgical Face Mask (Non-sterile)
K212398 · FXX
Hubei Kimsoul Industrial Co., Ltd.
General Hospital · 135d
Cleared Dec 15, 2021
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion...
K212781 · PEK
Spinal Simplicity, LLC
Orthopedic · 105d
Cleared Dec 15, 2021
Merit Siege Vascular Plug
K212817 · KRD
Merit Medical System, Inc.
Cardiovascular · 103d
Cleared Dec 15, 2021
Surgical Gown, Reinforced Surgical Gown
K212861 · FYA
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 98d
Cleared Dec 15, 2021
SIMPACT Sacroiliac Joint Fixation System
K212903 · OUR
Life Spine, Inc.
Orthopedic · 93d
Cleared Dec 15, 2021
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212919 · LZA
Jiujiang Taixin Technology Co., Ltd.
General Hospital · 92d
Cleared Dec 15, 2021
Disposable Surgical Mask
K212944 · FXX
Heilongjiang Yinjia Medical Equipment...
General Hospital · 93d
Cleared Dec 15, 2021
Cellusheet, Cellufil
K213092 · KGN
Human Biosciences, Inc.
General & Plastic Surgery · 82d
Cleared Dec 15, 2021
RT-Mind-AI
K213155 · QKB
Medmind Technology Co., Ltd.
Radiology · 78d
Cleared Dec 15, 2021
Insignia™ Anterior Cervical Plate System
K213443 · KWQ
Alphatec Spine, Inc.
Orthopedic · 51d
Cleared Dec 15, 2021
Chocolate PTA Balloon Catheter
K213631 · LIT
Medtronic, Inc.
Cardiovascular · 28d
Cleared Dec 15, 2021
Serranator PTA Serration Balloon Catheter
K213728 · PNO
Cagent Vascular, LLC
Cardiovascular · 19d
Cleared Dec 14, 2021
Blood Collection Needles
K200932 · FMI
Vacutest Kima Srl
General Hospital · 616d
Cleared Dec 14, 2021
S2 Pigment Removal System
K202848 · GEX
Lightsense Technologies, Ltd.
General & Plastic Surgery · 445d
Cleared Dec 14, 2021
PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use...
K203716 · QFC
Smith and Nephew Medical Limited
General & Plastic Surgery · 358d
Cleared Dec 14, 2021
Instant 20s Indicator
K210481 · MTC
True Indicating, LLC
General & Plastic Surgery · 298d
Cleared Dec 14, 2021
Surgical Mask
K210744 · FXX
Chongqing PA Xijia Biotechnology Co.,...
General Hospital · 277d
Cleared Dec 14, 2021
ZEPTO Precision Capsulotomy System
K210827 · PUL
Centricity Vision, Inc.
Ophthalmic · 270d
Cleared Dec 14, 2021
DESS Dental Implants
K212538 · DZE
Terrats Medical SL
Dental · 124d
Cleared Dec 14, 2021
Surgical Face Mask
K212574 · FXX
Xiantao Deming Healthcare Products...
General Hospital · 120d