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
15433–15456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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 CT 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
Cleared Dec 14, 2021
Aspira Peritoneal Drainage System
K212675 · PNG
Merit Medical Systems, Inc.
Gastroenterology & Urology · 112d
Cleared Dec 14, 2021
TimeWaver Frequency
K212832 · IPF
Timewaver Production GmbH
Physical Medicine · 98d
Cleared Dec 14, 2021
SeaSpine WaveForm C Interbody System
K212904 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 92d
Cleared Dec 14, 2021
MRIdian Linac System
K212958 · IYE
Viewray, Incorporated
Radiology · 89d
Cleared Dec 14, 2021
Nitrile Examination Gloves (Powder free, Blue)
K213029 · LZA
Weihai Hongyu Nonwoven Fabric...
General Hospital · 84d
Cleared Dec 14, 2021
EkoSonic Endovascular Device, EKOS+ Endovascular Device
K213422 · QEY
Boston Scientific Corporation
Cardiovascular · 55d
Cleared Dec 13, 2021
Surgical face mask: F-Y1-A
K202794 · FXX
Jiande Chaomei Daily Chemicals Co., Ltd.
General Hospital · 446d
Cleared Dec 13, 2021
Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color
K210388 · LZA
Mexpo International, Inc.
General Hospital · 307d