FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13441–13464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 2022
Laser Hair Growth Comb
K213027 · OAP
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 247d
Cleared May 26, 2022
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta...
K213171 · HIH
Meditrina, Inc.
Obstetrics & Gynecology · 240d
Cleared May 26, 2022
AMADEO, M-UK1015 (incl. attachments and accessories)
K213221 · ERL
W&H Dentalwerk Buermoss GmbH
Dental · 239d
Cleared May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K213996 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 157d
Cleared May 26, 2022
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
K214074 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 150d
Cleared May 26, 2022
iFuse Bedrock Granite™ Implant System
K220195 · OUR
SI-BONE, Inc.
Orthopedic · 122d
Cleared May 26, 2022
Sterile Nitrile Powder Free Examination Gloves Tested For Use With...
K220249 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 115d
Cleared May 26, 2022
Astroglide Ultra Gentle Gel
K220355 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 107d
Cleared May 26, 2022
Powder Free Nitrile Examination Gloves, Blue, Tested for use with...
K220545 · LZC
Hl Rubber Industries Sdn Bhd
General Hospital · 90d
Cleared May 26, 2022
Wearable Breast Pump (Model S9)
K220596 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 86d
Cleared May 26, 2022
Disposable Surgical Face Mask (FM-34EE,FM-44EE)
K220597 · FXX
Qingdao Bestex Rubber & Plastic...
General Hospital · 86d
Cleared May 26, 2022
Barrigel Injectable Gel
K220641 · OVB
Palette Life Sciences
Radiology · 83d
Cleared May 25, 2022
restor3d MTP Implant
K201393 · KWD
Restor3D, Inc.
Orthopedic · 728d
Cleared May 25, 2022
OptiComp
K202920 · EBF
Pac-Dent, Inc.
Dental · 603d
Cleared May 25, 2022
CRYO Arctic, CRYO Penguin
K203661 · MLY
Cryoscience North America, Inc.
Physical Medicine · 526d
Cleared May 25, 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · OWQ
Innovative Health, LLC
Cardiovascular · 447d
Cleared May 25, 2022
Well-life TM Pen Needles, Well-life TM Safety Pen Needles
K210748 · FMI
W. L. Med Co., Ltd.
General Hospital · 439d
Cleared May 25, 2022
Renuvion Dermal Handpiece, Renuvion Dermal System
K211652 · GEI
Apyx Medical Corporation(Formerly...
General & Plastic Surgery · 362d
Cleared May 25, 2022
Disposable Sterilized Latex Surgical Gloves
K211953 · KGO
Jiangxi Kemei Medical Apparatus &...
General Hospital · 336d
Cleared May 25, 2022
Micro-current facial cold and hot service (model: TPML-100)
K213039 · OLP
Li-Tek Electronics Technology C0., Ltd.
General & Plastic Surgery · 245d
Cleared May 25, 2022
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
K213485 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 208d
Cleared May 25, 2022
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and...
K214046 · GCJ
Stryker
General & Plastic Surgery · 149d
Cleared May 25, 2022
Single Use Ureteral Access Sheath
K220065 · FED
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 135d
Cleared May 25, 2022
LDV((Low Dead Volume )Syringe
K220083 · QNQ
Anhui Hongyu Wuzhou Medical...
General Hospital · 135d