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
13585–13608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2022
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K212620 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 267d
Cleared May 12, 2022
Laser hair growth helmet
K213025 · OAP
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 233d
Cleared May 12, 2022
Universal Pilot Guidance Instrument System
K213491 · OLO
Ctl Medical Corporation
Orthopedic · 192d
Cleared May 12, 2022
Sterile Hypodermic Syringes for Single Use
K213811 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 156d
Cleared May 12, 2022
Saige-Dx
K220105 · QDQ
DeepHealth, Inc.
Radiology · 120d
Cleared May 12, 2022
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free...
K220118 · LZA
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 118d
Cleared May 12, 2022
ANSiStim-PP
K220397 · NHI
Dyansys, Inc.
Neurology · 90d
Cleared May 12, 2022
Capsulo
K220430 · HQF
Quantel Medical
Ophthalmic · 86d
Cleared May 12, 2022
Synguard Nitrile Exam Glove
K220442 · LZA
Tianjin Aoshang Outdoor Equipment...
General Hospital · 85d
Cleared May 12, 2022
Hand Trauma Screw System
K220723 · HWC
Skeletal Dynamics, Inc.
Orthopedic · 59d
Cleared May 12, 2022
Motive Knee Wrap
K220738 · IPF
Cymedica Orthopedics, Inc.
Physical Medicine · 59d
Cleared May 12, 2022
Power Wheelchair, W5907 (Q50 R Carbon)
K220740 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 59d
Cleared May 12, 2022
Power Wheelchair (N5515B)
K220747 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 59d
Cleared May 12, 2022
IPL Home Use Hair Removal Device
K221001 · OHT
Shenzhen Beauty Every Moment...
General & Plastic Surgery · 38d
Cleared May 11, 2022
Durex Condom with Benzocaine
K211152 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 387d
Cleared May 11, 2022
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System),...
K212909 · IYE
Macromedics BV
Radiology · 240d
Cleared May 11, 2022
Procedure Mask, Surgical Mask
K213001 · FXX
A Plus International, Inc.
General Hospital · 233d
Cleared May 11, 2022
Plus Medical Cover Gown
K213177 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 225d
Cleared May 11, 2022
Wireless EEG System
K213299 · OLT
Pascall Systems, Inc.
Neurology · 222d
Cleared May 11, 2022
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K220250 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 100d
Cleared May 11, 2022
Versana Balance
K220446 · IYN
GE Medical Systems Ultrasound and...
Radiology · 84d
Cleared May 11, 2022
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K220587 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 71d
Cleared May 11, 2022
Disposable Barrier Sleeves
K220662 · PEM
Premium Plus (Dongguan) Limited
Dental · 65d
Cleared May 10, 2022
BD CTGCTV2
K210585 · QEP
Becton, Dickinson and Company
Microbiology · 438d