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
14185–14208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 10, 2022
Overjet Caries Assist
K212519 · MYN
Overjet, Inc.
Radiology · 273d
Cleared May 10, 2022
Needle Free Connector
K213004 · FPA
Medcaptain Life Science Co., Ltd.
General Hospital · 232d
Cleared May 10, 2022
Dental diode laser
K214008 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 139d
Cleared May 10, 2022
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220427 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220428 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
K220711 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 60d
Cleared May 10, 2022
inHEART MODELS
K220727 · LLZ
Inheart, Sas
Radiology · 57d
Cleared May 10, 2022
Identity Imprint Knee Replacement System (including Identity Imprint...
K221059 · JWH
Conformis, Inc.
Orthopedic · 29d
Cleared May 10, 2022
RadiForce MX243W
K221136 · PGY
Eizo Corporation
Radiology · 21d
Cleared May 09, 2022
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
K203429 · NJR
Cepheid
Microbiology · 535d