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
16153–16176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2021
Disposable Nitrile Examination Gloves
K211073 · LZA
Foshan Kangkang Biotechnology Co., Ltd.
General Hospital · 162d
Cleared Sep 21, 2021
KEYSTONE PEEK Cage System
K211689 · MAX
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 111d
Cleared Sep 21, 2021
Dayspring Lite
K212287 · JOW
Koya Medical, Inc.
Cardiovascular · 62d
Cleared Sep 21, 2021
T2
K212303 · OAS
Osstem Implant Co., Ltd.
Radiology · 60d
Cleared Sep 21, 2021
GEO Extremity and Ankle Plating System
K212334 · HRS
Gramercy Extremity Orthopedics, LLC
Orthopedic · 56d
Cleared Sep 21, 2021
Flyte
K212655 · HIR
Pelvital USA, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 21, 2021
Mariner Pedicle Screw System
K212692 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 27d
Cleared Sep 21, 2021
ProxiDiagnost N90
K212837 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 14d
Cleared Sep 20, 2021
CT-STOR
K201789 · NDS
Energy Delivery Solutions
Gastroenterology & Urology · 447d
Cleared Sep 20, 2021
ProFlex CO2 Laser Fiber
K203799 · GEX
Innovaquartz, LLC
General & Plastic Surgery · 266d
Cleared Sep 20, 2021
Disposable Sampler Inactivated Transport Media, Nest ITM
K210440 · QBD
Wuxi Nest Biotechnology Co., Ltd.
Microbiology · 220d
Cleared Sep 20, 2021
Kubtec Mozart Supra (XPERT 84) Radiography System
K210955 · MWP
Kub Technologies, Inc.
Radiology · 174d
Cleared Sep 20, 2021
Latex Examination Powder Free Gloves
K211477 · LYY
Aspen Glove Sdn. Bhd.
General Hospital · 131d
Cleared Sep 20, 2021
IPL Home Use Hair Removal Device
K211922 · OHT
Shenzhen Beauty Every Moment...
General & Plastic Surgery · 91d
Cleared Sep 20, 2021
Medline Digital Thermometer Non-Lubricated Probe Sheath
K211931 · FLL
Medline Industries, Inc.
General Hospital · 90d
Cleared Sep 20, 2021
TracStar LDP Large Distal Platform
K212224 · QJP
Imperative Care, Inc.
Neurology · 66d
Cleared Sep 20, 2021
SMILERS
K212961 · NXC
Biotech Dental Smilers, Sas
Dental · 4d
Cleared Sep 17, 2021
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
K201832 · HET
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 442d
Cleared Sep 17, 2021
Syntec Orthodontic Mini Screw Extended System
K202790 · OAT
Syntec Scientific Corporation
Dental · 360d
Cleared Sep 17, 2021
Uramix CuraWay Biopsy Needle
K203141 · KNW
Uramix, Inc.
General & Plastic Surgery · 332d
Cleared Sep 17, 2021
BreatheSuite MDI V1
K203155 · CAF
Breathesuite, Inc.
Anesthesiology · 330d
Cleared Sep 17, 2021
Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
K203418 · FXX
Ningbo Ouhan Medical Device Co., Ltd.
General Hospital · 302d
Cleared Sep 17, 2021
Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP...
K203762 · CCK
Covidien
Anesthesiology · 268d
Cleared Sep 17, 2021
Philips IntelliSite Pathology Solution
K203845 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 260d