FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14377–14400 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2021
Iconic Nitrile Glove
K212182 · LZA
Iconic Medicare Sdn Bhd
General Hospital · 151d
Cleared Dec 11, 2021
Nitrile Gloves (Model: NE01)
K212840 · LZA
Byd Auto Industry Company Limited
General Hospital · 95d
Cleared Dec 11, 2021
Medical Surgical Mask
K212867 · FXX
Nanchang Kanghua Health Materials...
General Hospital · 94d
Cleared Dec 11, 2021
Disposable Vinyl/Nitrile Blend Medical Examination Gloves
K212899 · LYZ
Bytech Dongtai Co., Ltd.
General Hospital · 89d
Cleared Dec 10, 2021
Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26,...
K201600 · FLL
Kangfu Medical Equipment Factory
General Hospital · 546d
Cleared Dec 10, 2021
AMG PMP Infant
K202510 · DTZ
Eurosets S.R.L
Cardiovascular · 466d
Cleared Dec 10, 2021
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level...
K203539 · FYA
Unicoglobal, Inc.
General Hospital · 372d
Cleared Dec 10, 2021
Dental Scaler and Air Polisher
K203615 · ELC
Guilin Woodpecker Medical Instrument...
Dental · 365d
Cleared Dec 10, 2021
Branchor Balloon Guide Catheter
K203723 · QJP
Asahi Intecc Co., Ltd.
Neurology · 354d
Cleared Dec 10, 2021
EXA
K203743 · LLZ
Konica Minolta Healthcare Americas, Inc.
Radiology · 353d
Cleared Dec 10, 2021
i8 Tanning Booth
K210004 · FTC
Ultrasun International B.V.
General & Plastic Surgery · 340d
Cleared Dec 10, 2021
VerSys Cemented Revision/Calcar
K210842 · JDI
Zimmer, Inc.
Orthopedic · 263d
Cleared Dec 10, 2021
UltraClear Fractional Laser System
K210847 · GEX
Fa International, LP
General & Plastic Surgery · 263d
Cleared Dec 10, 2021
Airvo Nebulizer Adapter
K211560 · CAF
Fisher & Paykel Healthcare Limited
Anesthesiology · 204d
Cleared Dec 10, 2021
Medline UNITE REFLEX Dynamic Discs
K211612 · HTN
Medline Industries, Inc.
Orthopedic · 198d
Cleared Dec 10, 2021
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30...
K211997 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 165d
Cleared Dec 10, 2021
X-Clever
K212137 · LLZ
Lg Electronics.Inc
Radiology · 155d
Cleared Dec 10, 2021
CINtec Histology
K212176 · PRB
Ventana Medical Systems, Inc.
Pathology · 151d
Cleared Dec 10, 2021
Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination...
K212349 · LZA
Medi Legion Sdn.Bhd
General Hospital · 135d
Cleared Dec 10, 2021
Comprehensive Humeral Fracture Positioning Sleeves
K212435 · KWS
Biomet, Inc.
Orthopedic · 128d
Cleared Dec 10, 2021
DESS Dental Smart Solutions
K212577 · NHA
Terrats Medical SL
Dental · 116d
Cleared Dec 10, 2021
ComfortPro Blue Nitrile Examination Gloves Powder Free
K212850 · LZA
Thai Rubber Industry Company Limited
General Hospital · 94d
Cleared Dec 10, 2021
Nitrile Examination Gloves
K212922 · LZA
Hsk Medical Apparatus Foshan China...
General Hospital · 87d
Cleared Dec 10, 2021
Vy Spine™ VySpan™ PCT System
K213394 · NKG
Vy Spine, LLC
Orthopedic · 56d