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
27361–27384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2017
Orange Non Sterile Powder Free Nitrile Examination Gloves
K172642 · LZC
Central Medicare Sdn Bhd
General Hospital · 88d
Cleared Nov 28, 2017
Cefaly Dual
K173006 · PCC
Cefaly Technology
Neurology · 62d
Cleared Nov 28, 2017
LAP-iX Suction Irrigation
K173111 · HET
Sejong Medical Co., Ltd.
Obstetrics & Gynecology · 60d
Cleared Nov 28, 2017
Ankle Fusion Plating System
K173121 · HRS
In2bones Sas
Orthopedic · 60d
Cleared Nov 28, 2017
DuoFLEX Coil Suite
K173290 · MOS
Mr Instruments, Inc.
Radiology · 43d
Cleared Nov 28, 2017
3.0T 16ch Breast Coil
K173377 · MOS
Neocoil, LLC
Radiology · 29d
Cleared Nov 27, 2017
LED Curing Light
K161855 · EBZ
Monitex Industrial Co., Ltd.
Dental · 509d
Cleared Nov 27, 2017
Single Use Retrieval Nitinol Basket V
K170811 · LQR
Olympus Medical Systems Corp.
Gastroenterology & Urology · 255d
Cleared Nov 27, 2017
HEALIX ADVANCE KNOTLESS Anchor
K171114 · MAI
Medos International SARL
Orthopedic · 227d
Cleared CT Nov 27, 2017
PSLT for PASCAL Streamline
K171488 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 189d
Cleared Nov 27, 2017
Straumann Screw Retained Abutments
K171757 · NHA
Straumann USA, LLC (On Behalf of...
Dental · 166d
Cleared Nov 27, 2017
Devon 51
K172030 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 145d
Cleared Nov 27, 2017
CoLink View Plating System
K172300 · HRS
In2bones USA, LLC
Orthopedic · 119d
Cleared Nov 27, 2017
Cerafix Dura Substitute
K172603 · GXQ
Acera Surgical, Inc.
Neurology · 89d
Cleared Nov 27, 2017
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser...
K172687 · MCW
Spectranetics, Inc.
Cardiovascular · 82d
Cleared Nov 27, 2017
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original...
K173089 · MRC
Bausch & Lomb, Incorporated
Ophthalmic · 59d
Cleared Nov 27, 2017
VariAx 2 System
K173135 · HWC
Stryker GmbH
Orthopedic · 59d
Cleared Nov 24, 2017
True Function Adjustable Herbst Appliances
K170578 · LRK
True Function Laboratory, Inc.
Dental · 270d
Cleared Nov 24, 2017
Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray...
K170946 · OXO
Skanray Technologies Private Limited
Radiology · 239d
Cleared Nov 24, 2017
DIXI Medical Microdeep Depth Electrode
K170959 · GZL
Dixi Medical
Neurology · 238d
Cleared Nov 24, 2017
SALUS - Hygiene Instrument Reprocessing Container
K172292 · KCT
Scican , Ltd.
General Hospital · 116d
Cleared Nov 24, 2017
NuVasive AttraX Scaffold
K172497 · MQV
Nu Vasive, Incorporated
Orthopedic · 98d
Cleared Nov 24, 2017
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
K172678 · LZA
Shen Wei (Usa), Inc.
General Hospital · 80d
Cleared Nov 24, 2017
FilmArray RP2/RP2plus Control Panel
K173171 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 56d