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
18385–18408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2020
SMR 140° Reverse Humeral Body
K201905 · MBF
Lima Corporate S.P.A.
Orthopedic · 161d
Cleared Dec 17, 2020
Blue Sky Bio TAD
K201919 · OAT
Blue Sky Bio, LLC
Dental · 160d
Cleared Dec 17, 2020
KARL STORZ ICG Imaging System
K202925 · OWN
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 79d
Cleared Dec 17, 2020
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
K203004 · DXT
Acist Medical Systems, Inc.
General Hospital · 77d
Cleared Dec 17, 2020
ARx Illiac Spinal Screw System
K203163 · NKB
Life Spine, Inc.
Orthopedic · 55d
Cleared Dec 17, 2020
PERLA TL Posterior Osteosynthesis System
K203222 · NKB
Spineart
Orthopedic · 45d
Cleared Dec 17, 2020
Emprint SX Ablation Platform with Thermosphere Technology
K203303 · NEY
Covidien, LLC
General & Plastic Surgery · 38d
Cleared Dec 16, 2020
CREED™ Cannulated Screws
K200291 · HWC
Glw Medical, Inc.
Orthopedic · 315d
Cleared Dec 16, 2020
Lucero Medical Cervical Cage System
K200549 · ODP
Lucero Medical, LLC
Orthopedic · 288d
Cleared Dec 16, 2020
NRFit® Caps, Male and Female Neuraxial Tip Caps
K201031 · QEH
International Medical Industries, Inc.
General Hospital · 240d
Cleared Dec 16, 2020
Pasteur Pipette 3mL, Pasteur Pipette 1mL
K201213 · MQK
Hertart Aps
Obstetrics & Gynecology · 225d
Cleared Dec 16, 2020
Disposable Stone Extraction basket
K201509 · LQR
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 194d
Cleared Dec 16, 2020
dermalux Flex MD
K202028 · ILY
Aesthetic Technology, Ltd.
General & Plastic Surgery · 147d
Cleared Dec 16, 2020
Medical Surgical Mask
K202029 · FXX
Beijing Biosis Healing Biolog Ical...
General Hospital · 147d
Cleared Dec 16, 2020
CreoDent Solidex Customized Abutment and Screw
K202095 · NHA
Creodent Prosthetics, Ltd.
Dental · 140d
Cleared Dec 16, 2020
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder...
K202289 · KWS
Stryker GmbH
Orthopedic · 126d
Cleared Dec 16, 2020
HydroMARK Breast Biopsy Site Markers
K203097 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 63d
Cleared Dec 16, 2020
Arthrex DynaNite Nitinol Staples
K203180 · JDR
Arthrex, Inc.
Orthopedic · 51d
Cleared Dec 16, 2020
Longeviti ClearFit Cranial Implant
K203349 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 33d
Cleared Dec 16, 2020
DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP...
K203414 · HRS
DePuy Synthes
Orthopedic · 27d
Cleared Dec 15, 2020
Fixone All Suture Anchor
K192709 · MBI
Aju Pharm Co., Ltd.
Orthopedic · 445d
Cleared Dec 15, 2020
308nm Excimer System
K200971 · FTC
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 246d
Cleared Dec 15, 2020
WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA...
K201755 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 169d
Cleared Dec 15, 2020
X-Tack Endoscopic HeliX Tacking System
K201808 · PKL
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 167d