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

Filters: Cleared only ×
175,820 results
22561–22584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2019
Impress Angiographic Catheter
K191608 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Jul 16, 2019
Orthophos S
K191616 · OAS
Dentsply Sirona
Radiology · 28d
Cleared Jul 15, 2019
UNiD Patient-matched PLIF cage
K182158 · MAX
Medicrea International SA
Orthopedic · 340d
Cleared Jul 15, 2019
A.B. DENTAL DEVICES Dental Implants System
K182455 · NHA
A.B. Dental Device , Ltd.
Dental · 311d
Cleared Jul 15, 2019
Rael Tampon
K182814 · HEB
Rael, Inc.
Obstetrics & Gynecology · 285d
Cleared Jul 15, 2019
MicroPort CoCr Femoral Heads
K190123 · LPH
Microport Orthopedics, Inc.
Orthopedic · 171d
Cleared Jul 15, 2019
087 Balloon Guide Catheter System
K190749 · DQY
Q'Apel
Neurology · 112d
Cleared Jul 15, 2019
Lyra
K191372 · EWO
Interacoustics A/S
Ear, Nose, Throat · 54d
Cleared Jul 15, 2019
Optilite IgM Kit
K191635 · CFN
The Binding Site Group , Ltd.
Immunology · 26d
Cleared CT Jul 14, 2019
DROWZLE
K173974 · MNR
Resonea, Inc.
Anesthesiology · 562d
Cleared Jul 14, 2019
Modus Nav
K183325 · HAW
Synaptive Medical, Inc.
Neurology · 226d
Cleared Jul 12, 2019
Osstem Abutment System
K182091 · NHA
Osstem Implant Co., Ltd.
Dental · 343d
Cleared Jul 12, 2019
Novidia Bulk Fill Flow Composite
K182714 · EBF
Nobio , Ltd.
Dental · 288d
Cleared Jul 12, 2019
PerioLase Nd:YAG Pulsed Dental Laser System
K182930 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 263d
Cleared Jul 12, 2019
AMSafe(R) Pre-Filled Normal Saline Flush Syringe
K183473 · NGT
Amsino International, Inc.
General Hospital · 210d
Cleared Jul 12, 2019
VERITON CT whole body SPECT/CT system
K190457 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 137d
Cleared Jul 12, 2019
Ambu aScope 4 RhinoLaryngo Intervention
K190972 · EOB
Ambu A/S
Ear, Nose, Throat · 88d
Cleared Jul 12, 2019
Radial Medical Compression System
K190976 · JOW
Radial Medical, Inc.
Cardiovascular · 88d
Cleared Jul 12, 2019
SureForm 45 Curved Tip, SureForm 45 Gray Reload
K190999 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 87d
Cleared Jul 12, 2019
MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic...
K191050 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jul 12, 2019
Stryker CrossFlow Integrated Arthroscopy Pump
K191259 · HRX
Stryker Corp.
General & Plastic Surgery · 63d
Cleared Jul 12, 2019
Wearable Device, Wearable Package
K191272 · MSX
Current Health , Ltd.
Cardiovascular · 60d
Cleared Jul 12, 2019
Remington Medical, Inc. Automatic Cutting Needle (NAC)
K191315 · KNW
Remington Medical, Inc.
General & Plastic Surgery · 58d
Cleared Jul 12, 2019
StitchKit
K191317 · NBY
Origami Surgical
General & Plastic Surgery · 58d