FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
28057–28080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2017
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade...
K162190 · MUH
Villa Sistemi Medicali S.P.A.
Radiology · 336d
Cleared Jul 06, 2017
CO2 Laser Therapy Systems
K162398 · ONG
Beijing Sincoheren Science and...
General & Plastic Surgery · 314d
Cleared Jul 06, 2017
ClearPath Aligner
K162609 · NXC
Clearpath Orthodontics, Ltd.
Dental · 290d
Cleared Jul 06, 2017
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System...
K170143 · NBW
Bionime Corporation
Chemistry · 170d
Cleared Jul 06, 2017
Spider Cervical Plating System
K170224 · KWQ
X-Spine Systems, Inc.
Orthopedic · 162d
Cleared Jul 06, 2017
Endoskeleton TO Interbody Fusion Device (IBD)
K170399 · MAX
Titan Spine, LLC
Orthopedic · 147d
Cleared Jul 06, 2017
Tempus Pro Patient Monitor
K170567 · MHX
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 129d
Cleared Jul 06, 2017
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent...
K170587 · JIN
ACON Laboratories, Inc.
Chemistry · 128d
Cleared Jul 06, 2017
PSA Cable
K170815 · DTC
Boston Scientific Corporation
Cardiovascular · 111d
Cleared Jul 06, 2017
Site~Rite Halcyon Diagnostic Ultrasound System
K170870 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 105d
Cleared Jul 06, 2017
CRESCENT™ Spinal System
K171031 · MAX
Medtronic Sofamor Danek
Orthopedic · 91d
Cleared Jul 06, 2017
Philips BlueControl
K171055 · ONE
Philips Electronics Nederland B.V.
General & Plastic Surgery · 87d
Cleared Jul 06, 2017
Dermal Cooling System
K171398 · GEH
R2 Dermatology ,Inc
General & Plastic Surgery · 55d
Cleared Jul 06, 2017
MPR2 logO DATALOGGER
K171666 · GWM
Raumedic AG
Neurology · 31d
Cleared Jul 05, 2017
Leica FL560
K170239 · IZI
Leica Microsystems (Schweiz) AG
Radiology · 160d
Cleared Jul 05, 2017
TOKUYAMA CUREGRACE
K170549 · EBI
Tokuyama Dental Corporation
Dental · 131d
Cleared Jul 05, 2017
Eclipse Treatment Planning System
K170969 · MUJ
Varian Medical Systems, Inc.
Radiology · 96d
Cleared Jul 05, 2017
g.Nautilus PRO
K171669 · GWL
G.Tec Medical Engineering GmbH
Neurology · 30d
Cleared Jul 03, 2017
Enterprise Imaging XERO Viewer 8.1
K170434 · LLZ
Agfa Healthcare N.V.
Radiology · 140d
Cleared Jul 03, 2017
Equashield Closed System drug Transfer Device (CSTD)
K170706 · ONB
Equashield Medical , Ltd.
General Hospital · 117d
Cleared Jul 03, 2017
Gemini-C Hybrid Cervical Interbody System
K170844 · ODP
Osseus Fusion Systems, LLC
Orthopedic · 104d
Cleared Jul 03, 2017
DigniCap Scalp Cooling System
K170871 · PMC
Dignitana AB
General & Plastic Surgery · 102d
Cleared Jul 03, 2017
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
K170955 · NLQ
Surgical Instrument Service and...
General & Plastic Surgery · 94d
Cleared Jul 03, 2017
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical...
K170974 · OYE
Becton, Dickinson and Company
Immunology · 91d