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
28633–28656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 2017
Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic...
K163648 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 196d
Cleared Jul 07, 2017
Models 3543A, 4343A, 2929A and A843B
K170480 · MQB
Shanghai PZ Medical Technolgoy Co., Ltd.
Radiology · 141d
Cleared Jul 07, 2017
Anorganic Bone Mineral in Delivery Applicator
K170541 · NPM
Collagen Matrix, Inc.
Dental · 134d
Cleared Jul 07, 2017
RX NC Takeru PTCA Balloon Dilatation Catheter
K170941 · LOX
KANEKA Corporation
Cardiovascular · 99d
Cleared Jul 07, 2017
SeaSpine Cambria System
K171046 · ODP
SeaSpine Orthopedics Corporation
Orthopedic · 91d
Cleared Jul 07, 2017
ZELTIQ CoolSculpting System
K171069 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 88d
Cleared Jul 07, 2017
AXON IR Heat Lamp
K171087 · ILY
Crystal Medtech, LLC
Physical Medicine · 86d
Cleared Jul 07, 2017
EMG Blue Nitrile Examination Gloves Powder free with tested for use with...
K171339 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 60d
Cleared Jul 07, 2017
Hammertoe Correction System
K171448 · HWC
Life Spine, Inc.
Orthopedic · 51d
Cleared Jul 07, 2017
Interject Injection Therapy Needle Catheter
K171454 · FBK
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Jul 07, 2017
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
K171461 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 50d
Cleared Jul 07, 2017
Smart Syringe
K171698 · DXT
Osprey Medical, Inc.
Cardiovascular · 29d
Cleared Jul 07, 2017
Thunder, Thunder VT, Thunder HR
K171711 · GEX
Quanta System Spa
General & Plastic Surgery · 28d
Cleared Jul 06, 2017
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
K161394 · LEJ
Sportarredo Group S.C.
General & Plastic Surgery · 413d
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