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
19681–19704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2020
LOGIQ E10
K200158 · IYN
GE Medical Systems Ultrasound &...
Radiology · 86d
Cleared Apr 17, 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex...
K200257 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 74d
Cleared Apr 17, 2020
ProLift Lateral Fixated
K200338 · OVD
Life Spine, Inc.
Orthopedic · 66d
Cleared Apr 17, 2020
Kyocera Bipolar Hip System
K200709 · KWY
Kyocera Medical Technologies, Inc.
Orthopedic · 30d
Cleared Apr 17, 2020
Rumble Tuff Electric Breast Pump
K200712 · HGX
A Cute Baby, Inc.
Obstetrics & Gynecology · 30d
Cleared Apr 17, 2020
Opticross 35 15 MHz Peripheral Imaging Catheter
K200733 · ITX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Apr 17, 2020
SI-Restore Sacroiliac Joint Fixation System
K200868 · OUR
Biofusion Medical
Orthopedic · 16d
Cleared Apr 16, 2020
Philips Biosensor BX100
K192875 · DRG
Philips Medical Systems
Cardiovascular · 191d
Cleared Apr 16, 2020
Unicel DxH 800 Coulter Cellular Analysis System
K193124 · GKZ
Beckman Coulter
Hematology · 156d
Cleared Apr 16, 2020
ARTIS Icono
K193326 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 136d
Cleared Apr 16, 2020
SIGMA High Performance (HP) Partial Knee System
K193549 · HRY
Depuy Ireland UC
Orthopedic · 118d
Cleared Apr 16, 2020
DD Contrast
K193588 · EIH
Dental Direkt GmbH
Dental · 115d
Cleared Apr 16, 2020
Traxcess 14 SELECT Guidewire
K200547 · MOF
MicroVention, Inc.
Neurology · 44d
Cleared Apr 16, 2020
EON Portable RO Water Purification System
K200670 · FIP
Mar Cor Purification, Inc.
Gastroenterology & Urology · 34d
Cleared Apr 16, 2020
HydroCision SpineJet System
K200729 · HRX
Hydrocision, Inc.
Orthopedic · 27d
Cleared Apr 16, 2020
Caption Guidance
K200755 · QJU
Caption Health
Radiology · 24d
Cleared Apr 15, 2020
7 mm Extended Length Endoscope
K191930 · GCJ
Maquet Cardiovascular, LLC
General & Plastic Surgery · 271d
Cleared Apr 15, 2020
G-EYE System
K192588 · FDF
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 209d
Cleared Apr 15, 2020
Serranator PTA Serration Balloon Catheter
K193181 · PNO
Cagent Vascular, LLC
Cardiovascular · 149d
Cleared Apr 15, 2020
Comprehensive® Reverse Shoulder
K193373 · PHX
Biomet, Inc.
Orthopedic · 132d
Cleared Apr 15, 2020
Monarch Platform
K193534 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 117d
Cleared Apr 15, 2020
Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical...
K193561 · FRG
Weihai Xingtai Packaging Products...
General Hospital · 114d
Cleared Apr 15, 2020
3MTM AttestTM Mini Auto-reader 490M
K200092 · FRC
3M
General Hospital · 90d
Cleared Apr 15, 2020
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with...
K200181 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 82d