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
20281–20304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 15, 2020
Molekule Air Pro RX
K200500 · FRA
Molekule, Inc.
General Hospital · 47d
Cleared Apr 15, 2020
Tritanium® X TL Expandable Curved Posterior Lumbar Cage
K200613 · MAX
Stryker Corporation
Orthopedic · 37d
Cleared Apr 15, 2020
I-View Gold and Imagen Gold Dental Sensors
K200625 · MUH
Trident S.R.L
Radiology · 36d
Cleared Apr 15, 2020
ACUSON Sequoia Diagnostic Ultrasound System
K200707 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Apr 15, 2020
AS-10
K200887 · OWB
Canon, Inc.
Radiology · 13d
Cleared Apr 14, 2020
Solax Powered Wheelchair (Models: S7101, S7103)
K182400 · ITI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 588d
Cleared Apr 14, 2020
COMET Lumbar Interbody Fusion Cage
K191353 · MAX
Baui Biotech Co., Ltd.
Orthopedic · 329d
Cleared Apr 14, 2020
SILICONE Personal Lubricant
K191654 · NUC
Bath Concept Cosmetics (Dongguan)...
Obstetrics & Gynecology · 299d
Cleared Apr 14, 2020
Orthopedic Fixation Pin
K191803 · JDW
Tinavi (Anhui) Medical Technologies...
Orthopedic · 286d
Cleared Apr 14, 2020
UroLift System Procedure Kit Sterilization Tray
K192781 · KCT
Neotract, Inc.
General Hospital · 197d