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
22273–22296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2019
Arrow Epidural Needle KZ-05500-007(Luer)
K190026 · BSP
Teleflex Medical
Anesthesiology · 226d
Cleared Aug 21, 2019
VSP Orthopedics System
K190044 · PBF
3D Systems, Inc.
Orthopedic · 224d
Cleared Aug 21, 2019
RAS 12 Rack, RAS 12 Long Rack
K190081 · NVE
STERIS Corporation
General Hospital · 217d
Cleared Aug 21, 2019
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip...
K191413 · PZX
AtriCure, Inc.
Cardiovascular · 85d
Cleared Aug 21, 2019
ScanX Touch/ScanX Duo Touch
K191623 · MUH
Air Techniques, Inc.
Radiology · 64d
Cleared Aug 21, 2019
GlideScope BFlex 5.8 Single-Use Bronchoscope
K191948 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 30d
Cleared Aug 20, 2019
ARCO FP
K182086 · OWB
A.T.S. Applicazione Tecnologie...
Radiology · 383d
Cleared Aug 20, 2019
Exactech Equinoxe Humeral Augmented Trays
K191561 · PHX
Exactech, Inc.
Orthopedic · 68d
Cleared Aug 20, 2019
iNSitu Total Hip System
K191936 · LPH
Thecken Companies, LLC
Orthopedic · 32d
Cleared Aug 19, 2019
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical...
K183356 · FRG
Weihai Xingtai Packaging Products...
General Hospital · 258d
Cleared Aug 19, 2019
Blood Pressure Monitor
K190207 · DXN
Shenzhen Viatom Technology Co., Ltd.
Cardiovascular · 196d
Cleared Aug 19, 2019
Zavation eZspand Interbody System
K191339 · MAX
Zavation Medical Products, LLC
Orthopedic · 91d
Cleared Aug 19, 2019
CrossRoads Screw System
K191342 · HWC
Crossroads Extemity Systems, LLC
Orthopedic · 91d
Cleared Aug 19, 2019
Optilite IgA Kit
K191985 · CFN
The Binding Site Group , Ltd.
Immunology · 25d
Cleared Aug 16, 2019
Combined Aerobika OPEP and VersaPAP device
K183108 · BWF
Trudell Medical International
Anesthesiology · 281d
Cleared Aug 16, 2019
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
K183536 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 240d
Cleared Aug 16, 2019
TriMAX Implant System
K190722 · JDR
Crossroads Extemity Systems, LLC
Orthopedic · 149d
Cleared Aug 16, 2019
EQ Balance
K190735 · LXV
Upright Science, Inc.
Ear, Nose, Throat · 148d
Cleared Aug 16, 2019
Vyntus BODY
K190853 · BZC
Vyaire Medical, Inc.
Anesthesiology · 136d
Cleared Aug 16, 2019
GIM-STIM OTC TENS/EMS System
K190988 · NUH
Gemore Technology Co, Ltd.
Neurology · 123d
Cleared Aug 16, 2019
Piezon Built-in Kit, Piezon Built-in Kit LED
K191079 · ELC
E.M.S Electro Medical Systems S.A
Dental · 115d
Cleared Aug 16, 2019
980nm Diode Laser Therapy Device
K191349 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 88d
Cleared Aug 16, 2019
PowerDR
K191504 · JAA
Radiology Information Systems, Inc.
Radiology · 71d
Cleared Aug 16, 2019
Tria Soft Ureteral Stent
K191609 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 60d