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
18073–18096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2021
Ti3Z Cervical Interbody System
K202398 · ODP
Zavation Medical Products, LLC
Orthopedic · 161d
Cleared Jan 29, 2021
Prase-AP Anterior Cervical Plate System
K202878 · KWQ
Gbs Commonwealth Co., Ltd.
Orthopedic · 123d
Cleared Jan 29, 2021
Ventway Sparrow
K202970 · CBK
Inovytech Medical Solutions , Ltd.
Anesthesiology · 121d
Cleared Jan 29, 2021
cobas BKV
K203220 · QLX
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Jan 29, 2021
XYPAN Expandable Lumbar Cage System
K203531 · MAX
Aegis Spine, Inc.
Orthopedic · 58d
Cleared Jan 28, 2021
Michler-Kapp Cardiovascular Vent Catheter
K200289 · DWF
Kapp Surgical Instrument, Inc.
Cardiovascular · 358d
Cleared Jan 28, 2021
HipXpert 3D Display and Anchoring Application
K200384 · OSF
Surgical Planning Associates, Inc.
Orthopedic · 345d
Cleared Jan 28, 2021
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial...
K201016 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 286d
Cleared Jan 28, 2021
GenesisZr UHT700 Zirconia
K201608 · EIH
United Dental Resources Corporation
Dental · 227d
Cleared Jan 28, 2021
Standard Sterilizable Tray
K202524 · KCT
Implant Direct Sybron Manufacturing, LLC
General Hospital · 149d
Cleared Jan 28, 2021
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
K202754 · BTY
Eresearchtechnology GmbH
Anesthesiology · 129d
Cleared Jan 28, 2021
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
K202892 · MWI
Edan Instruments, Inc.
Cardiovascular · 122d
Cleared Jan 28, 2021
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K203223 · NZA
Steris
General Hospital · 87d
Cleared Jan 28, 2021
Biomet Microfixation RibFix Advantage System
K203474 · HRS
Biomet Micofixation
Orthopedic · 64d
Cleared Jan 28, 2021
Vitality® Spinal Fixation System
K203507 · NKB
Zimmer Biomet Spine, Inc.
Orthopedic · 59d
Cleared Jan 28, 2021
BOSS 8F Balloon Guide Catheter
K203840 · QJP
Marblehead Medical, LLC
Neurology · 28d
Cleared Jan 27, 2021
Wrist Electronic Sphygmomanometer
K193386 · DXN
Shenzhen Changkun Technology Co., Ltd.
Cardiovascular · 418d
Cleared Jan 27, 2021
Arm Electronic Sphygmomanometer
K193387 · DXN
Shenzhen Changkun Technology Co., Ltd.
Cardiovascular · 418d
Cleared Jan 27, 2021
Vivo 45 LS
K193586 · NOU
Breas Medical AB
Anesthesiology · 401d
Cleared Jan 27, 2021
EVOS Large Fragment Plating System
K203405 · HRS
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Jan 26, 2021
Altus Spine HA Pedicle Screw System
K200922 · NKB
Altus Partners, LLC
Orthopedic · 295d
Cleared Jan 26, 2021
Airway Mobilescope
K201300 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 256d
Cleared Jan 26, 2021
BTL-899ST
K202199 · GEI
Btl
General & Plastic Surgery · 174d
Cleared Jan 26, 2021
Blood Pressure Monitor
K202934 · DXN
Bioland Technology, Ltd.
Cardiovascular · 119d