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
28945–28968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 2017
Tubing Pack
K171308 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 02, 2017
Palisade™ Pedicular Fixation System
K171438 · NKB
Spineology, Inc.
Orthopedic · 17d
Cleared Jun 01, 2017
Medcomp Vessel Dilator
K162389 · DRE
Medcomp ( Medical Components)
Cardiovascular · 279d
Cleared Jun 01, 2017
MATISSE Anterior Cervical Interbody Fusion Cage System
K162682 · ODP
Ctl Medical Corporation
Orthopedic · 248d
Cleared Jun 01, 2017
OARtrac System with Patient Specific Reusable Universal PSD Sensors
K162954 · NZT
Radiadyne, LLC
Radiology · 220d
Cleared Jun 01, 2017
Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule...
K163609 · NHV
Pall International Sarl
Gastroenterology & Urology · 161d
Cleared Jun 01, 2017
PowerGlide ST Midline Catheter
K170158 · PND
C.R. Bard, Inc.
General Hospital · 134d
Cleared Jun 01, 2017
Carbon Dioxide Reagent Set
K170200 · KHS
Teco Diagnostics, Inc.
Chemistry · 129d
Cleared Jun 01, 2017
System, Applicator, Radionuclide, Remote Controlled
K170203 · JAQ
Kobold, LLC
Radiology · 129d
Cleared Jun 01, 2017
Celesteion, PCA-9000A/3
K170490 · KPS
Toshibamedical Systems Corporation
Radiology · 104d
Cleared Jun 01, 2017
ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT...
K170652 · PRI
Fisher Diagnostics
Microbiology · 90d
Cleared Jun 01, 2017
Reinforced Flexible Collagen Nerve Cuff
K170656 · JXI
Collagen Matrix, Inc.
Neurology · 90d
Cleared Jun 01, 2017
ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder...
K170711 · PHX
Zimmer GmbH
Orthopedic · 85d
Cleared Jun 01, 2017
GTK Disposable Needle Guides
K170741 · ITX
Geotek Medikal Ltd Sti
Radiology · 83d
Cleared Jun 01, 2017
Biograph Horizon PET/CT
K170904 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Jun 01, 2017
syngo Dynamics Version VA30
K171053 · LLZ
Siemens Healthcare GmbH
Radiology · 52d
Cleared Jun 01, 2017
Xenocor Xenoscope Laparoscopic System
K171344 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 24d
Cleared May 31, 2017
Infusion Set for Single Use
K162601 · FPA
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 254d
Cleared May 31, 2017
SL 220
K162684 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 247d
Cleared May 31, 2017
Orthodontic Acrylic 2
K163482 · EBI
Lang Dental Manufacturing Co., Inc.
Dental · 170d
Cleared May 31, 2017
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
K170007 · HQD
Acuity Polymers, Inc.
Ophthalmic · 148d
Cleared May 31, 2017
OptiFix AT Absorbable Fixation System with Articulating Technology - 30...
K170278 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 121d
Cleared May 31, 2017
Empowr CR Knee Tibial Insert
K170573 · JWH
Encore Medical, L.P.
Orthopedic · 93d
Cleared May 31, 2017
Modified Alma Lasers Soprano XL Family of Multi-Application &...
K170626 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 90d