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
10729–10752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2023
Medical Diode Laser (M2)
K230274 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Mar 31, 2023
Iris AirShuttle™
K230312 · IYE
Qfix
Radiology · 56d
Cleared Mar 31, 2023
Aspirex™ Thrombectomy System
K230356 · QEW
C.R. Bard, Inc.
Cardiovascular · 50d
Cleared Mar 31, 2023
1788 4K Camera System with Advanced Imaging Modality
K230605 · GCJ
Stryker
General & Plastic Surgery · 28d
Cleared Mar 30, 2023
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with...
K220088 · LZA
Professional Latex Sdn Bhd
General Hospital · 443d
Cleared Mar 30, 2023
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing...
K221320 · OBO
Nidek Co., Ltd.
Ophthalmic · 328d
Cleared Mar 30, 2023
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
K221324 · OVD
Camber Spine Technologies
Orthopedic · 328d
Cleared Mar 30, 2023
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
K221872 · MPA
Nova Eye Inc. (Business Name Nova Eye...
Ophthalmic · 275d
Cleared Mar 30, 2023
Comfort Marker 2.0
K222112 · QRN
Medical Precision BV
Radiology · 255d
Cleared Mar 30, 2023
Axiom PSR System
K223326 · OYK
Restor3d
Orthopedic · 150d
Cleared Mar 30, 2023
MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System,...
K223342 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 149d
Cleared Mar 30, 2023
BIASURGE Advanced Surgical Solution
K223377 · FRO
Rochal Technologies, LLC
General & Plastic Surgery · 146d
Cleared Mar 30, 2023
Emory Cardiac Toolbox 4.3
K223422 · KPS
Syntermed
Radiology · 136d
Cleared Mar 30, 2023
Medartis APTUS® Ulna Plates
K223853 · HRS
Medartis AG
Orthopedic · 97d
Cleared Mar 30, 2023
HOPKINS Telescopes
K223923 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 90d
Cleared Mar 30, 2023
ONLINE TDM Phenytoin - Free Phenytoin application
K230161 · MOJ
Roche Diagnostics
Chemistry · 69d
Cleared Mar 30, 2023
Cemented Tibia Baseplate no Taper with JRNY Lock
K230555 · JWH
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 30, 2023
ARDO Bellis
K230590 · HGX
Ardo Medical AG
Obstetrics & Gynecology · 27d
Cleared Mar 30, 2023
Maestro Microcatheter
K230636 · KRA
Merit Medical System, Inc.
Cardiovascular · 23d
Cleared Mar 29, 2023
EndoDrill® Model X
K212423 · FCG
Bibbinstruments AB
Gastroenterology & Urology · 602d
Cleared Mar 29, 2023
SiJoin®T3
K213815 · OUR
Vgi Medical, Inc.
Orthopedic · 477d
Cleared Mar 29, 2023
InterView XP
K221984 · LLZ
Mediso Medical Imaging Systems, Lttd.
Radiology · 266d
Cleared Mar 29, 2023
RayStation 12A
K222312 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 240d
Cleared Mar 29, 2023
KLS Martin Level One Rib Fixation System
K222397 · HRS
KLS-Martin L.P.
Orthopedic · 233d