FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
10393–10416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 2023
PRO Plating System, Stryker Trauma Pelvic Set (Matta)
K223772 · HRS
Stryker GmbH
Orthopedic · 112d
Cleared Apr 07, 2023
Dental CT Scanner AXR
K223816 · OAS
Alliage S/A Industrias Medico...
Radiology · 108d
Cleared Apr 07, 2023
Mazor X System (Mazor X Stealth Edition)
K230064 · OLO
Mazor Robotics , Ltd.
Orthopedic · 88d
Cleared Apr 07, 2023
Memo 3D Semirigid Annuloplasty Ring
K230318 · KRH
Corcym S.r.l.
Cardiovascular · 60d
Cleared Apr 07, 2023
Limbus Contour
K230575 · LLZ
Limbus Ai, Inc.
Radiology · 37d
Cleared Apr 07, 2023
SKOUT® system
K230658 · QNP
Iterative Scopes, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 06, 2023
RayFlow
K222023 · DQY
Hexacath
Cardiovascular · 269d
Cleared Apr 06, 2023
F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
K222197 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 258d
Cleared Apr 06, 2023
AI-Rad Companion (Cardiovascular)
K222360 · JAK
Siemens Medical Solutions U.S.A.
Radiology · 245d
Cleared Apr 06, 2023
Disposable Insulin Pen Needle
K222739 · FMI
Hantech Medical Device Co., Ltd.
General Hospital · 209d
Cleared Apr 06, 2023
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700...
K223458 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 141d
Cleared Apr 06, 2023
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19,...
K223531 · MHX
GE Healthcare Finland Oy
Cardiovascular · 134d
Cleared Apr 06, 2023
Contour ProtégéAI
K223774 · QKB
Mim Software, Inc.
Radiology · 111d
Cleared Apr 06, 2023
S.I.N. Dental Implant System
K230069 · NHA
S.I.N. ? Sistema DE Implante Nacional...
Dental · 86d
Cleared Apr 06, 2023
IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105,...
K230097 · OHT
Shenzhen Bsx Technology Electronics...
General & Plastic Surgery · 83d
Cleared Apr 06, 2023
EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert
K230169 · JWH
Encore Medical, L.P Dba Enovis
Orthopedic · 76d
Cleared Apr 06, 2023
QUANTUM Patient Specific Instrumentation (PSI) System
K230313 · HSN
In2bones Sas
Orthopedic · 59d
Cleared Apr 06, 2023
ACRIFIX
K230341 · EBI
Deltamed GmbH
Dental · 57d
Cleared Apr 06, 2023
Affinity Fusion™ Oxygenator System
K230640 · DTZ
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 05, 2023
N2
K211556 · EIA
Megagen Implant Co., Ltd.
Dental · 686d
Cleared Apr 05, 2023
D·Kaptain PTA High Pressure Balloon Dilatation Catheter
K214009 · LIT
Dk Medical Technology Co., Ltd.
Cardiovascular · 516d
Cleared Apr 05, 2023
CO2 Mainstream Sensor
K221118 · CCK
Draegerwerk AG & CO Kgaa
Anesthesiology · 352d
Cleared Apr 05, 2023
MicroScan Prompt Inoculation System-D
K221493 · LIE
Beckman Coulter, Inc.
Microbiology · 317d
Cleared Apr 05, 2023
Nightwear Aligners
K221537 · NXC
Smylio, Inc.
Dental · 313d