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
10681–10704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 05, 2023
FAQ 101
K222012 · PAY
Foreo, Inc.
General & Plastic Surgery · 271d
Cleared Apr 05, 2023
Intermittent nelaton catheter for single use
K222677 · EZD
Hangzhou Jimushi Meditech Co., Ltd.
Gastroenterology & Urology · 211d
Cleared Apr 05, 2023
Optimos™ Cystotome
K223256 · KNS
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 166d
Cleared Apr 05, 2023
Antimicrobial Silicone PHMB Foam Wound Dressing
K223310 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 159d
Cleared Apr 05, 2023
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor,...
K223630 · MXD
Medtronic, Inc.
Cardiovascular · 121d
Cleared Apr 05, 2023
Da Vinci SP Surgical System (SP1098)
K230033 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 90d
Cleared Apr 05, 2023
BioSci™ Disposable Virus Sampling Tubes
K230035 · JSM
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 90d
Cleared Apr 05, 2023
Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
K230107 · OHT
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 82d
Cleared Apr 05, 2023
CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
K230336 · OAP
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 57d
Cleared Apr 05, 2023
T-FIX™ 3DSI Joint Fusion System
K230689 · OUR
Cutting Edge Spine, LLC
Orthopedic · 23d
Cleared Apr 04, 2023
Reprocessed NRG Transseptal Needle
K213584 · QLZ
Innovative Health, LLC
Cardiovascular · 508d
Cleared Apr 04, 2023
BRM Digitalis Spacer
K220142 · KYJ
Brm Extremities Srl
Orthopedic · 441d
Cleared Apr 04, 2023
NeuroStar Advanced Therapy System (Version 3.7)
K230029 · OBP
Neuronetics
Neurology · 90d