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
11569–11592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2022
Vista BC Sealer
K221811 · KIF
Inter-Med, Inc.
Dental · 152d
Cleared Nov 21, 2022
Disposable Sterile Lancet
K222246 · QRL
Tianjin Rilifine Medical Device Co.,...
General & Plastic Surgery · 118d
Cleared Nov 21, 2022
Kowa SL-19
K222372 · HJO
Kowa Company , Ltd.
Ophthalmic · 108d
Cleared Nov 21, 2022
Flex-Thread™ Ulna Intramedullary Nail System
K222390 · HSB
Flower Orthopedics Corporation Dba...
Orthopedic · 105d
Cleared Nov 21, 2022
Disposable Blood Pressure Cuff
K222420 · DXQ
Wenzhou Xikang Medical Instruments...
Cardiovascular · 102d
Cleared Nov 21, 2022
Treace Medical Concepts (TMC) Implant Fixation System
K222645 · JDR
Treace Medical Concepts
Orthopedic · 81d
Cleared Nov 21, 2022
SM-V
K222951 · IZL
Sedecal., Sa.
Radiology · 55d
Cleared Nov 21, 2022
Pentax Medical Valve Set
K222980 · ODC
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 54d
Cleared Nov 21, 2022
SIS System (Version 5.6.0)
K223032 · QIH
Surgical Information Sciences, Inc.
Radiology · 53d
Cleared Nov 21, 2022
Miro3D Wound Matrix
K223257 · KGN
Reprise Biomedical
General & Plastic Surgery · 31d
Cleared Nov 20, 2022
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use...
K221165 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 212d
Cleared Nov 20, 2022
Empatica Health Monitoring Platform
K221282 · DQA
Empatica S.R.L.
Anesthesiology · 201d
Cleared Nov 18, 2022
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
K210623 · DFH
Sebia
Immunology · 626d
Cleared Nov 18, 2022
Konig Mogen Clamp
K212911 · HFX
Medline Industries, Inc.
Obstetrics & Gynecology · 431d
Cleared Nov 18, 2022
Auxilock GFS Mini, GFS II Large, and GFS Ultimate
K213018 · MBI
Auxein Medical Private Limited
Orthopedic · 424d
Cleared Nov 18, 2022
Polso Watch
K220351 · DQA
Chronisense Medical, Ltd.
Anesthesiology · 284d
Cleared Nov 18, 2022
COSY Cervicothoracic Occipital Rod-Screw System
K220658 · NKG
Signus Medizintechnik GmbH
Orthopedic · 256d
Cleared Nov 18, 2022
BriefCase
K221330 · QAS
Aidoc Medical , Ltd.
Radiology · 196d
Cleared Nov 18, 2022
FBCC Night Guard
K221369 · OBR
Fbcc, Inc.
Dental · 190d
Cleared Nov 18, 2022
Single-Use Flexible Cystoscope
K221580 · FAJ
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 170d
Cleared Nov 18, 2022
Single-Use Flexible Rhinolaryngoscope
K221581 · EOB
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 170d
Cleared Nov 18, 2022
SiOxD Wound Matrix
K222189 · QSZ
Sioxmed, LLC
General & Plastic Surgery · 119d
Cleared Nov 18, 2022
Calibrate LTX Interbody System
K222455 · MAX
Alphatec Spine, Inc.
Orthopedic · 95d
Cleared Nov 18, 2022
Hair Growth Device
K222477 · OAP
Dongguan Lescolton Medical Equipment...
General & Plastic Surgery · 94d