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
7417–7440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2024
ALGO Pro Newborn Hearing Screener (ALGO Pro)
K233649 · GWJ
Natus Medical Incorporated Dba...
Ear, Nose, Throat · 115d
Cleared Mar 08, 2024
SleepStageML
K233438 · OLZ
Beacon Biosignals, Inc.
Neurology · 147d
Cleared Mar 08, 2024
RESCAN 700
K233421 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 150d
Cleared Mar 08, 2024
DOMINION Expandable Corpectomy System
K233359 · MQP
Astura Medical
Orthopedic · 161d
Cleared Mar 08, 2024
OSSIOfiber® Threaded Trimmable Fixation Nails
K233198 · HWC
OSSIO , Ltd.
Orthopedic · 162d
Cleared Mar 08, 2024
Nest VT Vitrification Device
K233177 · MQK
Cook Incorporated
Obstetrics & Gynecology · 162d
Cleared Mar 08, 2024
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
K233038 · MWI
Edan Instruments, Inc.
Cardiovascular · 165d
Cleared Mar 08, 2024
Articulator Injection Needle (00711807), Articulator Injection Needle...
K232826 · FBK
Steris
Gastroenterology & Urology · 177d
Cleared Mar 08, 2024
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
K231904 · DJG
Co-Innovation Biotech Co., Ltd.
Toxicology · 254d
Cleared Mar 08, 2024
Ultrasonic Gastrovideoscope
K231813 · ODG
Sonoscape Medical Corp.
Gastroenterology & Urology · 261d
Cleared Mar 08, 2024
HP-OCT (HP-OCT)
K231760 · HJO
Cylite Pty. , Ltd.
Ophthalmic · 266d
Cleared Mar 08, 2024
STERiJECT Low Dead Space, STERiJECT The Invisible Needle
K231734 · QNS
Tsk Laboratory International Japan KK
General Hospital · 268d
Cleared Mar 08, 2024
Esperance Distal Access Catheter
K231056 · QJP
Wallaby Medical
Neurology · 330d
Cleared Mar 08, 2024
Neo ADVISE software
K230195 · OLO
Comerge AG
Orthopedic · 408d
Cleared Mar 07, 2024
Synthetic Bone Putty
K240458 · MQV
Ventris Medical
Orthopedic · 20d
Cleared Mar 07, 2024
ICONIX All-Suture Anchor
K240407 · MBI
Stryker Endoscopy
Orthopedic · 27d
Cleared Mar 07, 2024
0909FCC, 0909FCC-HS
K240371 · MQB
Rayence Co., Ltd.
Radiology · 29d
Cleared Mar 07, 2024
Voluson Signature 20, Voluson Signature 18
K233692 · IYN
GE Medical Systems Ultrasound and...
Radiology · 111d
Cleared Mar 07, 2024
Safety Sliding Blood Collection Set
K232781 · JKA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 178d
Cleared Mar 07, 2024
D·Kutting™ PTA Scoring Balloon Dilatation Catheter
K232207 · PNO
Dk Medical Technology Co., Ltd.
Cardiovascular · 225d
Cleared Mar 06, 2024
e-SDF
K240619 · PHR
Kids-E-Dental Llp
Dental · 1d
Cleared Mar 06, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes
K240352 · ODC
STERIS Corporation
Gastroenterology & Urology · 30d
Cleared Mar 06, 2024
FaStep Fentanyl Rapid Test Device (Urine)
K240351 · NGL
Assure Tech., LLC
Toxicology · 30d
Cleared Mar 06, 2024
Access Free T4
K240273 · CEC
Beckman Coulter, Inc.
Chemistry · 35d