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
8017–8040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2023
Angled Abutment
K232560 · NHA
Arum Dentistry Co., Ltd.
Dental · 118d
Cleared Dec 19, 2023
JETi™Hydrodynamic Thrombectomy System
K232458 · QEZ
Abbott Medical
Cardiovascular · 126d
Cleared Dec 19, 2023
IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850...
K231671 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 194d
Cleared Dec 19, 2023
CORAIL Cemented Femoral Stem
K231526 · KWY
Depuy Ireland UC
Orthopedic · 207d
Cleared Dec 19, 2023
PMT Facet Fixation System, Lumbar (PMT FFS-LX)
K230840 · MRW
Providence Medical Technology, Inc.
Orthopedic · 267d
Cleared Dec 19, 2023
TD-7301 Peak Flow meter
K222810 · BZH
Gostar Co., Ltd.
Anesthesiology · 459d
Cleared Dec 19, 2023
Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode,...
K221199 · GXY
Green Island International Tcm Group...
Neurology · 602d
Cleared Dec 18, 2023
ClotTriever Sheath
K233815 · QEW
Inari Medical, Inc.
Cardiovascular · 18d
Cleared Dec 18, 2023
Ion Endoluminal System (IF1000)
K232984 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 87d
Cleared Dec 18, 2023
SiOxD Wound Matrix
K232847 · QSZ
Sioxmed, LLC
General & Plastic Surgery · 95d
Cleared Dec 18, 2023
CC-Clip® Implant System
K232780 · HTN
Cc-Instruments, Inc.
Orthopedic · 98d
Cleared Dec 18, 2023
iQ-solutions
K231929 · QIH
Sydney Neuroimaging Analysis Centre...
Radiology · 171d
Cleared Dec 18, 2023
MAGNETOM Cima.X
K231587 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 201d
Cleared Dec 18, 2023
S-Plant Dental Implant System
K231429 · DZE
Idis Co., Ltd.
Dental · 215d
Cleared Dec 18, 2023
CuratOR EX3242-FD
K231066 · GCJ
Eizo Corporation
General & Plastic Surgery · 248d
Cleared Dec 18, 2023
Access hsTnI
K222881 · MMI
Beckman Coulter, Inc.
Chemistry · 452d
Cleared Dec 18, 2023
AMT G-Tube Balloon Gastrostomy Feeding Device
K222846 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 453d
Cleared Dec 17, 2023
FlexCath Cross Transseptal Solution
K233691 · DYB
Acutus Medical, Inc.
Cardiovascular · 31d
Cleared Dec 16, 2023
Air Compression Recovery System
K233536 · IRP
Shenzhen Dongjilian Medical Tech Co.,...
Physical Medicine · 43d
Cleared Dec 15, 2023
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
K233682 · OVY
STERIS Corporation
General Hospital · 29d
Cleared Dec 15, 2023
ConFirm 20 Minute Incubator
K233681 · FRC
STERIS Corporation
General Hospital · 29d
Cleared Dec 15, 2023
Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000),...
K233668 · MCW
Eximo Medical, Ltd.
Cardiovascular · 30d
Cleared Dec 15, 2023
MagnetOs Easypack Putty
K233607 · MQV
Kuros Biosciences B.V
Orthopedic · 36d
Cleared Dec 15, 2023
FLUOBEAM® LX Imaging System (FB-LX)
K233564 · QDG
Fluoptics Sas (A Getinge Group Company)
General & Plastic Surgery · 39d