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
7585–7608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2024
AGILON® XO Shoulder Replacement System
K231657 · KWT
Implantcast GmbH
Orthopedic · 254d
Cleared Feb 16, 2024
Oral Matrix
K231513 · NPL
Beijing Biosis Healing Biolog Ical...
Dental · 267d
Cleared Feb 16, 2024
SnapHammer Hammertoe Correction System
K231453 · HWC
Nvision Biomedical Technologies, Inc.
Orthopedic · 274d
Cleared Feb 16, 2024
Medline Luer Lock Syringes
K230235 · FMF
Medline Industries, LP
General Hospital · 385d
Cleared Feb 15, 2024
InVision™ 1.5 Surgical Theatre
K240157 · LNH
Deerfield Imaging, Inc.
Radiology · 27d
Cleared Feb 15, 2024
Medical Monitor (21HQ613D)
K240130 · PGY
Lg Electronics.Inc
Radiology · 29d
Cleared Feb 15, 2024
SONIK MONARK 100
K234036 · LXM
Neuro Spinal Innovation, Inc.
Physical Medicine · 56d
Cleared Feb 15, 2024
COPAL® exchange G hip spacer
K234028 · KWL
Heraeus Medical GmbH
Orthopedic · 57d
Cleared Feb 15, 2024
Contour Shoulder
K233656 · MOS
Quality Electrodynamics
Radiology · 93d
Cleared Feb 15, 2024
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere...
K233483 · MCW
Cardio Flow Inc.,
Cardiovascular · 111d
Cleared Feb 15, 2024
EpiMonitor
K232915 · POS
Empatica S.R.L.
Neurology · 149d
Cleared Feb 15, 2024
VedDilator ^TM (3-Stage Balloon Dilation Catheter)
K232245 · FGE
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 202d
Cleared Feb 15, 2024
MS55 Plus Digital Color Doppler Ultrasound System (MS55)
K231659 · IYN
Medisono
Radiology · 253d
Cleared Feb 15, 2024
EMPHASYS™ Dual Mobility System
K231522 · LPH
Depuy Ireland UC
Orthopedic · 265d
Cleared Feb 15, 2024
Bronchoscope System
K231107 · EOQ
Hunan Endoso Life Technology Co., Ltd.
Ear, Nose, Throat · 302d
Cleared Feb 15, 2024
PBC Separator with Selux AST System
K223493 · QZX
Selux Diagnostics, Inc.
Microbiology · 451d
Cleared Feb 15, 2024
Breathing circuit bacterial/viral filter
K222917 · CAH
Shaoxing Haitech Medical Products...
General Hospital · 507d
Cleared Feb 14, 2024
airVata™
K240427 · LRK
Gelb Practice Solutions, Inc.
Dental · 1d
Cleared Feb 14, 2024
Radiography 7000 M
K233678 · IZL
Philips Medical Systems Dmc GmbH
Radiology · 90d
Cleared Feb 14, 2024
Azure
K231514 · GEX
Daeshin Enterprise Co., Ltd.
General & Plastic Surgery · 265d
Cleared Feb 13, 2024
Easi-Vue® embolic microspheres System
K234123 · KRD
Abk Biomedical, Inc.
Cardiovascular · 47d
Cleared Feb 13, 2024
M.U.S.T. Pedicle Screw System - Extension
K234048 · NKB
Medacta International S.A.
Orthopedic · 54d
Cleared Feb 13, 2024
EPi-Ease Epicardial Access Device (EAS)
K233959 · DYB
AtriCure, Inc.
Cardiovascular · 60d
Cleared Feb 13, 2024
Chemi-SiL (HB, MB, LB, LBS)
K233954 · ELW
B&E Korea Co., Ltd.
Dental · 60d