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
3097–3120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 2025
GECHO
K250120 · LLZ
Narnar, LLC
Radiology · 179d
Cleared Jul 14, 2025
F&P Optiflow Air/Oxygen Flow Source
K243917 · BZR
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 206d
Cleared Jul 13, 2025
Welch Allyn Connex® 360 (Multiple)
K243598
Welch Allyn, Inc.
Cardiovascular · 234d
Cleared Jul 12, 2025
NightWatch+ US
K243199 · POS
Livassured BV
Neurology · 284d
Cleared Jul 11, 2025
Achieva
K251808 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared Jul 11, 2025
Geistlich Bio-Oss®
K251786 · NPM
Geistlich Pharma AG
Dental · 30d
Cleared Jul 11, 2025
AEON™ Endoscopic Powered Stapler
K251482 · GAG
Lexington Medical, Inc.
General & Plastic Surgery · 58d
Cleared Jul 11, 2025
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
K251472 · HBW
Inion OY
Neurology · 59d
Cleared Jul 11, 2025
ResiCem EX
K251470 · EMA
Shofu Dental Corporation
Dental · 59d
Cleared Jul 11, 2025
Resolve Anterior Cervical Plate System
K251436 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 64d
Cleared Jul 11, 2025
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and...
K251352 · BSZ
Codonics.Incorporated
Anesthesiology · 72d
Cleared Jul 11, 2025
BD Cathena™ Safety IV Catheter
K251155 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 88d
Cleared Jul 11, 2025
AviClear Laser System
K251149 · GEX
Cutera, Inc.
General & Plastic Surgery · 88d
Cleared Jul 11, 2025
RipCord
K251134 · HTN
TriMed, Inc.
Orthopedic · 91d
Cleared Jul 11, 2025
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP,...
K250942 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 105d
Cleared Jul 11, 2025
Disposable Trocars
K250820 · GCJ
Sinolinks Medical Innovation, Inc.
General & Plastic Surgery · 115d
Cleared Jul 11, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional...
K250772 · NLH
Surgical Instrument Service and...
Cardiovascular · 120d
Cleared Jul 11, 2025
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S)
K250762 · ITX
Olympus Medical Systems Corporation
Radiology · 120d
Cleared Jul 11, 2025
KALA Therapy Wand (Model: KALA-03)
K250761 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 120d
Cleared Jul 11, 2025
FreeStyle Comfort (AS200 / FreeStyle Comfort)
K250671 · CAW
Caire, Inc.
Anesthesiology · 128d
Cleared Jul 11, 2025
Ceragem Automatic Thermal Massager (CGM MB-2401)
K250266 · JFB
Ceragem Co., Ltd.
Physical Medicine · 162d
Cleared Jul 11, 2025
Choice 2 DC
K250156 · EMA
Bisco, Inc.
Dental · 171d
Cleared Jul 11, 2025
Natural rubber latex male condom
K250034 · HIS
Shaoguan Regenex Pharmaceuticals Co.,...
Obstetrics & Gynecology · 185d
Cleared Jul 11, 2025
TurbAlign
K243655 · LYA
Spirair, Inc.
Ear, Nose, Throat · 227d