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
10657–10680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2023
Essenz HLM
K221373 · DTQ
Livanova Deutschland, GmbH
Cardiovascular · 301d
Cleared Mar 09, 2023
AutoPulse NXT Resuscitation System
K221700 · DRM
Zoll Circulation, Inc.
Cardiovascular · 269d
Cleared Mar 09, 2023
AccuContour
K221706 · QKB
Manteia Technologies Co., Ltd.
Radiology · 269d
Cleared Mar 09, 2023
Wesper Lab
K221816 · MNR
Wesper, Inc.
Anesthesiology · 260d
Cleared Mar 09, 2023
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
K221919 · HRX
Hemodia Sas
Orthopedic · 251d
Cleared Mar 09, 2023
CEREGLIDE 71 Intermediate Catheter
K221930 · QJP
Cerenovus, Inc.
Neurology · 251d
Cleared Mar 09, 2023
CEREGLIDE 71 Intermediate Catheter
K221934 · NRY
Cerenovus, Inc.
Neurology · 251d
Cleared Mar 09, 2023
VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN...
K222430 · LON
Biomerieux Sa, Inc.
Microbiology · 210d
Cleared Mar 09, 2023
MultiStage Balloon Dilatation Catheter
K222663 · FGE
Dongguan TT Medical, Inc.
Gastroenterology & Urology · 188d
Cleared Mar 09, 2023
Powered Muscle Stimulator (Model name:MagGraver F200)
K222875 · NGX
Nanjing Vishee Medical Technology...
Physical Medicine · 168d
Cleared Mar 09, 2023
Vassallo GT 018 Hybrid
K223432 · DQX
Filmecc Co., Ltd.
Cardiovascular · 115d
Cleared Mar 09, 2023
Spectral Bone Marrow
K223514 · JAK
Ge Medical Systems, LLC
Radiology · 107d
Cleared Mar 09, 2023
LED Lip Perfector, model: ZC-05
K223642 · ILY
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 93d
Cleared Mar 09, 2023
Electric breast pump (model: M5)
K223693 · HGX
Shenzhen Lutejiacheng Technology Co.,...
Obstetrics & Gynecology · 90d
Cleared Mar 09, 2023
Huvex Interspinous Fusion System
K223790 · PEK
Dio Medical Corp.
Orthopedic · 80d
Cleared Mar 09, 2023
CPS Locator 3D Delivery Catheter
K230363 · DQY
CenterPoint Systems, LLC
Cardiovascular · 27d
Cleared Mar 08, 2023
extriCARE 1000 Negative Pressure Wound Therapy System
K213906 · OMP
Alleva Medical, Ltd.
General & Plastic Surgery · 449d
Cleared Mar 08, 2023
Pulse Oximeter
K220101 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 420d
Cleared Mar 08, 2023
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb...
K220613 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 370d
Cleared Mar 08, 2023
SINEFIX
K220966 · MBI
BAAT Medical Products B.V.
Orthopedic · 341d
Cleared Mar 08, 2023
PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
K221209 · FXX
Padm Medical, Inc.
General Hospital · 316d
Cleared Mar 08, 2023
Arthrex Virtual Implant Positioning (VIP) System
K222007 · QHE
Arthrex, Inc.
Orthopedic · 244d
Cleared Mar 08, 2023
ManaSport+
K222098 · IMI
Manamed, Inc.
Physical Medicine · 233d
Cleared Mar 08, 2023
Cryo-Thermo Compression Device (FGK002)
K222136 · IRP
Suzhou Microport Rehabtech (Group)...
Physical Medicine · 232d