FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
5353–5376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2024
CDM Insights
K240680 · QIH
Oxford Brain Diagnostics, Ltd.
Radiology · 270d
Cleared Dec 06, 2024
Rugged Oxygen Generator (ROG) (RO01-00001)
K240561 · CAW
Molecular Products , Ltd.
Anesthesiology · 281d
Cleared Dec 06, 2024
OsteoSinter® EVANS and COTTON wedges and related accessories
K240461 · PLF
Ames Medical Prosthetic Solutions,...
Orthopedic · 294d
Cleared Dec 05, 2024
MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone...
K243526 · MQV
Orthocon, Inc.
Orthopedic · 21d
Cleared Dec 05, 2024
BIOFIRE FILMARRAY Tropical Fever Panel
K243463 · QMV
Biofire Diagnostics, LLC (Biomerieux)
Microbiology · 27d
Cleared Dec 05, 2024
Rapid Surgical Plan (RSP-SW-001)
K243447 · LLZ
Navbit Pty, Ltd.
Radiology · 28d
Cleared Dec 05, 2024
BIOCERAM AZUL® HEAD
K243444 · LZO
Kyocera Corporation
Orthopedic · 29d
Cleared Dec 05, 2024
Magnetic Localization Patch Kit (AFR-00021)
K243435 · DQK
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 05, 2024
Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
K242740 · EIH
Liaoning Rachcera Material Technology...
Dental · 85d
Cleared Dec 05, 2024
LW Pre-milled Abutment
K242703 · NHA
Ossvis Co., Ltd.
Dental · 87d
Cleared Dec 05, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242653 · JWY
Thermo Fisher Scientific
Microbiology · 92d
Cleared Dec 05, 2024
iTOF®
K242525 · KOI
Nerbio Medical Software Platforms, Inc.
Anesthesiology · 101d
Cleared Dec 05, 2024
OSTEOPAL® V
K241674 · LOD
Heraeus Medical GmbH
Orthopedic · 177d
Cleared Dec 05, 2024
TDM Plate and Screw System
K241128 · HRS
Tdm Co., Ltd.
Orthopedic · 225d
Cleared Dec 04, 2024
Chemical Indicator for enspire CLCSPS (LCC015)
K243475 · JOJ
STERIS Corporation
General Hospital · 26d
Cleared Dec 04, 2024
RelieVRx
K243417 · QRA
Appliedvr
Physical Medicine · 30d
Cleared Dec 04, 2024
Ion 3D
K243265 · MRW
SurGenTec, LLC
Orthopedic · 50d
Cleared Dec 04, 2024
SSPC NXT Delivery Catheter
K243180 · DQY
CenterPoint Systems, LLC
Cardiovascular · 65d
Cleared Dec 04, 2024
Triathlon Knee System
K242831 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 76d
Cleared Dec 04, 2024
Neodent Implant System
K242686 · NHA
Jjgc Ind?stria E Com?rcia DE...
Dental · 89d
Cleared Dec 04, 2024
Atellica® CH Creatinine_3 (Crea3)
K242685 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 89d
Cleared Dec 04, 2024
CapsoCam Plus (SV-3) Capsule Endoscopy System
K242643 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 92d
Cleared Dec 04, 2024
Nanox.ARC
K242395 · IZF
Nano-X Imaging , Ltd.
Radiology · 113d
Cleared Dec 04, 2024
Locking Screw,CoCrMo
K242348 · HWC
Double Medical Technology, Inc.
Orthopedic · 118d