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
8737–8760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2023
Bard 3DMax Mesh
K233402 · FTL
Davol Inc., Subsidiary of C. R. Bard,...
General & Plastic Surgery · 28d
Cleared Nov 01, 2023
Inzii Ripstop Redeployable Retrieval System
K232880 · GCJ
Applied Medical Resources Corporation
General & Plastic Surgery · 44d
Cleared Nov 01, 2023
Aventus Thrombectomy System
K232730 · QEW
Inquis Medical
Cardiovascular · 55d
Cleared Nov 01, 2023
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
K231414 · DTZ
Chalice Medical , Ltd.
Cardiovascular · 169d
Cleared Nov 01, 2023
OptiMesh Multiplanar Expandable Interbody Fusion System
K230927 · OQB
Spineology, Inc.
Orthopedic · 212d
Cleared Oct 31, 2023
LINQ II™ Insertable Cardiac Monitor (LNQ22)
K233320 · MXD
Medtronic, Inc.
Cardiovascular · 32d
Cleared Oct 31, 2023
FlexCath Contour™ Steerable Sheath
K232321 · DRA
Medtronic, Inc.
Cardiovascular · 89d
Cleared Oct 31, 2023
VICTORY™ Lumbar Plate System
K232318 · KWQ
Globus Medical, Inc.
Orthopedic · 89d
Cleared Oct 31, 2023
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or...
K232310 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 31, 2023
HemoSphere Alta Advanced Monitoring Platform
K232294 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 91d
Cleared Oct 31, 2023
Neodent Implant System - GM Zygomatic Implant System
K232099 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 110d
Cleared Oct 31, 2023
EVOLUTION® Cement Keel
K231947 · JWH
Microport Orthopedics, Inc.
Orthopedic · 123d
Cleared Oct 31, 2023
Electric Wheelchair (Robooter E40), Model name: BBR-E40-01
K231868 · ITI
Shanghai Bangbang Robotics Co., Ltd.
Physical Medicine · 127d
Cleared Oct 31, 2023
091 Balloon Guide Catheter
K231629 · DQY
Eosolutions, Corp.
Neurology · 148d
Cleared Oct 31, 2023
OCS Heart Leukocyte Depleting Filter
K231362 · DTM
TransMedics, Inc.
Cardiovascular · 173d
Cleared Oct 31, 2023
Ultravision2™ System Integrated Monopolar L-Hook (H/S)™
K231298 · PQM
Alesi Surgical, Ltd.
General Hospital · 180d
Cleared Oct 31, 2023
Finger Clip Pulse Oximeter
K231243 · DQA
Guangdong Genial Technology Co., Ltd.
Anesthesiology · 183d
Cleared Oct 31, 2023
Ultravision2™ System
K231238 · PQM
Alesi Surgical, Ltd.
General Hospital · 186d
Cleared Oct 31, 2023
VRNT
K230814 · QRA
Cognifisense, Inc.
Physical Medicine · 221d
Cleared Oct 31, 2023
Hudson RCI® TurboMist™ Nebulizer System
K230602 · CAF
Medline Industries, LP
Anesthesiology · 242d
Cleared Oct 31, 2023
Tornier Humeral Nail and Tornier Long Humeral Nail
K230352 · HSB
Tornier, Inc.
Orthopedic · 264d
Cleared Oct 31, 2023
Speedboat Flush SB1 Instrument
K230328 · KNS
Creo Medical, Ltd.
Gastroenterology & Urology · 267d
Cleared Oct 31, 2023
SAFIRA
K230083 · FRN
Medovate Limited
General Hospital · 293d
Cleared Oct 30, 2023
BriefCase-Triage
K232751 · QAS
Aidoc Medical , Ltd.
Radiology · 52d