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
8473–8496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 30, 2023
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic...
K232145 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 103d
Cleared Oct 30, 2023
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
K231965 · IYN
GE Medical Systems Ultrasound and...
Radiology · 119d
Cleared Oct 30, 2023
AOT & T-L Abutment
K231874 · NHA
Truabutment, Inc.
Dental · 126d
Cleared Oct 30, 2023
ClariVy™ Cervical IBF System
K231836 · ODP
Vy Spine, LLC
Orthopedic · 130d
Cleared Oct 30, 2023
Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate...
K231378 · PLP
Insightec , Ltd.
Gastroenterology & Urology · 171d
Cleared Oct 30, 2023
Renova Spine Balloon Catheter
K231340 · NDN
Biopsybell S.R.L.
Orthopedic · 174d
Cleared Oct 30, 2023
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
K231222 · OBO
Topcon Corporation
Ophthalmic · 185d
Cleared Oct 30, 2023
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
K231029 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 202d
Cleared Oct 30, 2023
NuEra Tight RF Model OptiStream
K230755 · PBX
Bios S.R.L.
General & Plastic Surgery · 227d
Cleared Oct 30, 2023
Empatica Health Monitoring Platform
K230457 · MWI
Empatica S.R.L.
Cardiovascular · 251d
Cleared Oct 29, 2023
NextAR™ TSA Platform
K232280 · SBF
Medacta International S.A.
Orthopedic · 90d