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
9217–9240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2023
1.5T HD T/R Knee Array (10-F34127)
K231085 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 123d
Cleared Aug 18, 2023
Unicare (K-UNICARE-USA)
K231053 · NUH
Tenscare, Ltd.
Neurology · 127d
Cleared Aug 18, 2023
12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the...
K231026 · PGY
Shenzhen Beacon Display Technology...
Radiology · 129d
Cleared Aug 18, 2023
Smart Wedge algorithm
K230579 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 169d
Cleared Aug 18, 2023
Daye Tampon
K223883 · HEB
Annes Daye, Ltd.
Obstetrics & Gynecology · 234d
Cleared Aug 18, 2023
IDS ACTH II
K223867 · CKG
Immunodiagnostic Systems Limited
Chemistry · 238d
Cleared Aug 18, 2023
Onera Sleep Test System (Onera STS)
K223573 · MNR
Onera B.V.
Neurology · 261d
Cleared Aug 18, 2023
Dreem 3S
K223539 · OLZ
Beacon Biosignals, Inc.
Neurology · 268d
Cleared Aug 18, 2023
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite...
K223526 · FRO
Smith & Nephew Medical Limited
General & Plastic Surgery · 268d
Cleared Aug 18, 2023
Sleepiz One+
K223163 · DRT
Sleepiz AG
Cardiovascular · 315d
Cleared Aug 18, 2023
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim,...
K222993 · KGO
Sentienx Sdn Bhd
General Hospital · 324d
Cleared Aug 18, 2023
Eco Abutment, Multiunit Abutment
K220253 · NHA
Dio Corporation
Dental · 564d
Cleared Aug 17, 2023
Xpert Xpress CoV-2/Flu/RSV plus
K231481 · QOF
Cepheid
Microbiology · 86d
Cleared Aug 17, 2023
EXTRON 5
K230871 · OWB
DRTECH Corporation
Radiology · 140d
Cleared Aug 17, 2023
Tandry Locking Plate System
K230690 · HRS
Microware Precision Co., Ltd.
Orthopedic · 157d
Cleared Aug 17, 2023
Aer-O-Scope Colonoscope System
K230588 · FDF
Gi View , Ltd.
Gastroenterology & Urology · 168d
Cleared Aug 17, 2023
Cadwell Guardian
K230415 · GWF
Cadwell Industries, Inc.
Neurology · 182d
Cleared Aug 17, 2023
InterCollagen® Guide
K223912 · NPL
Sigmagraft, Inc.
Dental · 231d
Cleared Aug 17, 2023
Integrity Implant
K223538 · OWX
Anika Therapeutics, Inc.
Orthopedic · 267d
Cleared Aug 17, 2023
Spirair Nasal Septal Strap
K223167 · NHB
Spirair, Inc.
Ear, Nose, Throat · 314d
Cleared Aug 17, 2023
Feeding Tube
K222773 · PIF
Anhui Tiankang Medical Technology...
Gastroenterology & Urology · 337d
Cleared Aug 17, 2023
Oral/Enteral Syringe with ENFit connector
K222772 · PNR
Anhui Tiankang Medical Technology...
Gastroenterology & Urology · 337d
Cleared Aug 16, 2023
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw)
K232141 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Aug 16, 2023
EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral...
K232126 · GAG
Covidien
General & Plastic Surgery · 30d