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
11833–11856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2022
EndoNaut
K222070 · OWB
Therenva Sas
Radiology · 103d
Cleared Oct 25, 2022
Unistik® Pro
K222303 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 85d
Cleared Oct 25, 2022
Leltek Ultrasound Imaging System (Model: LU700 Series)
K222365 · IYN
Leltek, Inc.
Radiology · 82d
Cleared Oct 25, 2022
Rexious Spinal Fixation System
K222415 · NKB
Dio Medical Corporation
Orthopedic · 76d
Cleared Oct 25, 2022
3Dicom MD
K222470 · LLZ
Singular Health Pty, Ltd.
Radiology · 70d
Cleared Oct 25, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction...
K222968 · LNH
Canon Medical Systems Corporation
Radiology · 28d
Cleared Oct 24, 2022
KODEX – EPD™ System 1.5.0
K212493 · DQK
Philips Medical Systems Nederland,...
Cardiovascular · 441d
Cleared Oct 24, 2022
The GIRO Growth Modulation System
K220190 · OBT
Pega Medical, Inc.
Orthopedic · 273d
Cleared Oct 24, 2022
MectaLIF Anterior Extension
K221545 · OVD
Medacta International S.A.
Orthopedic · 150d
Cleared Oct 24, 2022
Neurosteer EEG Recorder
K221563 · OMC
Neurosteer, Inc.
Neurology · 146d
Cleared Oct 24, 2022
SafetiCET Safety Lancet
K221783 · FMK
Nsp Tech Pte, Ltd.
General & Plastic Surgery · 125d
Cleared Oct 24, 2022
Soft Palate Elevator
K222127 · LRK
The Tmj Clinic PC
Dental · 98d
Cleared Oct 22, 2022
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
K213804 · QQX
Roche Molecular Systems, Inc.
Microbiology · 320d
Cleared Oct 22, 2022
Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with...
K222058 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 102d
Cleared Oct 21, 2022
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU...
K210414 · FYC
Medtecs (Taiwan) Corp.
General Hospital · 617d
Cleared Oct 21, 2022
MCI-Neuro Fixation System
K212391 · GWO
Mci Medical Concept Innovation, Inc.
Neurology · 445d
Cleared Oct 21, 2022
IntraOp VSP Software Device
K213128 · LLZ
Xironetic, LLC
Radiology · 389d
Cleared Oct 21, 2022
Enteral Transition Adaptor
K220165 · PIO
GBUK Group, Ltd.
Gastroenterology & Urology · 274d
Cleared Oct 21, 2022
Onetouch Non-paraben Lubricant Gel
K220273 · NUC
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 263d
Cleared Oct 21, 2022
NextDent Ortho Flex
K221022 · MQC
Vertex-Dental B.V.
Dental · 198d
Cleared Oct 21, 2022
PureLift Pro Plus
K221443 · NFO
Xtreem Pulse, LLC
Neurology · 156d
Cleared Oct 21, 2022
DePuy Reclaim Monobloc Revision Femoral Stem
K221462 · LZO
Depuy Ireland UC
Orthopedic · 155d
Cleared Oct 21, 2022
Hair Removal Device (Model: IPL-D26, IPL-D19)
K221643 · OHT
Shenzhen Desida Technology Co., Ltd.
General & Plastic Surgery · 137d
Cleared Oct 21, 2022
NuVasive Cohere ALIF System Intervertebral Body Fusion Device
K221751 · OVD
Nu Vasive, Incorporated
Orthopedic · 127d