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
12193–12216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2022
35g Standard SMMS Surgical Gown
K221819 · FYA
Winner Medical Co., Ltd.
General Hospital · 88d
Cleared Sep 19, 2022
Lancet
K221839 · FMK
Hebei Xinle Sci&Tech Co., Ltd.
General & Plastic Surgery · 87d
Cleared Sep 19, 2022
C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD...
K222121 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 63d
Cleared Sep 19, 2022
NB 1 SA Implant System
K222131 · DZE
Arum Dentistry Co., Ltd.
Dental · 63d
Cleared Sep 16, 2022
Nexpowder
K202929 · QAU
Nextbiomedical Co., Ltd.
General & Plastic Surgery · 717d
Cleared Sep 16, 2022
Altus Spine Pedicle Screw System
K211027 · NKB
Altus Partners, LLC
Orthopedic · 528d
Cleared Sep 16, 2022
Tempo Smart Button
K212217 · QOG
Eli Lilly and Company
General Hospital · 427d
Cleared Sep 16, 2022
AllureTM Surgical Mask
K212926 · FXX
Allure Gift Wraps Private Limited
General Hospital · 367d
Cleared Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2,...
K220134 · CFR
Roche Diagnostics
Chemistry · 241d
Cleared Sep 16, 2022
True Tulip, True M.I.S.
K220297 · NKB
Innovative Surgical Designs, Inc.
Orthopedic · 226d
Cleared Sep 16, 2022
Esthetic Abutments Nobel Biocare N1
K220339 · NHA
Nobel Biocare Services AG
Dental · 221d
Cleared Sep 16, 2022
CYGNUS™ MoRe Anterior Cervical Plate System
K220441 · KWQ
MiRus, LLC
Orthopedic · 212d
Cleared Sep 16, 2022
Neuro Omega System, NeuroSmart System
K220553 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 200d
Cleared Sep 16, 2022
GelPOINT V-Path Vaginal Access System
K220969 · MOK
Applied Medical Resources Corporation
Obstetrics & Gynecology · 165d
Cleared Sep 16, 2022
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion...
K221074 · GEI
Stryker Corporation
General & Plastic Surgery · 157d
Cleared Sep 16, 2022
LEDEX
K221194 · EBZ
Dentmate Technology Co. , Ltd.
Dental · 144d
Cleared Sep 16, 2022
L1P-1F (TRIOS 5)
K221249 · NBL
3Shape TRIOS A/S
Dental · 137d
Cleared Sep 16, 2022
ECHELON ENDOPATH Staple Line Reinforcement
K221343 · OXC
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 130d
Cleared Sep 16, 2022
Surgical Face Masks (Ear Loops And Tie-On)
K221534 · FXX
San-M Package Co., Ltd.
General Hospital · 112d
Cleared Sep 16, 2022
Exsalta
K221676 · BTA
Drw Medical
General & Plastic Surgery · 99d
Cleared Sep 16, 2022
Electric Wheelchair, Model: 9000N
K221799 · ITI
Silver Fox Corporation Limited
Physical Medicine · 87d
Cleared Sep 16, 2022
Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket...
K222155 · PNR
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 58d
Cleared Sep 16, 2022
ClearPoint System
K222519 · HAW
ClearPoint Neuro, Inc.
Neurology · 28d
Cleared Sep 15, 2022
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
K203336 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 672d