FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
24433–24456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2018
REDAPT Modular Acetabular Shell
K182109 · LPH
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Nov 16, 2018
AdvantageRib Anterior System
K182179 · HRS
Sig Medical Corp.
Orthopedic · 95d
Cleared Nov 16, 2018
Stratum™ Foot Plating System
K182201 · HRS
Nextremity Solutions, Inc.
Orthopedic · 94d
Cleared Nov 16, 2018
hemochroma PLUS System
K182298 · GKR
Immunostics Inc.,
Hematology · 84d
Cleared Nov 16, 2018
Hair Boom 69
K182562 · OAP
Wontech
General & Plastic Surgery · 59d
Cleared Nov 16, 2018
OEC One
K182626 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 53d
Cleared Nov 16, 2018
Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3...
K182916 · MJN
Lemaitre Vascular
Cardiovascular · 29d
Cleared Nov 16, 2018
1.5T 16ch Breast Coil
K182958 · MOS
Neocoil, LLC
Radiology · 23d
Cleared Nov 16, 2018
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
K182980 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 18d
Cleared Nov 15, 2018
K2 Zirkon Blank white classic
K173971 · EIH
Yeti Dentalprodukte GmbH
Dental · 321d
Cleared Nov 15, 2018
Amsel Endo Occluder
K180650 · FZP
Amsel Medical Corporation
General & Plastic Surgery · 247d
Cleared Nov 15, 2018
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
K180668 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 246d
Cleared Nov 15, 2018
PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
K181292 · EOX
Cogentix Medical, Inc.
Ear, Nose, Throat · 183d
Cleared Nov 15, 2018
FilmArray Pneumonia Panel plus
K181324 · QDS
Biofire Diagnostics, LLC
Microbiology · 181d
Cleared Nov 15, 2018
Nexcomp
K181689 · EBF
Meta Biomed Co., Ltd.
Dental · 142d
Cleared Nov 15, 2018
SITZMARKS
K181750 · FFX
Konsyl Pharmaceuticals
Gastroenterology & Urology · 136d
Cleared Nov 15, 2018
IntelliVue Multi-Measurement Module MMX
K181831 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 129d
Cleared Nov 15, 2018
Reprocessed Marinr Diagnostic EP Catheter
K181897 · NLH
Innovative Health, LLC
Cardiovascular · 122d
Cleared Nov 15, 2018
Voluson E6, Voluson E8, Voluson E10
K181985 · IYN
Ge Healthcare
Radiology · 113d
Cleared Nov 15, 2018
CardioBand ECG Event Recorder
K181998 · DPS
Samsung Strategy and Innovation...
Cardiovascular · 112d
Cleared Nov 15, 2018
YUKON OCT Spinal System
K182182 · NKG
K2m
Orthopedic · 94d
Cleared Nov 15, 2018
CanGaroo Neuro Envelope (small)
K182255 · FTM
Aziyo Biologics, Inc.
General & Plastic Surgery · 87d
Cleared Nov 15, 2018
Nitrile Glove Powder Free Black
K182528 · LZA
Haining Medical Products Co., Ltd.
General Hospital · 62d
Cleared Nov 15, 2018
PathLoc-L MIS Spinal System
K183117 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 6d