FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
12457–12480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2022
Disposable Surgical Gown UM-148
K221717 · FYA
Unimax Medical Products Co., Ltd.
General Hospital · 99d
Cleared Sep 20, 2022
DePuy Synthes 3.5mm Intrapelvic Acetabular System
K221809 · HRS
DePuy Synthes
Orthopedic · 90d
Cleared Sep 20, 2022
JO CUMPLAY Personal Lubricant
K221908 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 82d
Cleared Sep 20, 2022
Surgical Face Mask (Non-sterile)
K221976 · FXX
Xiantao Junhui Plastic Products Co.,...
General Hospital · 77d
Cleared Sep 20, 2022
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
K222642 · LZA
Inner Mongolia Cureguard Medical...
General Hospital · 19d
Cleared Sep 19, 2022
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
K213013 · QNQ
Jeil Tech Co., Ltd.
General Hospital · 364d
Cleared Sep 19, 2022
Pro M Class
K213897 · EKX
Saeyang Microtech Co., Ltd.
Dental · 279d
Cleared Sep 19, 2022
LANDMARK REBOA Catheter
K214060 · MJN
Zien Medical Technologies, Inc.
Cardiovascular · 266d
Cleared Sep 19, 2022
Promisemed X-Safety Pen Needle
K220129 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 244d
Cleared Sep 19, 2022
Arthrex Compression FT Pins
K220839 · HWC
Arthrex, Inc.
Orthopedic · 180d
Cleared Sep 19, 2022
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
K221638 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 105d
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