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
12553–12576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2022
dS Sentinelle Breast 16ch 3.0T Coil
K213727 · MOS
Invivo Corporation (Business Trade...
Radiology · 255d
Cleared Aug 08, 2022
dS Sentinelle Breast 16ch 1.5T Coil
K213735 · MOS
Invivo Corporation (Business Trade...
Radiology · 252d
Cleared Aug 08, 2022
Dental Impression Material
K221668 · ELW
Chemoment Materials Co.,Ltd
Dental · 61d
Cleared Aug 08, 2022
Dolphin Imaging 12.0
K222072 · LLZ
Patterson Dental Supply, Inc.
Radiology · 25d
Cleared Aug 06, 2022
Pro Guard Nitrile Powder Free Examination Glove
K213934 · LZA
Medical Glove Co., Ltd.
General Hospital · 233d
Cleared Aug 06, 2022
Reprocesses Umbilical Cable
K221854 · NLH
Innovative Health, LLC
Cardiovascular · 40d
Cleared Aug 05, 2022
MONOFIX PGCL, knotless wound closure device
K212810 · GAM
Samyang Holdings Corp., Ltd.
General & Plastic Surgery · 336d
Cleared Aug 05, 2022
Unispace SA Cervical Cage
K213791 · OVE
Edisoninno Co., Ltd.
Orthopedic · 242d
Cleared Aug 05, 2022
Spineology Navigation Instruments
K213876 · OLO
Spineology, Inc.
Orthopedic · 235d
Cleared Aug 05, 2022
Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
K213993 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 227d
Cleared Aug 05, 2022
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K220045 · LPL
Dk Medivision Co., Ltd.
Ophthalmic · 212d
Cleared Aug 05, 2022
FAMA Male Latex Condoms
K220576 · HIS
Shanghai Personage Hygiene Products...
Obstetrics & Gynecology · 158d
Cleared Aug 05, 2022
Avéli
K221336 · OUP
Revelle Aesthetics, Inc.
General & Plastic Surgery · 88d
Cleared Aug 05, 2022
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with...
K221350 · LZA
Rubberex Alliance Products Sdn Bhd
General Hospital · 87d
Cleared Aug 05, 2022
Neurophet SCALE PET
K221405 · LLZ
Neurophet., Inc.
Radiology · 81d
Cleared Aug 04, 2022
CenterMed Patient Matched Assisted Surgical Planning (ASP) System
K211614 · PBF
Centermed, Inc.
Orthopedic · 435d
Cleared Aug 04, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K220001 · DFH
Diazyme Laboratories, Inc.
Immunology · 212d
Cleared Aug 04, 2022
MDHearingAid app, MDHearingAid Smart hearing aids
K220303 · QDD
Mdhearingaid
Ear, Nose, Throat · 183d
Cleared Aug 04, 2022
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
K220524 · NUH
Well-Life Healthcare Limited
Neurology · 162d
Cleared Aug 04, 2022
Mini-ClotTriever Thrombectomy System
K220887 · QEW
Inari Medical
Cardiovascular · 129d
Cleared Aug 04, 2022
Actera™ hip system
K221104 · MEH
Conformis, Inc.
Orthopedic · 112d
Cleared Aug 04, 2022
MANTIS Clip
K221124 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 108d
Cleared Aug 04, 2022
Bloomi Smooth Water Based Lubricant
K221328 · NUC
The Bloomi Inc..
Obstetrics & Gynecology · 90d
Cleared Aug 04, 2022
exGraft, exGraft Carbon
K221628 · DSY
Peca Labs
Cardiovascular · 59d