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

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175,820 results
15985–16008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2021
Straumann CARES P-Series CAD/CAM System
K203750 · NHA
Institut Straumann AG
Dental · 290d
Cleared Oct 09, 2021
STERRAD 100NX Sterilizer with ALLClear Technology
K212174 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 89d
Cleared Oct 08, 2021
The Micro Screw System, Micro Screw System Basic
K201210 · DZL
Hager& Meisinger GmbH
Dental · 521d
Cleared Oct 08, 2021
B4C System
K201989 · GWM
Braincare Desenvolvimento E Inovacao...
Neurology · 448d
Cleared Oct 08, 2021
Infrared Thermometer (Model K9)
K203497 · FLL
Kangzhan Communication Electronics...
General Hospital · 315d
Cleared Oct 08, 2021
Clear Aligner
K203688 · NXC
Wuxi EA Medical Instruments...
Dental · 295d
Cleared Oct 08, 2021
INTEGRA Wound Matrix (Macro-Channels)
K210128 · KGN
Integra LifeSciences Corporation
General & Plastic Surgery · 262d
Cleared Oct 08, 2021
PuraStat-OM
K210211 · OLR
3-D Matrix, Inc.
General & Plastic Surgery · 254d
Cleared Oct 08, 2021
Single-Use Medical Face Mask
K210622 · FXX
Jiangxi Hongda Medical Equipment...
General Hospital · 220d
Cleared Oct 08, 2021
Medical Surgical Mask
K210813 · FXX
Sichuan Pharmaceutical., Inc.
General Hospital · 205d
Cleared Oct 08, 2021
Streamline Surgical System
K211680 · MRH
New World Medical, Inc.
Ophthalmic · 129d
Cleared Oct 08, 2021
Esophageal TTS Stent
K211706 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 127d
Cleared Oct 08, 2021
Medical Examination Gloves
K212078 · LZA
Guangdong Gymda Medical Technology...
General Hospital · 98d
Cleared Oct 08, 2021
ABCcolla Bone Matrix
K212156 · MQV
Acro Biomedical Co., Ltd.
Orthopedic · 88d
Cleared Oct 08, 2021
Cohitech Reusable Tampon Applicator
K212479 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 60d
Cleared Oct 08, 2021
ProLift Micro Expandable Spacer System
K212520 · MAX
Life Spine, Inc.
Orthopedic · 59d
Cleared Oct 08, 2021
Carescape SpO2 - Masimo
K212876 · DQA
Masimo Corporation
Cardiovascular · 29d
Cleared Oct 07, 2021
NeoMatriX Wound Matrix
K210024 · KGN
Nextgen Biologics, Inc.
General & Plastic Surgery · 276d
Cleared Oct 07, 2021
Superior Hair Remover
K210376 · OHT
Guangzhou Haoxingwan Technology Co.,...
General & Plastic Surgery · 240d
Cleared Oct 07, 2021
IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850,...
K210906 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 195d
Cleared Oct 07, 2021
Surgical Gown
K211077 · FYA
Wujiang Tutaike Textiles & Finishing...
General Hospital · 178d
Cleared Oct 07, 2021
Sterile syringes for single use with/without needle
K211211 · FMF
Azur Medical Company, Inc.
General Hospital · 167d
Cleared Oct 07, 2021
OASIS MRI System
K211406 · LNH
Hitachi Healthcare Americas
Radiology · 154d
Cleared Oct 07, 2021
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek...
K212065 · DPW
Remington Medical, Inc.
Cardiovascular · 97d