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
16297–16320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 2021
MagnetOs Easypack Putty
K211201 · MQV
Kuros Biosciences B.V
Orthopedic · 133d
Cleared Sep 02, 2021
Nitrile Examination Gloves, Green/ Blue/ Black Color
K211778 · LZA
Zhenjiang Suhui Latex Products Co., Ltd.
General Hospital · 85d
Cleared Sep 02, 2021
AI Segmentation
K211881 · MUJ
Varian Medical Systems, Inc.
Radiology · 73d
Cleared Sep 02, 2021
Air Relax Pro Model AR-4.0
K212491 · IRP
Diode Art Engineering Doing Business...
Physical Medicine · 24d
Cleared Sep 02, 2021
Lung Image Analysis
K212494 · JAK
Pulmonx Corporation
Radiology · 24d
Cleared Sep 01, 2021
EASYMAX Tag Self-Monitoring Blood Glucose System
K201258 · NBW
Eps Bio Technology Corp.
Chemistry · 478d
Cleared Sep 01, 2021
Tracheal Stent System
K202204 · JCT
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology · 392d
Cleared Sep 01, 2021
SP-1000, SP-2000
K202395 · IRP
Daesung Maref Co., Ltd.
Physical Medicine · 376d
Cleared Sep 01, 2021
EndoLIF Delta-Cage and DoubleWedge-Cage
K203014 · MAX
Joimax GmbH
Orthopedic · 335d
Cleared Sep 01, 2021
Numen Coil Embolization System
K203625 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 264d
Cleared Sep 01, 2021
Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter...
K210032 · DQA
Leadtek Research, Inc.
Anesthesiology · 239d
Cleared Sep 01, 2021
MeMed BV
K210254 · QPS
MeMed Diagnostics, Ltd.
Microbiology · 215d
Cleared Sep 01, 2021
Elecsys Vitamin D total III
K210901 · MRG
Roche Diagnostics
Chemistry · 159d
Cleared Sep 01, 2021
Leonardo Mini Blue
K210951 · GEX
Ceramoptec GmbH
General & Plastic Surgery · 155d
Cleared Sep 01, 2021
IPL Hair Removal
K211174 · OHT
Shenzhen Qiaochengli Technology Co.,...
General & Plastic Surgery · 134d
Cleared Sep 01, 2021
Evo sEEG System
K211367 · GZL
Neuroone Medical Technologies Corp.
Neurology · 120d
Cleared Sep 01, 2021
Welspun Health Surgical Mask
K211536 · FXX
Welspun India Limited
General Hospital · 106d
Cleared Sep 01, 2021
Disposable Medical Nitrile Gloves
K211673 · LZA
Changzhou Yihua Sanitation Material...
General Hospital · 92d
Cleared Sep 01, 2021
Bonine Acupressure Bands
K211823 · MVV
Wellspring Pharmaceutical Corporation
Neurology · 79d
Cleared Sep 01, 2021
Omeza Collagen Matrix
K211972 · FRO
Omeza, LLC
General & Plastic Surgery · 69d
Cleared Sep 01, 2021
Admiral ACP System
K212139 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 55d
Cleared Aug 31, 2021
Auto Lung Nodule Detection
K201560 · MYN
Samsung Electronics Co., Ltd.
Radiology · 447d
Cleared Aug 31, 2021
Ablamap Software
K203084 · DQK
Ablacon, Inc.
Cardiovascular · 322d
Cleared Aug 31, 2021
PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS,...
K203636 · FLL
Jkh USA, LLC
General Hospital · 260d