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
22057–22080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2019
Intra.Ox 2.0 Handheld Tissue Oximeter
K191676 · MUD
Vioptix, Inc.
General & Plastic Surgery · 84d
Cleared Sep 16, 2019
PicoWay Laser System
K191685 · GEX
Candela Corporation
General & Plastic Surgery · 84d
Cleared Sep 16, 2019
SubtleMR
K191688 · LLZ
Subtle Medical, Inc.
Radiology · 84d
Cleared Sep 16, 2019
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with...
K191800 · LZA
Kossan International Sdn Bhd
General Hospital · 75d
Cleared Sep 15, 2019
0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
K191378 · NGT
Medline Industries, Inc.
General Hospital · 115d
Cleared Sep 13, 2019
Roosin Xeroform Petrolatum Dressing
K181478 · FRO
Roosin Medical Co., Ltd.
General & Plastic Surgery · 465d
Cleared Sep 13, 2019
Infinix Universal Composite
K182921 · EBF
Nobio , Ltd.
Dental · 329d
Cleared Sep 13, 2019
Bellavista
K183364 · CBK
Imtmedical AG
Anesthesiology · 283d
Cleared Sep 13, 2019
CapMedic
K183586 · CAF
Cognita Labs, LLC
Anesthesiology · 266d
Cleared Sep 13, 2019
Vexillum Zephyr (olifilcon A) with Tangible Polymers...
K183670 · LPL
Visco Vision, Inc.
Ophthalmic · 260d
Cleared Sep 13, 2019
Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
K190005 · MLR
Sterilucent, Inc.
General Hospital · 254d
Cleared Sep 13, 2019
Arthrex Tenodesis Button
K190288 · MBI
Arthrex, Inc.
Orthopedic · 214d
Cleared Sep 13, 2019
ACIST RXi System and Navvus II Catheter
K190473 · OBI
Acist Medical Systems, Inc.
Cardiovascular · 198d
Cleared Sep 13, 2019
TDM Screw Systems
K190830 · HWC
Tdm Co., Ltd.
Orthopedic · 165d
Cleared Sep 13, 2019
SCENARIA View
K190841 · JAK
Hitachi Healthcare Americas
Radiology · 165d
Cleared Sep 13, 2019
Pulse Oximeter
K190869 · DQA
Shenzhen Aeon Technology Co., Ltd.
Anesthesiology · 163d
Cleared Sep 13, 2019
RFID Localization System
K190932 · NEU
Health Beacons, Inc.
General & Plastic Surgery · 156d
Cleared Sep 13, 2019
Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape,...
K191021 · FRC
Terragene S.A.
General Hospital · 149d
Cleared Sep 13, 2019
Multi-Link X2 ECG and SpO2 Adapter
K191273 · DSA
Vyaire Medical, Inc.
Cardiovascular · 123d
Cleared Sep 13, 2019
JuggerStitch Meniscal Repair Device
K191459 · MBI
Biomet, Inc.
Orthopedic · 102d
Cleared CT Sep 13, 2019
ARCHITECT STAT High Sensitivity Troponin-I
K191595 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 88d
Cleared Sep 13, 2019
NICO Myriad NOVUS
K191599 · GEI
Nico Corporation
Obstetrics & Gynecology · 88d
Cleared Sep 13, 2019
PROBEAT-CR
K191801 · LHN
Hitachi , Ltd.
Radiology · 72d
Cleared Sep 13, 2019
UNFOLDER Vitan Inserter
K191949 · MSS
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 53d