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
20881–20904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2020
Vesta RF Cannula
K190259 · GXI
Biomerics
Neurology · 365d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191298 · JFL
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Feb 07, 2020
Paragon XHD Diagnostic Ultrasound System
K191347 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 263d
Cleared Feb 07, 2020
Desara One Single Incision Sling System, 1 Pack
K191416 · PAH
Caldera Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Feb 07, 2020
Elefix V Paste for EEG & EMG
K191975 · GYB
Nihon Kohden Corporation
Neurology · 198d
Cleared Feb 07, 2020
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill...
K192273 · KLE
DiaDent Group International
Dental · 169d
Cleared Feb 07, 2020
Rochal Antimicrobial Wound Gel
K192527 · FRO
Rochal Industries, LLC
General & Plastic Surgery · 147d
Cleared Feb 07, 2020
NeoBase 2 Non-derivatized MSMS Kit
K193103 · NQL
Perkinelmer, Inc.
Chemistry · 91d
Cleared Feb 07, 2020
Yukon OCT Spinal System
K193129 · NKG
K2m, Inc.
Orthopedic · 87d
Cleared Feb 07, 2020
3M Attest Super Rapid 5 Steam-Plus Challenge Pack
K193154 · FRC
3M Company
General Hospital · 85d
Cleared Feb 07, 2020
Trevo NXT ProVue Retriever
K200117 · POL
Stryker
Neurology · 17d
Cleared Feb 06, 2020
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
K190800 · BTY
Cosmed Srl
Anesthesiology · 315d
Cleared Feb 06, 2020
Ancora Nerve Block Catheter Set
K191290 · BSP
Ancora Medical Technology
Anesthesiology · 269d
Cleared Feb 06, 2020
Ah!Yes Ob Coco Personal Lubricant
K191411 · NUC
Bio-Tech Lubricants, Ltd.
Obstetrics & Gynecology · 254d
Cleared Feb 06, 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
K191529 · NAY
Intuitive Surgical
General & Plastic Surgery · 241d
Cleared Feb 06, 2020
UV Radiation Treatment System
K191571 · FTC
Xuzhou Yongkang Electronic Science...
General & Plastic Surgery · 237d
Cleared Feb 06, 2020
Elos Accurate Customized Abutment
K191890 · NHA
Elos Medtech Pinol A/S
Dental · 206d
Cleared Feb 06, 2020
Lucy Point-of-Care Magnetic Resonance Imaging Device
K192002 · LNH
Hyperfine Research, Inc.
Radiology · 195d
Cleared Feb 06, 2020
VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single,...
K192757 · DRG
Vitalconnect, Inc.
Cardiovascular · 129d
Cleared Feb 06, 2020
MectaLock All-Suture Anchors
K193461 · MBI
Medacta International S.A.
Orthopedic · 52d
Cleared Feb 06, 2020
Steerable Plateau Ti
K193521 · MAX
Life Spine, Inc.
Orthopedic · 49d
Cleared Feb 06, 2020
BreathID Smart System
K193610 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 42d
Cleared Feb 05, 2020
Infinity / Infinity Cross Flex Dental Systems
K180935 · EIA
Olsen Industria E Comercio S.A.
Dental · 666d
Cleared Feb 05, 2020
Respire Pink AT (Hard, Hard/Soft, EF)
K192127 · LRK
Respire Medical Holdings
Dental · 183d