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
25177–25200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2018
Duo™ Lumbar Interbody Fusion Device
K181792 · MAX
Spineology, Inc.
Orthopedic · 40d
Cleared Aug 14, 2018
WiScope Digital Endoscope System
K181977 · FGB
OTU Medical, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 14, 2018
PleuraFlow System with FlowGlide Extra Drainage Length
K182067 · OTK
Clearflow, Inc.
General & Plastic Surgery · 13d
Cleared Aug 13, 2018
Pulse Oximeter
K173123 · DQA
Shenzhen Imdk Medical Technology Co.,...
Anesthesiology · 318d
Cleared Aug 13, 2018
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
K173498 · OZZ
Diasorin Molecular, LLC
Microbiology · 273d
Cleared Aug 13, 2018
BIAFINE
K173549 · FRO
Valeant Pharmaceuticals
General & Plastic Surgery · 270d
Cleared Aug 13, 2018
Deformity Analysis and Correction Software (DACS) and Instrumentation
K180539 · OSN
Arrowhead Medical Device...
Orthopedic · 166d
Cleared Aug 13, 2018
KLS Martin Individual Patient Solutions
K180962 · JEY
KLS-Martin L.P.
Dental · 123d
Cleared Aug 13, 2018
TirboLOX-L Lumbar IBFD
K180990 · MAX
Captiva Spine, Inc.
Orthopedic · 119d
Cleared Aug 13, 2018
ONIS-PACS
K181318 · LLZ
Digitalcore Co., Ltd.
Radiology · 87d
Cleared Aug 13, 2018
Vantage Galan 3T, MRT-3020/A7, V5.0
K181593 · LNH
Canon Medical Systems Corporation
Radiology · 56d
Cleared Aug 13, 2018
Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
K181978 · NKB
Medyssey USA, Inc.
Orthopedic · 20d
Cleared Aug 11, 2018
CARDIOSKIN
K173248 · DXH
Bioserenity Sas
Cardiovascular · 305d
Cleared Aug 10, 2018
Diana Medication Transfer Set
K170110 · ONB
Icu Medical, Inc.
General Hospital · 575d
Cleared Aug 10, 2018
physiQ Heart Rhythm Module
K180234 · DPS
Physiq, Inc.
Cardiovascular · 193d
Cleared Aug 10, 2018
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
K180644 · LZA
Hartalega Sdn Bhd
General Hospital · 151d
Cleared Aug 10, 2018
CoreLink® M3™ Stand-Alone Anterior Lumbar System
K180814 · OVD
Corelink, LLC
Orthopedic · 134d
Cleared Aug 10, 2018
Altrix Precision Temperature Management System
K180834 · DWJ
Stryker Medical
Cardiovascular · 133d
Cleared Aug 10, 2018
Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy...
K181130 · LZC
Hebei Titans Hongsen Medical...
General Hospital · 102d
Cleared Aug 10, 2018
GYNECARE TVT Abbrevo Continence System
K181151 · PWJ
Ethicon, Inc.
General & Plastic Surgery · 101d
Cleared Aug 10, 2018
Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup
K181253 · OAP
Pjm Worldwide, LLC D/B/A Phoenix...
General & Plastic Surgery · 91d
Cleared Aug 10, 2018
Redi-Spine
K181584 · NKB
Innovative Surgical Designs, Inc.
Orthopedic · 56d
Cleared Aug 10, 2018
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One...
K181627 · MRC
Bausch & Lomb, Incorporated
Ophthalmic · 51d
Cleared Aug 10, 2018
iStim S2 OTC Pain Relief TENS
K181849 · NUH
Everyway Medical Instruments Co., Ldt.
Neurology · 30d