Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
52369–52392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2009
GEM HEART ONE/ONE+
K092576 · DPS
Gem-Med S.L.
Cardiovascular · 14d
Cleared Sep 03, 2009
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
K082939 · KNA
Cook Urological, Inc.
Obstetrics & Gynecology · 336d
Cleared Sep 03, 2009
DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
K083288 · LPL
Innova Vision, Inc.
Ophthalmic · 300d
Cleared Sep 03, 2009
KAPPA LIGHT CHAINS
K083602 · DFH
SENTINEL CH. SpA
Immunology · 272d
Cleared Sep 03, 2009
STAXX XD SYSTEM
K090315 · MQP
Spine Wave, Inc.
Orthopedic · 206d
Cleared Sep 03, 2009
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119,...
K090760 · JZO
Theratest Laboratories, Inc.
Immunology · 164d
Cleared Sep 03, 2009
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
K090846 · JLW
Perkinelmer, Inc.
Chemistry · 157d
Cleared Sep 03, 2009
COMFORT TWIN NASAL MASK
K091066 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 142d
Cleared Sep 03, 2009
ASCEND
K091155 · BXN
Neurometrix, Inc.
Anesthesiology · 135d
Cleared Sep 03, 2009
INSUFLOW DEWHEART
K091366 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 118d
Cleared Sep 03, 2009
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V...
K091495 · LQR
Olympus Medical Systems Corporation
Gastroenterology & Urology · 106d
Cleared Sep 03, 2009
CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH
K091537 · GEX
Cynosure, Inc.
General & Plastic Surgery · 100d
Cleared Sep 03, 2009
SPK SEALANT
K091632 · EBC
3M Company
Dental · 91d
Cleared Sep 03, 2009
VENUS DIAMOND FLOW
K091635 · EBF
Heraeus Kulzer, LLC
Dental · 91d
Cleared Sep 03, 2009
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC...
K091685 · FRG
Kimberly-Clark Corp.
General Hospital · 85d
Cleared Sep 03, 2009
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR...
K091861 · JGS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 76d
Cleared Sep 03, 2009
SPIROPRO
K092324 · DQA
Viasys Healthcare GmbH
Anesthesiology · 30d
Cleared Sep 03, 2009
JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD).,...
K092332 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Sep 03, 2009
ICS CHARTR EP 200
K092373 · GWJ
Gn Otometrics
Neurology · 29d
Cleared Sep 03, 2009
STRONG IMPLANT HANDPIECES
K092412 · EFA
Saeshin Precision Co., Ltd.
Dental · 28d
Cleared Sep 02, 2009
WIENER LAB. URINE STRIP 10 AND 11
K083724 · JIO
Wiener Laboratorios Saic
Chemistry · 261d
Cleared Sep 02, 2009
IMRX
K091166 · LNH
Imris, Inc.
Radiology · 133d
Cleared Sep 02, 2009
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K091312 · JXG
Medtronic Neurosurgery
Neurology · 121d
Cleared Sep 02, 2009
GSO PCT SPINAL SYSTEM
K091359 · KWP
Gold Standard Orthopaedics, LLC
Orthopedic · 117d