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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
158593–158616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1983
URITEST 9, INLAB REAGENT STRIPS URINALY
K822709 · JMA
Laprol Scientific, Inc.
Chemistry · 143d
Cleared Jan 28, 1983
NEPHROSTOMY CATHETER
K823382 · LJE
Umi, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 28, 1983
SURGICAL GAUZE
K823455
Worldwide Surgical Gauze
General & Plastic Surgery · 71d
Cleared Jan 28, 1983
INTRA-ARTICULAR C02 INSUFFLATOR
K823499 · HRX
Surgical Instrument Repair Service Co.
Orthopedic · 65d
Cleared Jan 28, 1983
CYCLIC ADENOSINE MONOPHOSHATE BY RADIO
K823504 · CHO
Immuno Nuclear Corp.
Chemistry · 65d
Cleared Jan 28, 1983
DILUENT, ZEROING SOLUTION & CO-OX/ISE
K823535 · JKT
Shaban Mfg. Co.
Toxicology · 59d
Cleared Jan 28, 1983
SPIROTECH 300
K823771 · BTY
Spirotech, Inc.
Anesthesiology · 45d
Cleared Jan 28, 1983
ULTRAZYME PLUS GAMMA-GT, #64959/65032
K823883 · JQB
Emd Chemicals, Inc.
Chemistry · 32d
Cleared Jan 28, 1983
ADVANCE EMIT CAD DISOPYRAMIDE ASSAY
K823887 · KLR
Syva Co.
Toxicology · 32d
Cleared Jan 28, 1983
COLLAR BUTTON VENT TUBE
K823907 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 31d
Cleared Jan 28, 1983
GROMMET VENT TUBE
K823908 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 31d
Cleared Jan 28, 1983
MULTIANALYTE CONTROLS-ALL KINDS
K823929 · JJY
Fisher Scientific Co., LLC
Chemistry · 30d
Cleared Jan 28, 1983
CPAP INFANT NASAL CANNULAE SET
K823936 · BZD
Ackrad Laboratories
Anesthesiology · 30d
Cleared Jan 28, 1983
WAKO INSULIN TEST
K823939 · CFP
Wako Chemicals USA, Inc.
Chemistry · 30d
Cleared Jan 28, 1983
ACRYLIC SHEET, PLEXIGLASS MC
K830031
Summit Orthodontic Services, Inc.
Dental · 21d
Cleared Jan 28, 1983
TOTAL IRON BINDING CAPACITY TEST
K830032 · JQF
Sclavo, Inc.
Chemistry · 21d
Cleared Jan 28, 1983
SOPHEIA DIGITOXIN EIA KIT & COMPONENTS
K830035 · LFM
Diagnostic Products Corp.
Chemistry · 21d
Cleared Jan 28, 1983
NEONATAL NTSH RADIOIMMUNOASSAY SYS
K830036 · JLW
Corning Medical & Scientific
Chemistry · 21d
Cleared Jan 28, 1983
ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL
K830049 · LAS
Syva Co.
Chemistry · 18d
Cleared Jan 28, 1983
COLLAR BUTTON VENT TUBE
K830085 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Jan 28, 1983
USCI ELECTRONIC MANOMETER
K830093 · DRS
C.R. Bard, Inc.
Cardiovascular · 17d
Cleared Jan 28, 1983
RAPID CHEM ANALYZER II
K830095 · JJF
Macomb Chemical Co.
Toxicology · 17d
Cleared Jan 28, 1983
PHADEBAS & PHADEZYME RAST ALLERGEN DISC
K830096 · DHB
Pharmacia, Inc.
Chemistry · 17d
Cleared Jan 28, 1983
AUFRANC-TURNER ATS METAL BACKED ACETABU
K830097 · DXQ
Howmedica Corp.
Cardiovascular · 17d