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

Filters: Cleared only ×
176,076 results
163201–163224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1981
LINDE MARK II
K812536 · BYJ
Union Carbide Corp.
Anesthesiology · 20d
Cleared Sep 23, 1981
PROTEIN-BASED BLOOD GAS CONTROL
K812541 · JJS
American Dade
Chemistry · 19d
Cleared Sep 23, 1981
BEAUBON
K812547 · DYH
Sci-Pharm, Inc.
Dental · 19d
Cleared Sep 23, 1981
BEAUCOR
K812551 · EBF
Sci-Pharm, Inc.
Dental · 19d
Cleared Sep 23, 1981
COROMETRICS MEDICAL SYST. 220 PH ANALY.
K812552 · CHL
Transidyne General Corp.
Chemistry · 19d
Cleared Sep 23, 1981
AQUEOUS BLOOD GAS CONTROLS
K812553 · JJS
Fisher Scientific Co., LLC
Chemistry · 15d
Cleared Sep 23, 1981
MEDTRONIC MODEL 2409
K812580 · DXY
Medtronic Vascular
Cardiovascular · 13d
Cleared Sep 23, 1981
SENSI-TECT
K812581 · JTZ
Uti-Tect, Inc.
Microbiology · 13d
Cleared Sep 23, 1981
CANCEL
K812582 · EXB
Bio Systems, Inc.
Gastroenterology & Urology · 13d
Cleared Sep 23, 1981
GER 540, GER 541 MANUAL BED
K812600 · FNJ
G.W. Healthcare, Inc.
General Hospital · 9d
Cleared Sep 21, 1981
SPECTACLE FRAMES
K810876 · HQZ
Fashionline Corp.
Ophthalmic · 174d
Cleared Sep 21, 1981
CAVITY VARNISH
K810913 · LBH
Dentsply Intl.
Dental · 168d
Cleared Sep 21, 1981
THE EMMETT IUD THREAD RETRIEVER
K811761 · HHF
Proto-Med, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 21, 1981
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K811830 · KDI
Cordis Corp.
Gastroenterology & Urology · 84d
Cleared Sep 21, 1981
STERI-TRACT
K811863 · KDJ
Rogo Ent.
Gastroenterology & Urology · 82d
Cleared Sep 21, 1981
FORAMATRON APICAL FORAMEN LOCATOR
K811995
Parker Laboratories, Inc.
Dental · 70d
Cleared Sep 21, 1981
OXYGEN MONITOR 140/141
K812040 · CCL
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 62d
Cleared Sep 21, 1981
PORTAPULSE
K812131 · DRT
Gavon, Inc.
Cardiovascular · 55d
Cleared Sep 21, 1981
AIRE-CUF TRACHEOSTOMY TUBE
K812163 · JOH
Bioana Surgical Instruments, Inc.
Anesthesiology · 54d
Cleared Sep 21, 1981
ENDOCERVICAL ASPIRATOR
K812175 · HFC
Fertility Instrumentation, Inc.
Obstetrics & Gynecology · 49d
Cleared Sep 21, 1981
UNITEK PALATAL BAR
K812239 · DYT
Unitek Corp.
Dental · 41d
Cleared Sep 21, 1981
NIVP MONITOR
K812259 · DXN
Datascope Corp.
Cardiovascular · 40d
Cleared Sep 21, 1981
LINGUAL BRACKET
K812300 · EJF
American Ormco
Dental · 38d
Cleared Sep 21, 1981
USCI TRANSTHORACIC TEMP. PACING ELECTROD
K812307 · LDF
C.R. Bard, Inc.
Cardiovascular · 35d