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

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175,820 results
137113–137136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1988
LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM
K872369 · IWM
Loma Linda University Medical Center
Radiology · 248d
Cleared Feb 22, 1988
A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH
K872525 · KPR
M.C. Johnson Co., Inc.
Radiology · 242d
Cleared Feb 22, 1988
DERMATOLOGICAL PATCH
K872926 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 210d
Cleared Feb 22, 1988
BAXTER BEDSIDE SYSTEM
K874181 · FRN
Travenol Laboratories, S.A.
General Hospital · 131d
Cleared Feb 22, 1988
S9 DISPLAY SYSTEM
K874214 · JAD
O.M.I. Oncology Microsystems, Inc.
Radiology · 129d
Cleared Feb 22, 1988
MODEL 492 SSR (TM) RECORDER
K874313 · DSH
Del Mar Avionics
Cardiovascular · 125d
Cleared Feb 22, 1988
MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)
K874480 · NAD
Omikron Scientific, Ltd.
General & Plastic Surgery · 112d
Cleared Feb 22, 1988
AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID
K874831 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Feb 22, 1988
PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER
K874877 · FNM
Pegasus Airwave, Inc.
General Hospital · 101d
Cleared Feb 22, 1988
SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.
K875063 · HQG
Epson EL Paso, Inc.
Ophthalmic · 75d
Cleared Feb 22, 1988
VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000
K875074 · KDP
Timeter Instrument Corp.
General Hospital · 75d
Cleared Feb 22, 1988
HERACURE LS 500
K875078 · HHR
W.C. Heraeus GmbH
Obstetrics & Gynecology · 55d
Cleared Feb 22, 1988
PB-A LEAD-ACID BATTERY CONVERSION KIT
K875106 · IZL
Diagnostic Imaging Specialists Corp.
Radiology · 70d
Cleared Feb 22, 1988
VICOR PACER, MODEL 410A
K880432 · DXY
Tpl-Cordis, Inc.
Cardiovascular · 25d
Cleared Feb 22, 1988
DERMGARD SYSTEM 800 AND 900
K880486 · IOQ
Dermgard, Inc.
Physical Medicine · 18d
Cleared Feb 22, 1988
MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH
K880583 · MPB
Quinton, Inc.
Gastroenterology & Urology · 13d
Cleared Feb 19, 1988
HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR
K872441 · DPT
Advanced Technology Laboratories, Inc.
Cardiovascular · 245d
Cleared Feb 19, 1988
STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT
K873926 · JEY
Storz Instrument Co.
Dental · 147d
Cleared Feb 19, 1988
ASD-BIO ANTI-STICK DEVICE
K874602 · FMI
Biosurge, Inc.
General Hospital · 102d
Cleared Feb 19, 1988
HOLLYWOODS COOL SHADES
K874722 · HQY
Tonka Corp.
Ophthalmic · 93d
Cleared Feb 19, 1988
IMMPULSE DIGOXIN ASSAY REAGENTS
K874748 · LCS
Sclavo, Inc.
Toxicology · 93d
Cleared Feb 19, 1988
RAPID COLORIMETRIC DIRECT STREP A TEST
K874761 · GTZ
New Horizons Diagnostics Co.
Microbiology · 92d
Cleared Feb 19, 1988
COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.
K874838 · GKZ
Coulter Electronics, Inc.
Hematology · 87d
Cleared Feb 19, 1988
LASERTRIPTER MINISCOPE
K874858 · ODF
Candela Laser Corp.
Gastroenterology & Urology · 86d