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
153841–153864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1984
DIACELIN
K840288 · GGN
Diatech, Inc.
Hematology · 90d
Cleared Apr 23, 1984
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305 · DWS
Imm Enterprises , Ltd.
Cardiovascular · 90d
Cleared Apr 23, 1984
CAT. 14-CLINICAL TOXIOLOGY DEVICES
K840318 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 90d
Cleared Apr 23, 1984
PACEMAKER PULSE GENERATOR W/ELECTRODE
K840353 · DRO
Ross Research, Inc.
Cardiovascular · 88d
Cleared Apr 23, 1984
SURG A STAT FINE TIP 5
K840493
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 77d
Cleared Apr 23, 1984
CRYO SURG 5900
K840536 · GEH
Frigitronics of Connecticut, Inc.
General & Plastic Surgery · 75d
Cleared Apr 23, 1984
NEURO SPONGE
K840541 · GDY
Surgicot, Inc.
General & Plastic Surgery · 75d
Cleared Apr 23, 1984
SURG-A-STAT FINE TIP 2
K840585 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 75d
Cleared Apr 23, 1984
LINEAR SCANNER 640
K840667 · IYO
Ge Medical Systems Information...
Radiology · 66d
Cleared Apr 23, 1984
FPP ARMBOARD STRAP
K840684 · FWZ
Fpp, Inc.
General & Plastic Surgery · 68d
Cleared Apr 23, 1984
STERILE ABSORBENT GAUZE BURN & SOUND
K840745 · FRO
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 61d
Cleared Apr 23, 1984
JANACEK TUBO-UTERINE IMPLANTATION SET
K840766 · HTD
Cimed Intl., Inc.
General & Plastic Surgery · 60d
Cleared Apr 23, 1984
STRAITH DRAIN INSERTER
K840835 · FZX
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 59d
Cleared Apr 23, 1984
SD PLUS PATIENT CAT.#78-8010
K840963 · GZJ
Codman & Shurtleff, Inc.
Neurology · 48d
Cleared Apr 23, 1984
SD PLUS CLINICIAN CAT# 78-8015
K840964 · GZJ
Codman & Shurtleff, Inc.
Neurology · 48d
Cleared Apr 23, 1984
CO2 LAPAROSCOPE
K841668
Laser Spectrum, Inc.
Gastroenterology & Urology
Cleared Apr 23, 1984
UTERINE MANIPULATOR 4.5MM
K841681
Humi Corp.
Obstetrics & Gynecology
Cleared Apr 20, 1984
DEAE-DEXTRAN IN PBS
K834116 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 143d
Cleared Apr 20, 1984
ULTRASOUND SCAN HEAD 3.5 MHZ
K834141 · IYO
Adr Ultrasound
Radiology · 121d
Cleared Apr 20, 1984
AMEDA PHOTOTHERAPY LAMP FOR NEWBORN
K834335 · LBI
Egnell, Inc.
General Hospital · 130d
Cleared Apr 20, 1984
CHEMLYTE
K834395 · FKQ
Diachem Laboratories
Gastroenterology & Urology · 128d
Cleared Apr 20, 1984
DRAINAGE STENT
K834468 · FGE
Microvasive
Gastroenterology & Urology · 122d
Cleared Apr 20, 1984
REAL FIBER OPTIC URETERAL TRANSILLUMIN
K834576 · FFS
Douglas Manufacturer Co.
Gastroenterology & Urology · 113d
Cleared Apr 20, 1984
IV-FILTER
K840248 · FPB
Tri-Med, Inc.
General Hospital · 92d