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
137929–137952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1987
MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.
K873887 · KDI
W.R. Grace & Co.-Conn.
Gastroenterology & Urology · 77d
Cleared Dec 09, 1987
MERITEC(TM)-GC
K874078 · LIC
Meridian Diagnostics, Inc.
Microbiology · 64d
Cleared Dec 09, 1987
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
K874466 · JWY
Analytical Products, Inc.
Microbiology · 37d
Cleared Dec 09, 1987
PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)
K874650 · FKO
Quinton, Inc.
Gastroenterology & Urology · 26d
Cleared Dec 08, 1987
BESTCON/SPERMICIDE
K871451 · HIS
Europharmaceutical Corp.
Obstetrics & Gynecology · 239d
Cleared Dec 08, 1987
AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR
K872645 · LRB
Richards Medical Co., Inc.
Ear, Nose, Throat · 155d
Cleared Dec 08, 1987
KIMONO (CONDOMS)
K872799 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 146d
Cleared Dec 08, 1987
HEARING AID (ALL-IN-THE-EAR)
K873003 · ESD
Acoustical Hearing Services, Inc.
Ear, Nose, Throat · 126d
Cleared Dec 08, 1987
SERVICE MASTER (IMPULSE)
K873300 · LRB
Richards Medical Co., Inc.
Ear, Nose, Throat · 112d
Cleared Dec 08, 1987
NICOLET DIGITAL TWO PIECE HEARING AID
K873736 · ESD
Nicolet Biomedical Instruments
Ear, Nose, Throat · 84d
Cleared Dec 08, 1987
BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE
K873763 · LYC
Geistlich-Pharma
Dental · 83d
Cleared Dec 08, 1987
JDM SP2 SENSOR
K873806 · KMI
Jd Monitoring C/O Mackler, Cooper and...
General Hospital · 81d
Cleared Dec 08, 1987
MOTHER'S MILK BAG
K874071 · HGX
Yanase Waitch K.K.
Obstetrics & Gynecology · 63d
Cleared Dec 08, 1987
RIGID-LENS CASE
K874657 · LRX
Sola Ophthalmics
Ophthalmic · 19d
Cleared Dec 08, 1987
STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX)
K874718 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 21d
Cleared Dec 07, 1987
COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION
K871490 · DPW
Ge Medical Systems Information...
Cardiovascular · 237d
Cleared Dec 07, 1987
BIO-MEDICUS CANNULA-TUBING
K872033 · DWF
Bio Medicus, Inc.
Cardiovascular · 194d
Cleared Dec 07, 1987
ENVIRACAIRE MODEL EV-1
K872359 · FRF
Enviracaire Corp.
General Hospital · 172d
Cleared Dec 07, 1987
BIOMA 3500
K872370 · KRC
E.B.S., Inc.
Cardiovascular · 171d
Cleared Dec 07, 1987
UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
K872715 · JDN
Roseburg SA
Orthopedic · 150d
Cleared Dec 07, 1987
ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM
K873343 · KNT
Entech, Inc.
Gastroenterology & Urology · 110d
Cleared Dec 07, 1987
FOLEY CATHETER TEMPERATURE SENSOR
K873448 · KOD
Respiratory Support Products, Inc.
Gastroenterology & Urology · 103d
Cleared Dec 07, 1987
HI-NEK TOTAL HIP
K873632 · JDI
Orthopedic Systems, Inc.
Orthopedic · 90d
Cleared Dec 07, 1987
MODIFIED DSP100 AMPLIFIER
K873640 · DQC
Intl. Acoustics, Inc.
Cardiovascular · 89d