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
146281–146304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 1985
TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG
K852680 · HET
Multigon Industries, Inc.
Obstetrics & Gynecology · 181d
Cleared Dec 23, 1985
DIRECT ELISA FOR HERPES SIMPLEX VIRUS
K853307 · GQN
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 138d
Cleared Dec 23, 1985
SHAH SELF-CLEARING MASTOID SUCTION TUBE
K853589 · JZF
Downs Surgical , Ltd.
Ear, Nose, Throat · 118d
Cleared Dec 23, 1985
CRITIC C LEVEL I & II
K853943 · JJY
Dimension Diagnostics
Immunology · 90d
Cleared Dec 23, 1985
HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A
K854135 · IYO
Hewlett-Packard Co.
Radiology · 74d
Cleared Dec 23, 1985
CERAM-ETCH
K854494 · EBC
Gresco Products, Inc.
Dental · 41d
Cleared Dec 23, 1985
EPIDURAL ANESTHESIA TRAY
K854518 · CAZ
Omnis Surgical, Inc.
Anesthesiology · 41d
Cleared Dec 23, 1985
BIOGRAM
K854521 · JTZ
Giles Scientific, Inc.
Microbiology · 41d
Cleared Dec 23, 1985
TRANSPORT CULTURE MEDIA
K854715 · JSM
Hillcrest Biologicals
Microbiology · 31d
Cleared Dec 23, 1985
MICRO-MAT SYSTEM
K854962 · GKJ
Ulster Scientific, Inc.
Hematology · 12d
Cleared Dec 20, 1985
TENS
K850006
Zimmer Elektromedizin GmbH
Neurology · 352d
Cleared Dec 20, 1985
SUBDERM TM
K853635 · EGJ
General Medical Co.
Physical Medicine · 112d
Cleared Dec 20, 1985
AUDTEX 85
K853895 · ESD
Cami, Inc.
Ear, Nose, Throat · 91d
Cleared Dec 19, 1985
O.M.S. ULTRA-PHACO
K844373 · HQC
Optical Micro Systems, Inc.
Ophthalmic · 401d
Cleared Dec 19, 1985
THE HOOD LIFE SAVER
K853511 · BTO
Hood Laboratories
Anesthesiology · 120d
Cleared Dec 19, 1985
QUANTTEST TOTAL PROTEIN ASSAY
K853932 · CEK
Quantimetrix Corp.
Chemistry · 86d
Cleared Dec 19, 1985
IN VITRO TEST DETERMINATION OF THEOPHYLLINE
K854183 · KLS
Clinical Data, Inc.
Toxicology · 65d
Cleared Dec 19, 1985
ARI STANDARD ANESTHESIA RECORD
K854213 · BSZ
Agilent Technologies, Inc.
Anesthesiology · 63d
Cleared Dec 19, 1985
MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA
K854550 · CCQ
Medipart Jerry Alexander
Anesthesiology · 36d
Cleared Dec 19, 1985
MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S
K854551 · CCQ
Medipart Jerry Alexander
Anesthesiology · 36d
Cleared Dec 19, 1985
LONG TERM PERITONEAL CATHETER
K854614 · FJS
Thermadics, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 19, 1985
DSL ACTIVE TESTOSTERONE RIA (DSL #4000)
K854671 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 28d
Cleared Dec 19, 1985
DSL ANDROSTENDIONE RIA (DSL #4200)
K854674 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 28d
Cleared Dec 19, 1985
NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926
K854718 · CIX
Nobel Scientific Industries, Inc.
Chemistry · 27d