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
164929–164952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1981
SR-IVOTRAY SPECIAL
K810524 · EHY
J. Aderer, Inc.
Dental · 19d
Cleared Mar 17, 1981
SR-IVOTRAY UNIVERSAL
K810525 · EHY
J. Aderer, Inc.
Dental · 19d
Cleared Mar 17, 1981
ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB
K810536 · JXR
The Perkin-Elmer Corp.
Toxicology · 19d
Cleared Mar 17, 1981
MODEL S10CTCM AUDITORY STIMULATOR
K810539 · GWJ
Grass Instrument Co.
Neurology · 18d
Cleared Mar 17, 1981
BETA LYSIN DISK
K810541 · JTO
Remel Co.
Microbiology · 18d
Cleared Mar 17, 1981
CARDIOPULMINARY BYPASS CATHETER CANNULA
K810548 · DWF
Dlp, Inc.
Cardiovascular · 15d
Cleared Mar 17, 1981
SKIN SCRUB TRAY
K810558 · HFD
Associated Medical Products Co.
Obstetrics & Gynecology · 15d
Cleared Mar 17, 1981
OPTI- SYSTEM
K810559 · BTT
Corpak Co.
Anesthesiology · 14d
Cleared Mar 17, 1981
TN-3000 EVOKED RESPONSE SYSTEM
K810560 · GWF
Tracor Northern, Inc.
Neurology · 14d
Cleared Mar 17, 1981
CARBON DIOXIDE (C02) MICROSURGICAL LASER
K810562 · HHR
Metricon, Ltd.
Obstetrics & Gynecology · 14d
Cleared Mar 17, 1981
QUINTON LTE ELECTRODE
K810563 · DRX
Quinton, Inc.
Cardiovascular · 14d
Cleared Mar 17, 1981
PARAFFIN EMBEDDING MEDIUM
K810568 · KEO
Surgipath Medical Industries, Inc.
Radiology · 14d
Cleared Mar 17, 1981
MARTIN TRACH-SECURE
K810575 · BTO
Diatek, Inc.
Anesthesiology · 14d
Cleared Mar 17, 1981
EARETTE HEARING AID(BEHING THE EAR)
K810576 · ESD
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Mar 17, 1981
FACT* HOME PREGNANCY TEST
K810581 · JHJ
Ortho Pharmaceutical Corp.
Chemistry · 14d
Cleared Mar 17, 1981
EMIT-TFG PRISMA THYROXINE ASSAY
K810586 · KLI
Syva Co.
Chemistry · 13d
Cleared Mar 17, 1981
CENTRIFI CHEM SYSTEM 400 ANALYZER
K810596 · JJE
Union Carbide Corp.
Chemistry · 11d
Cleared Mar 17, 1981
MACRO-VUE CARD TEST
K810597 · KLB
Bd Becton Dickinson Vacutainer...
Toxicology · 11d
Cleared Mar 17, 1981
EMIT-ST SERUM PHENCYCLIDINE ASSAY
K810601 · LCM
Syva Co.
Toxicology · 11d
Cleared Mar 17, 1981
CORNING 925 CHLORIDE METER
K810615 · JFS
Corning Medical & Scientific
Chemistry · 8d
Cleared Mar 17, 1981
HOLLISTER MALE URINARY INCONT. SYSTEM
K810708
Hollister, Inc.
Gastroenterology & Urology
Cleared Mar 16, 1981
NEMECTRODYN 8
K802804 · IPF
Nemectron Medical, Inc.
Physical Medicine · 131d
Cleared Mar 16, 1981
ELITE
K810246 · IPF
Bloomex International, Inc.
Physical Medicine · 46d
Cleared Mar 13, 1981
THROMBO-TEST (X)
K801054 · JPK
Medtro GmbH
Hematology · 312d