FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
141409–141432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1986
VISION(TM) AMYLASE
K864435 · JFJ
Abbott Laboratories
Chemistry · 34d
Cleared Dec 16, 1986
KOKEN'S NEW MODEL M-3000 POWER TABLE
K864501
Koken Mfg Company, Inc.
Physical Medicine · 32d
Cleared Dec 16, 1986
LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36
K864529 · GDY
Elof Hansson, Inc.
General & Plastic Surgery · 29d
Cleared Dec 16, 1986
IQ T4 IMMUNOASSAY
K864560 · CDX
Bd Becton Dickinson Vacutainer...
Chemistry · 27d
Cleared Dec 16, 1986
ALT WHEELCHAIR
K864573 · IOR
Alt Design
Physical Medicine · 26d
Cleared Dec 16, 1986
ADOBE ENTERPRISES SURGICAL/BANDAGE SCISSORS FORCEP
K864608 · GEN
Adobe Ent.
General & Plastic Surgery · 22d
Cleared Dec 16, 1986
MODIFIED DUAL LUMEN NEEDLE
K864629 · LBW
Quinton, Inc.
Gastroenterology & Urology · 21d
Cleared Dec 16, 1986
ACTIVE LIGHTWEIGHT WHEELCHAIR
K864684 · IOR
A-Bec Mobility, Inc.
Physical Medicine · 14d
Cleared Dec 16, 1986
SCOOTA MOTORIZED VEHICLE
K864686 · INI
A-Bec Mobility, Inc.
Physical Medicine · 14d
Cleared Dec 16, 1986
I.V. START KITS
K864693
Salt Creek Medical Technologies
General & Plastic Surgery · 14d
Cleared Dec 16, 1986
USI AUTOJECT INSULIN SYRINGE
K864761 · FMF
Ulster Scientific, Inc.
General Hospital · 11d
Cleared Dec 15, 1986
FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM
K861692 · IZH
Fischer Imaging Corp.
Radiology · 227d
Cleared Dec 15, 1986
ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT
K862017 · HRX
Dyonics, Inc.
Orthopedic · 201d
Cleared Dec 15, 1986
MULTISPIRO SA/100
K863134 · BZG
Biotrine Corp.
Anesthesiology · 122d
Cleared Dec 15, 1986
NO-FLO I
K863613 · CCN
Design Technologies, Inc.
Anesthesiology · 90d
Cleared Dec 15, 1986
BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT
K863743 · DHB
Immuno Nuclear Corp.
Immunology · 82d
Cleared Dec 15, 1986
BIRD NIGHTBIRD NASAL CPAP SYSTEM
K863746 · BZD
Bird Products Corp.
Anesthesiology · 82d
Cleared Dec 15, 1986
VIS-CUBE HCG (EIA)
K863933 · JHI
Leeco Diagnostics, Inc.
Chemistry · 68d
Cleared Dec 15, 1986
PORTABLE LIQUID OXYGEN UNIT (MODIFICATION)
K863978 · BYJ
Penox Technologies, Inc.
Anesthesiology · 62d
Cleared Dec 15, 1986
OPEN RESERVOIR SCAVENGER
K864034 · CBN
Draeger Medical, Inc.
Anesthesiology · 61d
Cleared Dec 15, 1986
VES-10 INTRAOCULAR SCISSORS DRIVE
K864035 · HQE
Trek Medical Products, Inc.
Ophthalmic · 60d
Cleared Dec 15, 1986
ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T
K864043 · BZT
Respiratory Support Products, Inc.
Anesthesiology · 60d
Cleared Dec 15, 1986
BKS-42 DISPOSABLE VACUUM TUBING PACK
K864065 · HNO
Allergan, Inc.
Ophthalmic · 56d
Cleared Dec 15, 1986
ANTI-NDNA ANTIBODY TEST KIT
K864275 · KTL
Cappel Diagnostics, Inc.
Immunology · 47d