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
142681–142704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1986
ABRAHAM IRIDECTOMY LENS (YAG LASER)
K862713 · HKS
Ocular Instruments, Inc.
Ophthalmic · 36d
Cleared Aug 21, 1986
SOLARSHIELDS
K862719 · HQY
Dioptics
Ophthalmic · 35d
Cleared Aug 21, 1986
HOSKINS NYLON SUTURE LASER LENS
K862728 · HJK
Ocular Instruments, Inc.
Ophthalmic · 34d
Cleared Aug 21, 1986
INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES
K862739 · DSY
Intervascular, Inc.
Cardiovascular · 31d
Cleared Aug 21, 1986
CBC-CAL (TM) PLUS/MULTIPLE
K862858 · KRX
R&D Systems, Inc.
Hematology · 23d
Cleared Aug 21, 1986
ABRAHAM YAG LASER LENS
K862868 · HJK
Ocular Instruments, Inc.
Ophthalmic · 23d
Cleared Aug 21, 1986
PETRUS SINGLE MIRROR LASER LENS
K862869 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 23d
Cleared Aug 21, 1986
SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
K862943 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 16d
Cleared Aug 21, 1986
MERIVAARA GERIATRIC CHAIR MODEL 455
K862957 · INN
Global Medical Prods, Inc.
Physical Medicine · 15d
Cleared Aug 21, 1986
SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE
K862989 · HBC
Entronics
Neurology · 13d
Cleared Aug 21, 1986
SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS
K863027 · HJK
Ocular Instruments, Inc.
Ophthalmic · 10d
Cleared Aug 21, 1986
I.D.C. STANDUP WHEELCHAIRS
K863118 · IPL
Intl. Diffusion Consommateur
Physical Medicine · 7d
Cleared Aug 20, 1986
OEE_7102 EEG/TREND MONITOR
K854662 · GWS
Nihon Kohden America, Inc.
Neurology · 273d
Cleared Aug 20, 1986
NEUROFAX 7310 SERIES (EEG)
K854663 · GWQ
Nihon Kohden America, Inc.
Neurology · 273d
Cleared Aug 20, 1986
5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM
K860009 · ITX
Johnson & Johnson Professionals, Inc.
Radiology · 229d
Cleared Aug 20, 1986
AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)
K861014 · GWL
Amplaid USA, Inc.
Neurology · 155d
Cleared Aug 20, 1986
CABOT LASER LAPAROSCOPY ACCESSORY SET
K862228 · HHR
Cabot Medical Corp.
Obstetrics & Gynecology · 70d
Cleared Aug 20, 1986
MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K862831 · BSZ
Ohmeda Medical
Anesthesiology · 29d
Cleared Aug 20, 1986
WOUND MANAGER(TM) - STERILE
K862935 · NAD
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 16d
Cleared Aug 20, 1986
DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES
K862945
Downs Surgical , Ltd.
Orthopedic · 15d
Cleared Aug 20, 1986
MODIFIED SURGICAL STARTER KIT
K862961
Devon Industries, Inc.
General & Plastic Surgery · 16d
Cleared Aug 20, 1986
PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT
K862993 · IKK
Kent Design & Manufacturing, Inc.
Physical Medicine · 12d
Cleared Aug 20, 1986
PORTABLE ISOKINETICS 3002 ISO KANE II
K862994 · IKK
Kent Design & Manufacturing, Inc.
Physical Medicine · 12d
Cleared Aug 20, 1986
PORTABLE ISOKINETICS 3003 SHOULDER UNIT
K862995 · IKK
Kent Design & Manufacturing, Inc.
Physical Medicine · 12d