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
143281–143304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 20, 1986
PORTABLE ISOKINETICS 3004 KNEE UNIT
K862996 · IKK
Kent Design & Manufacturing, Inc.
Physical Medicine · 12d
Cleared Aug 20, 1986
PORTABLE ISOKINETICS 3005 HIP UNIT
K862997 · IKK
Kent Design & Manufacturing, Inc.
Physical Medicine · 12d
Cleared Aug 20, 1986
PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT
K862998 · IKK
Kent Design & Manufacturing, Inc.
Physical Medicine · 12d
Cleared Aug 20, 1986
PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
K863033 · BZO
Intertech/Ohio
Anesthesiology · 9d
Cleared Aug 19, 1986
PRISTINE CULTURE CATHETER
K860325 · KOD
Hall/Mccollum Laboratories, Inc.
Gastroenterology & Urology · 202d
Cleared Aug 19, 1986
SEAMED MODEL 3000
K860462 · DTC
Seamed Corp.
Cardiovascular · 194d
Cleared Aug 19, 1986
ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT
K860823 · CFT
Cis-Us, Inc.
Chemistry · 168d
Cleared Aug 19, 1986
WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS)
K860909 · HIS
U. C. Import & Co.
Obstetrics & Gynecology · 162d
Cleared Aug 19, 1986
WAKO MICRO TP
K861508 · CEK
Wako Chemicals USA, Inc.
Chemistry · 118d
Cleared Aug 19, 1986
MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER
K861623 · FLL
Luxtron
General Hospital · 112d