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
141433–141456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1986
RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE
K864290 · HNN
Keeler Instruments, Inc.
Ophthalmic · 45d
Cleared Dec 15, 1986
SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD)
K864301 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 45d
Cleared Dec 15, 1986
YANNUZZI FUNDUS LASER LENS
K864304 · HJK
Ocular Instruments, Inc.
Ophthalmic · 45d
Cleared Dec 15, 1986
PORTA RAY MODEL 325
K864339 · IZO
Porta Ray, Inc.
Radiology · 41d
Cleared Dec 15, 1986
LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER
K864369 · HJB
Heidelberg Instruments
Ophthalmic · 40d
Cleared Dec 15, 1986
EMERSON 3MV VOLUME VENTILATOR
K864379 · CBK
J. H. Emerson Co.
Anesthesiology · 40d
Cleared Dec 15, 1986
HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN
K864467 · HOO
Keeler Instruments, Inc.
Ophthalmic · 33d
Cleared Dec 15, 1986
LEG HOLDER
K864476 · HRX
American Container Technology, Inc.
Orthopedic · 32d
Cleared Dec 15, 1986
MODEL 6500 OPTHALMIC CHAIR
K864494 · HME
Koken Mfg Company, Inc.
Ophthalmic · 31d
Cleared Dec 15, 1986
MAC 150E OPTHALMIC CHAIR
K864574 · HME
Koken Mfg Company, Inc.
Ophthalmic · 25d
Cleared Dec 15, 1986
CANCELLOUS BONE SCREW
K864626 · HWC
Dow Corning Wright
Orthopedic · 20d
Cleared Dec 12, 1986
CREATINKINETIC
K863079 · CGX
J. D. Assoc.
Chemistry · 122d
Cleared Dec 12, 1986
SYPH-TRUST
K863368 · GMQ
I.A.F. Production, Inc.
Microbiology · 100d
Cleared Dec 12, 1986
EUB-400 DIAGNOSTIC ULTRASOUND DEVICE
K863576 · IYO
Hitachi Medical Corp. of America
Radiology · 91d
Cleared Dec 12, 1986
MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS
K863667 · JWH
Depuy, Inc.
Orthopedic · 85d
Cleared Dec 12, 1986
MAINSTER RETINA LASER LENS
K863911 · HJK
Ocular Instruments, Inc.
Ophthalmic · 65d
Cleared Dec 12, 1986
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K863997 · FRN
Abbott Laboratories
General Hospital · 59d
Cleared Dec 12, 1986
IRAS PERIMETER
K864012 · HPJ
Randwal Instrument Co., Inc.
Ophthalmic · 58d
Cleared Dec 12, 1986
STERILABELS
K864015 · LDQ
Diversatronics, Inc.
General & Plastic Surgery · 58d
Cleared Dec 12, 1986
RAYLOR(TM) DISSECTING HOOK
K864425 · GDG
Cedar Surgical, Inc.
General & Plastic Surgery · 32d
Cleared Dec 12, 1986
MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS
K864517 · FRN
Medtronic Minimed
General Hospital · 25d
Cleared Dec 11, 1986
INTRAUTERINE CATHETER
K861305 · HDR
Ram Development
Obstetrics & Gynecology · 248d
Cleared Dec 11, 1986
DYMAX PERSONAL SCANNER
K862127 · IYO
Dymax Corp
Radiology · 190d
Cleared Dec 11, 1986
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
K862153 · FOZ
Arrow Intl., Inc.
General Hospital · 189d