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

Filters: Cleared only ×
175,820 results
145081–145104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1986
SIMMONS SHELL
K855105 · HQT
Mira, Inc.
Ophthalmic · 98d
Cleared Mar 31, 1986
FUKUDA DENSHI CARDIMAX FCP-211
K860024 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 87d
Cleared Mar 31, 1986
VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015
K860149 · DWF
Dlp, Inc.
Cardiovascular · 75d
Cleared Mar 31, 1986
PRODIGY AND PRODIGY PLUS
K860167 · DSI
Cardiodata Corp.
Cardiovascular · 73d
Cleared Mar 31, 1986
AMI CARDIO-PAD
K860283 · DRO
Andover Medical, Inc.
Cardiovascular · 62d
Cleared Mar 31, 1986
TUBING CONNECTORS
K860291 · DTL
Biomedical Exports, Inc.
Cardiovascular · 62d
Cleared Mar 31, 1986
PERCUTANEOUS CATHETERS
K860339 · DQY
Micor, Inc.
Cardiovascular · 61d
Cleared Mar 31, 1986
PERCUTANEOUS INTRODUCER KIT
K860432 · DYB
Cormed, Inc., Sub. C.R.Bard, Inc.
Cardiovascular · 55d
Cleared Mar 31, 1986
(.O38) HI-TORQUE GUIDE WIRES
K860533 · DQX
Target Therapeutics
Cardiovascular · 47d
Cleared Mar 31, 1986
ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE
K860570 · KRA
Parke-Davis Co.
Cardiovascular · 45d
Cleared Mar 31, 1986
ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
K860580 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 41d
Cleared Mar 31, 1986
OPTHALMIC SURGICAL INSTRUMENTS
K860744 · HMX
Tridak Division of Indicon, Inc.
Ophthalmic · 32d
Cleared Mar 31, 1986
REGULATED PRESSURE INJECTOR
K860806 · DXF
Target Therapeutics
Cardiovascular · 27d
Cleared Mar 31, 1986
MODEL 366-08 ADAPTAID CONNECTOR ADAPTER
K860832 · DTD
Intermedics, Inc.
Cardiovascular · 26d
Cleared Mar 31, 1986
SPECTACLES FRAME
K860954 · HQZ
Roseburg SA
Ophthalmic · 18d
Cleared Mar 31, 1986
SPECTACLES LENS
K860955 · HQG
Roseburg SA
Ophthalmic · 18d
Cleared Mar 31, 1986
RARE EARTH INTRA-OCULAR MAGNET
K860960 · HPN
Ameritek, Inc.
Ophthalmic · 18d
Cleared Mar 31, 1986
MODEL 366-19 ADAPTAID ADAPTER SLEEVE
K860985 · DTB
Intermedics, Inc.
Cardiovascular · 14d
Cleared Mar 31, 1986
MODEL 366-09 ADAPTAID ADAPTER SLEEVE
K860986 · DTB
Intermedics, Inc.
Cardiovascular · 14d
Cleared Mar 31, 1986
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
K861013 · KYG
Ameritek, Inc.
Ophthalmic · 13d
Cleared Mar 28, 1986
HV-4
K853154 · IPF
Robert Bosch Corp.
Physical Medicine · 242d
Cleared Mar 28, 1986
SP 4
K853541
Robert Bosch Corp.
Physical Medicine · 214d
Cleared Mar 28, 1986
MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM
K854386 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 148d
Cleared Mar 28, 1986
MIDIFICATION SYS*STIM 207 (MODEL-ME207)
K855249 · IPF
Mettler Electronics Corp.
Physical Medicine · 92d