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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
154033–154056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1984
PARAMAX TOTAL PROTEIN REAGENT TP
K845052 · CEK
American Dade
Chemistry · 58d
Cleared Apr 12, 1984
3-DAY BIOINDICATOR RELEASE PROCESS FOR
K833830 · DWF
Shiley, Inc.
Cardiovascular · 157d
Cleared Apr 11, 1984
ANTHRO-MODULAR TOTAL KNEE
K834432 · JWH
Zimmer, Inc.
Orthopedic · 117d
Cleared Apr 11, 1984
META-3
K841506
Whale Scientific, Inc.
Chemistry
Cleared Apr 10, 1984
NORELCO ELECTRONIC DIGITAL BP METER
K841489
North American Philips Corp.
Cardiovascular
Cleared Apr 06, 1984
CONTINUOUS VENTILATOR
K840119 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 86d
Cleared Apr 06, 1984
ABM ANESTHESIA & BRAIN MONITOR
K840232
Datex Division Instrumentarium Corp.
Cardiovascular · 87d
Cleared Apr 06, 1984
SERA-250
K841441
Horiba Instruments, Inc.
Chemistry
Cleared Apr 05, 1984
FLOW-PAC CPK REAGENT SET
K832977 · JHY
American Research Products Co.
Chemistry · 216d
Cleared Apr 05, 1984
CLICK-COUNT U100 INSULIN SYRINGE
K833706 · FMF
Orange Medical Instruments, Inc.
General Hospital · 170d
Cleared Apr 05, 1984
INFANT WARMER
K833802 · FMT
Kinetic Concepts, Inc.
General Hospital · 156d
Cleared Apr 05, 1984
IOCARE IRRIGATION & ASPIRATION PACK
K834340 · HQC
Chiron Vision Corp.
Ophthalmic · 115d
Cleared Apr 05, 1984
ALEXOTEK LINGUAL TUBES
K834446 · DZD
Alexotek Co.
Dental · 111d
Cleared Apr 05, 1984
USCI ENDOPROSTHESIS
K834574 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 98d
Cleared Apr 05, 1984
LASER LENS-VARIOUS MODELS
K834610 · HQF
Meditec of America
Ophthalmic · 106d
Cleared Apr 05, 1984
HYPODERMIC NEEDLES & STYLETS
K840033 · FMI
Microvasive
General Hospital · 91d
Cleared Apr 05, 1984
DENTAL FLOSSING INSTRUMENT
K840093 · JES
Leverette Corp.
Dental · 86d
Cleared Apr 05, 1984
SMI DIGITRON
K840186 · JRC
Scientific Manufacturing Industries
Chemistry · 78d
Cleared Apr 05, 1984
MAX-I-PROBE PERIODONTAL ENDODONTIC PROB
K840237 · EIC
Smith & Nephew, Mpl Division
Dental · 76d
Cleared Apr 05, 1984
ONE-WAY AIR VALVE
K840253 · BYZ
Delta Medical Industries
General Hospital · 73d
Cleared Apr 05, 1984
PERIOGRAF DURAPATITE 40-60 MESH
K840260 · LYC
Sterling Drug, Inc.
Dental · 86d
Cleared Apr 05, 1984
IRRIGATION SYSTEM
K840268 · EXD
Coloplast A/S
Gastroenterology & Urology · 73d
Cleared Apr 05, 1984
CAT. 8 DENTAL DEVICES
K840312 · EMG
Imm Enterprises , Ltd.
Dental · 72d
Cleared Apr 05, 1984
RISTOCETIN COFACTOR ASSAY
K840329 · GGP
Helena Laboratories
Hematology · 71d