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
153193–153216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 05, 1984
CIN-SHEAR
K840352 · HFB
Roland J. Zwick, Inc.
Obstetrics & Gynecology · 70d
Cleared Apr 05, 1984
AIRWAY PRESSURE MONITOR
K840420 · CAP
Respiratory Support Products, Inc.
Anesthesiology · 65d
Cleared Apr 05, 1984
CYSTOTOME, 140-S
K840475 · HNY
Cilco, Inc.
Ophthalmic · 62d
Cleared Apr 05, 1984
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
K840645 · CCL
Gambro, Inc.
Anesthesiology · 50d
Cleared Apr 05, 1984
HARVARD ANTI-REFLUX Y-SET
K840760 · FPA
C.R. Bard, Inc.
General Hospital · 42d
Cleared Apr 05, 1984
DIRECT BILIRUBIN REAGENT
K840777 · CIG
American Dade
Chemistry · 57d