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
149953–149976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1985
L100D PATIENT CIRCUIT DUAL LINE
K844290 · BZO
Life Products, Inc.
Anesthesiology · 66d
Cleared Jan 10, 1985
VIVALITH II 301 PULSE GENERATOR
K844334 · DXY
Pacesetter Systems
Cardiovascular · 64d
Cleared Jan 10, 1985
SURE & NATURAL MAXISHIELDS W/SUPERABSORBENT
K844342 · HHD
Personal Products Co.
Obstetrics & Gynecology · 63d
Cleared Jan 10, 1985
MODEL 78210A TELEMETRY TRANSMITTER
K844376 · DRG
Hewlett-Packard Co.
Cardiovascular · 58d
Cleared Jan 10, 1985
ESOPHAGEAL STETHOSCOPE
K844444 · BZW
Medical Parameters, Inc.
Anesthesiology · 55d
Cleared Jan 10, 1985
FUKUDA DENSHI MODEL FCP-220
K844470 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 52d
Cleared Jan 10, 1985
GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR
K844613 · FSM
Packaging Technologies, Inc.
General & Plastic Surgery · 44d
Cleared Jan 10, 1985
GOWNS, SURGICAL
K844703 · FYA
Medicon, Inc.
General Hospital · 38d
Cleared Jan 10, 1985
CAPS (O.R. NURSE, SURGICAL)
K844704 · FYF
Medicon, Inc.
General & Plastic Surgery · 38d
Cleared Jan 10, 1985
SHOE COVERS
K844705 · FXP
Medicon, Inc.
General Hospital · 38d
Cleared Jan 10, 1985
MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN
K844959 · DTB
Medtronic Vascular
Cardiovascular · 20d
Cleared Jan 09, 1985
ULTRASCAN DIGITAL B
K842757 · IYO
CooperVision, Inc.
Radiology · 177d
Cleared Jan 09, 1985
ABSORBENT ENDODONTIC POINT
K843017 · EKN
United Dental Mfg., Inc.
Dental · 162d
Cleared Jan 09, 1985
BIOGLASS OSSICULAR RECONSTRUCTION PROSTH
K843461 · ETA
American Biomaterials Corp.
Ear, Nose, Throat · 126d
Cleared Jan 09, 1985
HEMODIALYSATE SOLUTIONS
K843866 · KPO
Bicarbolyte Corp.
Gastroenterology & Urology · 99d
Cleared Jan 09, 1985
DOPSCAN PLUS DS1060
K843891 · IYO
Carolina Medical Electronics
Radiology · 99d
Cleared Jan 09, 1985
THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM
K844056 · FLL
Sensortek, Inc.
General Hospital · 83d
Cleared Jan 09, 1985
RX CBG
K844122 · EJH
Jeneric Ind.
Dental · 78d
Cleared Jan 09, 1985
RX CBY
K844123 · EJH
Jeneric Ind.
Dental · 78d
Cleared Jan 09, 1985
PIT AND FISSURE SEAANTS
K844308 · EBC
Dentsply Intl.
Dental · 64d
Cleared Jan 09, 1985
TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP
K844340 · LHI
Travenol Laboratories, S.A.
General Hospital · 62d
Cleared Jan 09, 1985
RENAISSANCE BONDING AGENT
K844394 · EJT
Williams Gold Refining Co., Inc.
Dental · 57d
Cleared Jan 09, 1985
RENAISSANCE
K844395 · EJT
Williams Gold Refining Co., Inc.
Dental · 57d
Cleared Jan 09, 1985
ENDONEEDLE
K844619 · FHO
Endotherapeutics
Gastroenterology & Urology · 43d