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
148369–148392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1985
MANAN GREENE NEEDLE
K851835 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 19d
Cleared May 17, 1985
MOLIFT
K851844 · FSA
Madshus A/S
General Hospital · 21d
Cleared May 17, 1985
BANE CURVED RONGEUR, 7 SS TYPE 420
K851882
The Huxley Instrument Corp.
General & Plastic Surgery · 18d
Cleared May 17, 1985
Y CONNECTOR
K851921 · GCD
Sil-Med Corp.
General & Plastic Surgery · 15d
Cleared May 17, 1985
HAWKIN NEEDLE
K851953 · GAA
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 14d
Cleared May 17, 1985
CHIBA NEEDLE
K851957 · GAA
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 14d
Cleared May 16, 1985
SYNKARA
K840445 · DRX
Lectec Corp.
Cardiovascular · 472d
Cleared May 16, 1985
RECOMED BLOOD-FLOW METER H236-052-02
K840522 · DPW
Litton Medical Electronics
Cardiovascular · 464d
Cleared May 16, 1985
MODEL T 101 CLINICAL TRANSMITTER
K842435 · DXH
Biometric Products, Inc.
Cardiovascular · 330d
Cleared May 16, 1985
SYSTEM 930 ARGON PHOTOCOAGULATOR
K844356 · HQB
Coherent Medical Group
Ophthalmic · 188d
Cleared May 16, 1985
KONTRON SUPERMON 7210 PATIENT MONITOR
K844731 · DRT
Kontron Instruments, Inc.
Cardiovascular · 163d
Cleared May 16, 1985
OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS
K844800 · DQO
Vas-Cath of Canada , Ltd.
Cardiovascular · 156d
Cleared May 16, 1985
DESERET INTRODUCER SET
K844840 · DYB
Parke-Davis Co.
Cardiovascular · 155d
Cleared May 16, 1985
ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
K844972 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 143d
Cleared May 16, 1985
MEDWATCH 400 CARDIAC CENTRAL NURSES STATION
K850135 · DRT
Medwatch Systems, Inc.
Cardiovascular · 122d
Cleared May 16, 1985
RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH
K850322 · DPS
Eaton Medical Group
Cardiovascular · 108d
Cleared May 16, 1985
TELEMETRY SOFTWARE FOR G-2000 ELECTROCARDIOGRAPH
K850323 · DPS
Eaton Medical Group
Cardiovascular · 108d
Cleared May 16, 1985
GAMBRO PLASMAFILTRATION SYSTEM
K850621 · LKN
Gambro, Inc.
Gastroenterology & Urology · 90d
Cleared May 16, 1985
WSP CODE 4301 DIOMASTER THERAPEUTIC
K850695 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 84d
Cleared May 16, 1985
ACCUTRACKER HEART-RATE MONITOR
K850867 · DXN
Eutectic Electronics, Inc.
Cardiovascular · 76d
Cleared May 16, 1985
ACTION-WHEELS & PLAY WHEELS
K850875
Ketronic, Inc.
Physical Medicine · 76d
Cleared May 16, 1985
LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR
K850876 · ITI
Ketronic, Inc.
Physical Medicine · 76d
Cleared May 16, 1985
BP/CLINIC SYS MEASUREMENT, BP NON-INVASIVE
K850893 · DXN
Sun Dance Technology, Inc.
Cardiovascular · 73d
Cleared May 16, 1985
CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX
K851004 · DTP
Gish Biomedical, Inc.
Cardiovascular · 65d