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
128737–128760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1989
STERILE SURGICAL GOWN
K895667 · FYE
Clinitech, Inc.
General & Plastic Surgery · 23d
Cleared Oct 13, 1989
HANAULUX(R) 2000
K895715 · FTD
W.C. Heraeus GmbH
General & Plastic Surgery · 18d
Cleared Oct 13, 1989
CITREX LATEX EXAMINATION GLOVES
K895722 · LYY
Pt Citra Latex Lestari
General Hospital · 18d
Cleared Oct 13, 1989
MICROMEDICS SURGICAL DRILL SYSTEM
K895739 · HBB
Micromedics, Inc.
Neurology · 17d
Cleared Oct 13, 1989
LATEX PATIENT EXAMINATION GLOVES
K895743 · LYY
Rubbertech Industry Co., Ltd.
General Hospital · 17d
Cleared Oct 12, 1989
ULTRANS DISPOSABLE INTRAUTERINE
K882224 · HFN
Telos Medical Corp.
Obstetrics & Gynecology · 504d
Cleared Oct 12, 1989
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
K890993 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 227d
Cleared Oct 12, 1989
FEM-FLEX FEMORAL ACCESS CANNULATION SET
K891576 · DWF
Research Medical, Inc.
Cardiovascular · 206d
Cleared Oct 12, 1989
PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
K891786 · DWP
Pioneering Technologies, Inc.
Cardiovascular · 202d
Cleared Oct 12, 1989
AMPLAID A308 CLINICAL AUDIOMETER
K891988 · EWO
Amplus Corp.
Ear, Nose, Throat · 198d
Cleared Oct 12, 1989
TENZCARE STIMULATOR 6890
K891992 · GZJ
3M Company
Neurology · 198d
Cleared Oct 12, 1989
COUPLANT WARMING DEVICE
K893225 · IYO
Echo Ultrasound
Radiology · 168d
Cleared Oct 12, 1989
KORN MANDIBULAR ADVANCER
K893482 · EJF
American Orthodontics
Dental · 161d
Cleared Oct 12, 1989
HEMO-ALERT
K893830 · DQO
Koregon Enterprise, Inc.
Cardiovascular · 141d
Cleared Oct 12, 1989
P POLYMER
K893990 · LDD
Pace West
Cardiovascular · 129d
Cleared Oct 12, 1989
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K894286 · DXO
Ppg Industries, Inc.
Cardiovascular · 111d
Cleared Oct 12, 1989
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K894318 · DQX
Datascope Corp.
Cardiovascular · 90d
Cleared Oct 12, 1989
APDYNE PHENOL APPLICATOR KIT
K894369 · KCJ
Apdyne Medical Co.
Ear, Nose, Throat · 90d
Cleared Oct 12, 1989
CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
K894389 · GGX
Catachem, Inc.
Chemistry · 87d
Cleared Oct 12, 1989
CARE DISP. DIAG. ELECTRODES, SILVER/SILVER
K894462 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 86d
Cleared Oct 12, 1989
CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION
K894476 · CJY
Catachem, Inc.
Chemistry · 86d
Cleared Oct 12, 1989
OLYMPUS VALVULOTOME W/FIXED TIP
K894496 · DWX
Olympus Corp.
Cardiovascular · 85d
Cleared Oct 12, 1989
TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000
K894540 · DXH
Physio-Control Corp.
Cardiovascular · 84d
Cleared Oct 12, 1989
CLEARPLAN EASY
K894579 · CEP
Unipath , Ltd.
Chemistry · 80d