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
165529–165552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1980
AMPCO SKIN SCRUB TRAY
K802375 · FMC
Associated Medical Products Co.
General Hospital · 10d
Cleared Oct 10, 1980
QUICK PRIME LINES, #'S BPL-12, BPL-48 &
K802378 · DWF
Bentley Laboratories, Inc.
Cardiovascular · 10d
Cleared Oct 06, 1980
HYCEL TRIGYCERIDE II TEST
K802422
Hycel, Inc.
Chemistry
Cleared Oct 03, 1980
DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID
K800954 · HED
The Healthcare Group Laboratories, Inc.
Obstetrics & Gynecology · 163d
Cleared Oct 03, 1980
DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN
K800956 · HED
The Healthcare Group Laboratories, Inc.
Obstetrics & Gynecology · 163d
Cleared Oct 03, 1980
OXFORD HUMAN MILK PASTEURISER
K801246 · HGX
Vickers America Medical Corp.
Obstetrics & Gynecology · 128d
Cleared Oct 03, 1980
F/LS MCA APPLICATION SOFTWARE
K801456 · CFR
Instrumentation Laboratory CO
Immunology · 101d
Cleared Oct 03, 1980
INFANT VENTILATORY MEASUREMENT SYSTEM
K801497 · BZC
Medical Graphics Corp.
Anesthesiology · 99d
Cleared Oct 03, 1980
HESSBURG-BFRRON TREPHINE
K801585 · EMF
Precision Instruments, Inc.
General & Plastic Surgery · 84d
Cleared Oct 03, 1980
POLYETHYLENE FILLED BONE PLATE
K801603 · HRS
Zimmer, Inc.
Orthopedic · 81d
Cleared Oct 03, 1980
SORIN PULSE GENERATOR, MODEL #LIT-214
K801640 · DXY
Bentley Laboratories, Inc.
Cardiovascular · 78d
Cleared Oct 03, 1980
BETA-CAP II
K801679 · FJS
Quinton, Inc.
Gastroenterology & Urology · 73d
Cleared Oct 03, 1980
SONIA-SO NOGRAPH-NUMERICAL ANALYSIS
K801844 · IYO
Cgr Medical Corp.
Radiology · 63d
Cleared Oct 03, 1980
SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO
K801918 · BZC
Pulmonary Testing Systems
Anesthesiology · 53d
Cleared Oct 03, 1980
SYSTEM 88 COMPUTERIZED DIFFUSION ANALY
K801919 · BZC
Pulmonary Testing Systems
Anesthesiology · 53d
Cleared Oct 03, 1980
SYSTEM 80 COMPUTERIZED SPIROMETER
K801920 · BZC
Pulmonary Testing Systems
Anesthesiology · 53d
Cleared Oct 03, 1980
CABANNA TAN SUNLAMP
K801925 · LEJ
The Marketing Exchange, Inc.
Radiology · 52d
Cleared Oct 03, 1980
BCM-302 COLLIMATING CONE & COMPENSATIN
K801949 · JZW
B C Medical , Ltd.
Radiology · 49d
Cleared Oct 03, 1980
BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO
K801950 · KPX
B C Medical , Ltd.
Radiology · 49d
Cleared Oct 03, 1980
U.I. OCTOSON
K802030 · DXK
Ausonics Pty , Ltd.
Cardiovascular · 43d
Cleared Oct 03, 1980
NEWBOURNS INFANT VENTILATOR
K802051 · CBK
Bourns Medical Systems, Inc.
Anesthesiology · 39d
Cleared Oct 03, 1980
SPEMBLY 9000 & 9300
K802063 · GZJ
Spembly Medical , Ltd.
Neurology · 38d
Cleared Oct 03, 1980
BABYBIRD 2 VENTILATOR
K802087 · CBK
Bird Products Corp.
Anesthesiology · 31d
Cleared Oct 03, 1980
EGS #300 BATTERY OPER. PORTA. MUSCLE STI
K802107 · IPF
Electro-Med Health Industries, Inc.
Physical Medicine · 30d