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
121753–121776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1991
SLEEPAP
K905593 · BZD
Medical Industries America, Inc.
Anesthesiology · 131d
Cleared Apr 23, 1991
GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR
K910817 · LNH
General Electric Co.
Radiology · 56d
Cleared Apr 23, 1991
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T
K911405 · LMD
Eastman Kodak Company
Radiology · 25d
Cleared Apr 23, 1991
LAPAROSCOPIC SUCTION IRRIGATION TUBING SET
K911484 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 19d
Cleared Apr 23, 1991
GRANSTAND
K911608 · IPL
Prime Engineering
Physical Medicine · 13d
Cleared Apr 22, 1991
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
K903948 · DTB
Intermedics, Inc.
Cardiovascular · 238d
Cleared Apr 22, 1991
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · DXK
Hewlett-Packard Co.
Cardiovascular · 181d
Cleared Apr 22, 1991
STYLET TRACHAEL TUBE
K905133 · BSR
Medical Devices, Inc.
Anesthesiology · 158d
Cleared Apr 22, 1991
MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH
K905676 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 125d
Cleared Apr 22, 1991
X-T AIR DRILL
K905800 · ERL
Xomed-Treace, Inc.
Ear, Nose, Throat · 115d
Cleared Apr 22, 1991
I/A HANDPIECE WITH REPLACEABLE TIPS
K910245 · GBX
Surgical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Apr 22, 1991
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
K910291 · DSI
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Apr 22, 1991
PRESSURE MONITORING EXTENSION LINE
K910378 · DQO
Professional Medical Services
Cardiovascular · 83d
Cleared Apr 22, 1991
RESTING EKG ELECTRODE SERIES
K910494 · DRX
Medtronic Andover Medical, Inc.
Cardiovascular · 76d
Cleared Apr 22, 1991
VALLEY FORGE BIPOLAR PEN OR FORCEPS
K910510 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 76d
Cleared Apr 22, 1991
FORTRESS MODEL 760-V 4 WHEEL POWER WHEELCHAIR
K910749 · ITI
Fortress Litestyle
Physical Medicine · 60d
Cleared Apr 22, 1991
FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER
K910751 · INI
Fortress Litestyle
Physical Medicine · 60d
Cleared Apr 22, 1991
FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIR
K910753 · ITI
Fortress Litestyle
Physical Medicine · 60d
Cleared Apr 22, 1991
THE PERCEPTOR(TM) STAND ALONE TRANSDUCER
K910764 · DRS
North American Instrument Corp.
Cardiovascular · 81d
Cleared Apr 22, 1991
TEMPERATURE WELL PROBE, TWP SERIES
K910868 · FLL
Gish Biomedical, Inc.
General Hospital · 52d
Cleared Apr 22, 1991
HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS
K910894 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 49d
Cleared Apr 22, 1991
ANTIMICROBIAL AMPICILLIN
K911185 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 35d
Cleared Apr 22, 1991
ANTIMICROBIAL TOBRAMYCIN
K911304 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 28d
Cleared Apr 22, 1991
ANTIMICROBIAL GENTAMICIN
K911305 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 28d