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
123145–123168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 24, 1990
HARMONY LINE ALLOYS
K905330 · EJT
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 21, 1990
FEEDING TUBE
K896734 · FPD
Unoplast A/S
Gastroenterology & Urology · 386d
Cleared Dec 21, 1990
WILSON-COOK BALLOON DILATION CATHETERS
K900924 · KNQ
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 297d
Cleared Dec 21, 1990
INDX DIP S TICKS
K901597 · LSQ
Intercare Diagnostics, Inc.
Microbiology · 260d
Cleared Dec 21, 1990
YUEFA DISPOSABLE SYRINGE
K902178 · FMF
Blue & Red Corp.
General Hospital · 220d
Cleared Dec 21, 1990
THE VISONIC DOME(TM)
K902306 · LYL
Vista Vision
Ophthalmic · 213d
Cleared Dec 21, 1990
MAMBA CONDOM (RUBBER LATEX)
K902907 · HIS
Rfsu
Obstetrics & Gynecology · 171d
Cleared Dec 21, 1990
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
K903132 · LJC
Ortho Diagnostic Systems, Inc.
Microbiology · 157d
Cleared Dec 21, 1990
HEARSET TELEPHONE HEARING SYSTEM
K903145 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 156d
Cleared Dec 21, 1990
MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER
K903209 · HES
Adler Instrument Co.
Obstetrics & Gynecology · 154d
Cleared Dec 21, 1990
HIGH RISK
K903559 · LYY
Medical Resources, Ltd.
General Hospital · 135d
Cleared Dec 21, 1990
CHIROFLEX FORCEPS
K903575 · KYB
Chiron Ophthalmics
Ophthalmic · 135d
Cleared Dec 21, 1990
ARIES MELDICAL MODEL 2100HC HANK CRANK
K903925 · KFM
Aries Medical, Inc.
Cardiovascular · 130d
Cleared Dec 21, 1990
SEROFAST
K903958 · GSA
Intl. Mycoplasma/Mdc Assoc.
Microbiology · 115d
Cleared Dec 21, 1990
MICRO-MIST NEBULIZER
K904196 · CAF
Bp , Ltd.
Anesthesiology · 100d
Cleared Dec 21, 1990
SURGICAL TROCAR AND CANNULA
K904379 · HET
Applied Vascular Devices, Inc.
Obstetrics & Gynecology · 87d
Cleared Dec 21, 1990
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED
K904523 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 86d
Cleared Dec 21, 1990
KAPPER
K904527 · EJI
Senair-Mot
Dental · 80d
Cleared Dec 21, 1990
ENEMA BULB
K904534 · FCE
R.A.C., Inc.
Gastroenterology & Urology · 78d
Cleared Dec 21, 1990
BONE STAPLE(S)
K904553 · JDR
Synthes (Usa)
Orthopedic · 77d
Cleared Dec 21, 1990
QAR HANDPIECE
K904671 · EFB
Collagen Corp.
Dental · 70d
Cleared Dec 21, 1990
STERILE SURGICAL GLOVES/DOUBLE GLOVER
K905012 · KGO
American Advisors, Inc.
General Hospital · 45d
Cleared Dec 21, 1990
MICRO-AIRE MODEL NUMBER: MK-426
K905097 · HBE
Micro Surgical Instruments Corp.
Neurology · 38d
Cleared Dec 21, 1990
X-L AND X-LX
K905325 · EJT
Ivoclar North America, Inc.
Dental · 23d