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
145201–145224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1986
SHILEY VENOUS RESERVOIR
K854841 · DTN
Shiley, Inc.
Cardiovascular · 68d
Cleared Feb 10, 1986
MA-1 VOLUME VENTIALTOR
K854843
Puritan Bennett Corp.
Cardiovascular · 68d
Cleared Feb 10, 1986
CURITY URETERAL STENT
K854862 · FAD
The Kendal Co.
Gastroenterology & Urology · 67d
Cleared Feb 10, 1986
DISPOSABLE MANIFOLD
K854960 · DTL
Utah Medical Products, Inc.
Cardiovascular · 61d
Cleared Feb 10, 1986
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
K855003 · KNW
Travenol Laboratories, S.A.
Gastroenterology & Urology · 59d
Cleared Feb 10, 1986
HYDRAJUST III UROLOGICAL TABLE
K860040 · KQS
Mallinckrodt Group, Inc.
Gastroenterology & Urology · 35d
Cleared Feb 10, 1986
URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE
K860143 · JJP
Reagent Laboratory, Inc.
Chemistry · 26d
Cleared Feb 07, 1986
VITREONIC PLUS
K834160 · HQE
American Surgical Co., Inc.
Ophthalmic · 847d
Cleared Feb 07, 1986
VIT PAC
K834162 · HQE
American Surgical Co., Inc.
Ophthalmic · 847d
Cleared Feb 07, 1986
VISITHERM
K852950 · IYM
C.D. Regelin & Associates, Inc.
Radiology · 211d
Cleared Feb 07, 1986
CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS
K853420 · OLT
Alvar
Neurology · 177d
Cleared Feb 07, 1986
5.0 IOP & 7.5 IOP PROBES
K853432 · GXW
Diasonics, Inc.
Neurology · 176d
Cleared Feb 07, 1986
CODMAN LASER BACKSTOP
K853626 · GEX
Codman & Shurtleff, Inc.
General & Plastic Surgery · 162d
Cleared Feb 07, 1986
CODMAN LASER RODS
K853627 · GEX
Codman & Shurtleff, Inc.
General & Plastic Surgery · 162d
Cleared Feb 07, 1986
KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE)
K853727 · LRX
Ryder Intl. Corp.
Ophthalmic · 154d
Cleared Feb 07, 1986
PRECIOUS LITE MODEL 4224
K854122 · LBI
E & B Technologies, Inc.
General Hospital · 121d
Cleared Feb 07, 1986
FIBEROPTIC COLLIMATING HANDPIECE
K854134 · GEX
Dawn Laser Technology, Inc.
General & Plastic Surgery · 120d
Cleared Feb 07, 1986
MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM
K854387 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 99d
Cleared Feb 07, 1986
MODEL CO2 LASER SYSTEM 8B
K854398 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 99d
Cleared Feb 07, 1986
MODEL 20-B CO2 LASER SYSTEM
K854399 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 99d
Cleared Feb 07, 1986
ACUSON NEEDLE GUIDE SYSTEM
K854429 · ITX
Acuson Computed Sonography
Radiology · 94d
Cleared Feb 07, 1986
PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI
K854470 · HHR
Minnesota Laser Corp.
Obstetrics & Gynecology · 93d
Cleared Feb 07, 1986
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA
K854506 · HMX
Storz Instrument Co.
Ophthalmic · 87d
Cleared Feb 07, 1986
STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
K854507 · LXP
Storz Instrument Co.
Ophthalmic · 87d