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
145321–145344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1986
PROOF ALGINATE IMPRESSION MATERIAL
K854855 · ELW
Sybron Corp.
Dental · 56d
Cleared Jan 30, 1986
H40 BASE METAL ALLOY
K854878 · EJH
Jeneric Ind.
Dental · 55d
Cleared Jan 30, 1986
PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT
K854882 · EBC
Lee Pharmaceuticals
Dental · 55d
Cleared Jan 30, 1986
ECUMOL ULTRAVIOLET FACE TANNING UNITS
K854932 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 51d
Cleared Jan 30, 1986
TIPS AND PADS, CANE,CRUTCH AND WALKER
K854940 · FNJ
Healthtech Industries, Inc.
General Hospital · 51d
Cleared Jan 30, 1986
AUSTENAL DENTAL COMPOSITE RESIN
K854957 · EBD
Austenal Dental, Inc.
Dental · 50d
Cleared Jan 30, 1986
FIBER MESH
K855005 · DZE
Fiber Mesh, Inc.
Dental · 48d
Cleared Jan 30, 1986
CHAMPY BONE PLATES & BONE SCREWS
K855030 · JEY
Advanced Biosearch Assn.
Dental · 45d
Cleared Jan 30, 1986
UNIVERSAL PATIENT CHAIR UNI 2000X
K855063 · JAI
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Jan 30, 1986
SPIROMETER TS-400 SLZ 7547
K855069 · BTY
Teledyne Avionics Div. of Teledyne
Anesthesiology · 43d
Cleared Jan 30, 1986
SPIROMETER MODEL TS-200 SLZ 7541
K855070 · BZC
Teledyne Avionics Div. of Teledyne
Anesthesiology · 43d
Cleared Jan 30, 1986
KRYPTOSOL (SUN LAMP)
K860117 · FTC
Trademark Imports
General & Plastic Surgery · 17d
Cleared Jan 30, 1986
PORTALCAST
K860193 · IXI
Diacor, Inc.
Radiology · 8d
Cleared Jan 30, 1986
TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR
K860203 · IZO
Tingle X-Ray Products, Inc.
Radiology · 8d
Cleared Jan 30, 1986
HEALTHDYNE'S EVENT RECORDER SYSTEM
K860254 · BZQ
Healthdyne, Inc.
Anesthesiology · 6d
Cleared Jan 28, 1986
MEDEX X-RAY TABLE
K854328 · KXJ
Philips Medical Systems (Cleveland),...
Radiology · 92d
Cleared Jan 28, 1986
TRAVELPAK MODEL AC-102
K854509 · CAW
Travomed, Inc.
Anesthesiology · 77d
Cleared Jan 28, 1986
MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
K854615 · LKI
Serono Diagnostics, Inc.
Microbiology · 71d
Cleared Jan 28, 1986
DSL ANDROSTENEDIONE RIA (DSL #4200)
K854675 · JLS
Diagnostic Systems Laboratories, Inc.
Chemistry · 68d
Cleared Jan 28, 1986
ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM
K854805 · CFT
Nichols Institute Diagnostics
Chemistry · 57d
Cleared Jan 28, 1986
CIRRUS NEBULIZER-DELUXE KIT
K854952 · CCQ
Dhd Medical Products Div. Diemolding...
Anesthesiology · 49d
Cleared Jan 28, 1986
HCG RIA TEST SYSTEM
K854958 · JHI
Monobind
Chemistry · 48d
Cleared Jan 28, 1986
TOTAL CHOLESTEROL REAGENT SET
K855028 · CHH
Sterling Diagnostics, Inc.
Chemistry · 43d
Cleared Jan 27, 1986
FORTEC MI-305 & 306 DIGITAL THERMOMETER
K853317 · FLL
Nam Tai , Ltd.
General Hospital · 173d