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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
120385–120408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1991
K-FREE
K912587 · LDD
Katecho, Inc.
Cardiovascular · 48d
Cleared Jul 30, 1991
MECONIUM ASPIRATION
K912596 · BSY
Pacific Device, Inc.
Anesthesiology · 50d
Cleared Jul 30, 1991
REP ALP-15, 8, & 4 KITS
K912603 · CIN
Helena Laboratories
Chemistry · 50d
Cleared Jul 30, 1991
TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
K912725 · JJY
Creative Laboratory Products, Inc.
Chemistry · 40d
Cleared Jul 30, 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 30, 1991
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 30, 1991
BACTI-SWAB(TM) II
K912831 · LIO
Remel Co.
Microbiology · 34d
Cleared Jul 30, 1991
LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY
K912858 · CFL
London Diagnostics, Inc.
Chemistry · 32d
Cleared Jul 30, 1991
SYNERMED SERUM IRON-600 REAGENT KIT
K912912 · CFM
Synermed, Inc.
Chemistry · 27d
Cleared Jul 30, 1991
MILENIA ESTRADIOL
K912917 · CHP
Diagnostic Products Corp.
Chemistry · 27d
Cleared Jul 30, 1991
RHYTHM
K912938 · GWS
Stellate Systems
Neurology · 25d
Cleared Jul 30, 1991
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
K913066 · KLT
Syva Co.
Toxicology · 20d
Cleared Jul 29, 1991
INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE
K903962 · LRP
Apk Technology
General & Plastic Surgery · 335d
Cleared Jul 29, 1991
KITS AND TRAYS FOR ONE TIME USE ONLY
K903963 · LRP
Apk Technology
General & Plastic Surgery · 335d
Cleared Jul 29, 1991
BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200
K911922 · EOQ
Delta Industries, Inc.
Ear, Nose, Throat · 90d
Cleared Jul 26, 1991
ADVANCE SUTURE NONABSORBABLE DACRON SUTURE
K903175 · GAS
Advance Suture, Inc.
General & Plastic Surgery · 373d
Cleared Jul 26, 1991
FORCEPS
K904723 · GEN
Minto Research & Development, Inc.
General & Plastic Surgery · 282d
Cleared Jul 26, 1991
GROSS HIP FEMORAL COMPONENT
K904737 · JDI
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 281d
Cleared Jul 26, 1991
INTAVENT LARYNGEAL MASK
K904834 · CAE
Intavent Intl. S.A.
Anesthesiology · 275d
Cleared Jul 26, 1991
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
K910304 · LQL
Vitek Systems, Inc.
Microbiology · 183d
Cleared Jul 26, 1991
ULTIMATE 3000
K910839 · LNH
Fonar Corp.
Radiology · 149d
Cleared Jul 26, 1991
SYSMEX F-810
K910849 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 149d
Cleared Jul 26, 1991
FINN KNEE PROSTHESIS
K910877 · KRO
Biomet, Inc.
Orthopedic · 147d
Cleared Jul 26, 1991
MASTERPIECES MICRO SYSTEM
K910957 · HRS
Storz Instrument Co.
Orthopedic · 142d