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
89809–89832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1998
NOVA LITE ENDOMYSIAL
K980312 · DBL
Inova Diagnostics, Inc.
Immunology · 65d
Cleared Apr 02, 1998
IL TEST ANTITHROMBIN
K980499 · JBQ
Instrumentation Laboratory CO
Hematology · 52d
Cleared Apr 02, 1998
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
K980521 · KXT
Bayer Corp.
Toxicology · 64d
Cleared Apr 02, 1998
POWDERED LATEX EXAMINATION GLOVES
K980611 · LYY
Servicom Services Sdn Bhd
General Hospital · 99d
Cleared Apr 02, 1998
NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)
K980729 · LZA
Pt. Eka Wira Asia
General Hospital · 36d
Cleared Apr 02, 1998
B-D E ML PEN
K980755 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 36d
Cleared Apr 02, 1998
TERUMO ALLERGY SYRINGE
K980796 · FMF
Terumo Corp.
General Hospital · 31d
Cleared Apr 02, 1998
NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE)
K980807 · LZA
Pt. Eka Wira Asia
General Hospital · 36d
Cleared Apr 02, 1998
HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM
K980860 · IYO
Atlantis Diagnostics Intl., Inc.
Radiology · 28d
Cleared Apr 02, 1998
QUICKCARD PRO HCG TEST, MODEL 9008
K980896 · JHI
Phamatech
Chemistry · 24d
Cleared Apr 01, 1998
EASYGO ASPIRATOR
K971749 · BTA
Precision Medical, Inc.
General & Plastic Surgery · 324d
Cleared Apr 01, 1998
LEKSELL GAMMAPLAN
K973441 · IWB
Patterson Consulting Group, Inc.
Radiology · 202d
Cleared Apr 01, 1998
BIPORE BALLOON DILATATION CATHETER
K973563 · LIT
Bipore, Inc.
Cardiovascular · 194d
Cleared Apr 01, 1998
ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12
K974002 · DIC
Diagnostic Chemicals , Ltd.
Toxicology · 162d
Cleared Apr 01, 1998
BIOLOG 3000 ELECTROCARDIOGRAPH
K974351 · DPS
Micromedical, Inc.
Cardiovascular · 133d
Cleared Apr 01, 1998
HTL MALE CONDOM
K980019 · HIS
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 89d
Cleared Apr 01, 1998
ENDOBUTTON CONTINUOUS LOOP
K980155 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 75d
Cleared Apr 01, 1998
LIGHTSOURCE OR ILLUMINATOR
K980166 · HET
Cuda Products Co.
Obstetrics & Gynecology · 75d
Cleared Apr 01, 1998
AEROSET SYSTEM
K980367 · CGZ
Abbott Laboratories
Chemistry · 62d
Cleared Apr 01, 1998
SABRE BT BLUNT0TIP SURGICAL TROCAR
K980804 · FBQ
Endoscopic Concepts, Inc.
General & Plastic Surgery · 30d
Cleared Apr 01, 1998
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071,...
K980865 · DKZ
Phamatech
Toxicology · 26d
Cleared Mar 31, 1998
CHASE FEMORAL ACCESS CANNULATION SET
K972993 · DWF
Chase Medical, Inc.
Cardiovascular · 231d
Cleared Mar 31, 1998
CARDIO-PAGER SYSTEM
K973527 · MSX
Data Critical Corp.
Cardiovascular · 194d
Cleared Mar 31, 1998
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
K973684 · HAW
Elekta Instrument AB
Neurology · 186d