FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90313–90336 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1998
SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED)
K980941 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 22d
Cleared Apr 02, 1998
LATEX EXAMINATION GLOVE
K974660 · LYY
Ideal Quality Sdn., Bhd.
General Hospital · 108d
Cleared Apr 02, 1998
POWDER-FREE LATEX EXAMINATION GLOVE
K974662 · LYY
Ideal Quality Sdn., Bhd.
General Hospital · 108d
Cleared Apr 02, 1998
PARA-PAK SPINCON
K980077 · LKS
Meridian Diagnostics, Inc.
Microbiology · 84d
Cleared Apr 02, 1998
COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE
K980168 · LLZ
Analogic Corp.
Radiology · 76d
Cleared Apr 02, 1998
TERUMO DISPOSABLE HYPODERMC SYRINGE
K980181 · FMF
Terumo Medical Corp.
General Hospital · 72d
Cleared Apr 02, 1998
SILIMED NASAL RETAINER
K980221 · LYA
Silimed, LLC
Ear, Nose, Throat · 70d
Cleared Apr 02, 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
K980224 · MOQ
Alexander Mfg. Co.
General & Plastic Surgery · 70d
Cleared Apr 02, 1998
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
K980306 · LNH
Elscint, Inc.
Radiology · 65d
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