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
115873–115896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
K922583 · LGC
Baxter Diagnostics, Inc.
Microbiology · 124d
Cleared Sep 28, 1992
ULCER WOUND TRAY
K922828 · KKX
Ulti-Med Intl., Inc.
General Hospital · 108d
Cleared Sep 28, 1992
ULTRALITE X-RAY FILM ILLUMINATOR
K922848 · IXC
A & S Trading Co.
Radiology · 102d
Cleared Sep 28, 1992
ENDOPROBES
K922917 · GEX
Endooptiks, Inc.
General & Plastic Surgery · 103d
Cleared Sep 28, 1992
GAMMA GULTAMYL TRANSFERASE TEST
K922947 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 102d
Cleared Sep 28, 1992
ORTHODONTIC STAINLESS STEEL BRACKET
K923029 · EJF
Gac Intl., Inc.
Dental · 97d
Cleared Sep 28, 1992
DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT
K923071 · ESD
Life-Tech Intl., Inc.
Ear, Nose, Throat · 95d
Cleared Sep 28, 1992
MILES URINE AMYLASE METHOD
K923105 · JFJ
Heraeus Kulzer, Inc.
Chemistry · 101d
Cleared Sep 28, 1992
SLIDEX STAPH-KIT
K923212 · JWX
Biomerieux Vitek, Inc.
Microbiology · 89d
Cleared Sep 28, 1992
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000
K923257 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Sep 28, 1992
BASELINE CALIBRATION VERIFICATION CONTROLS
K923284 · DHB
Hycor Biomedical, Inc.
Immunology · 84d
Cleared Sep 28, 1992
QUANTA LITE ACA SCREEN
K923320 · MID
Inova Diagnostics, Inc.
Immunology · 83d
Cleared Sep 28, 1992
OLYMPUS ALKALINE PHOSPHATASE REAGENT
K923527 · CJE
Olympus Corp.
Chemistry · 74d
Cleared Sep 28, 1992
OLYMPUS IRON REAGENT
K923565 · JIY
Olympus Corp.
Chemistry · 73d
Cleared Sep 28, 1992
PRECISE STREP A
K923673 · GTZ
Becton Dickinson Advanced Diagnostics
Microbiology · 68d
Cleared Sep 28, 1992
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · DQA
Hewlett-Packard Co.
Anesthesiology · 67d
Cleared Sep 28, 1992
SOUNDCHOICE K-AMP
K923735 · ESD
Bausch & Lomb, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 28, 1992
BTE WITH ACCESSORY ATTACHED
K923743 · ESD
Phonak, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 28, 1992
RIONET HB75-AL BTE AID
K923801 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Sep 28, 1992
LAP DISK
K923827 · JTO
Remel Co.
Microbiology · 60d
Cleared Sep 28, 1992
CALCIMOL
K923849 · EJK
Voco GmbH
Dental · 59d
Cleared Sep 25, 1992
MICROPROCESSED CONTROLLED LAPAROFLATOR
K913242 · HIF
Bryan Corp.
Obstetrics & Gynecology · 431d
Cleared Sep 25, 1992
SYSTEM 350
K914053 · CAC
Stryker Corp.
Anesthesiology · 382d
Cleared Sep 25, 1992
PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM
K915622 · JAQ
Nucletron-Oldelft Corp.
Radiology · 284d