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
115993–116016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1992
TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL
K922723 · GTQ
Simplicity Diagnostics, Inc.
Microbiology · 105d
Cleared Sep 18, 1992
QUANTA LITE ENA ELISA
K922829 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SS-A ELISA
K922830 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SM ELISA
K922831 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SS-B ELISA
K922832 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE RNP ELISA
K922833 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
CONDUCER CARDIOPLEGIA SET SITH MP4
K922992 · DWF
3M Health Care, Ltd.
Cardiovascular · 88d
Cleared Sep 18, 1992
MODEL #340 STEALTH-TRODE+LS
K923297 · LDD
Cardiotronics, Inc.
Cardiovascular · 74d
Cleared Sep 18, 1992
CONDUCER HEAT EXCHANGER
K923311 · DTR
3M Health Care, Sarns
Cardiovascular · 73d
Cleared Sep 18, 1992
OLYMPUS LACTATE DEHYDROGENASE REAGENT
K923412 · CFJ
Olympus Corp.
Chemistry · 70d
Cleared Sep 18, 1992
OLYMPUS CREATININE REAGENT
K923526 · CGX
Olympus Corp.
Chemistry · 64d
Cleared Sep 18, 1992
ENOXACIN 10 MCG. SENSI SISC
K923952 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 43d
Cleared Sep 17, 1992
FIRST TOUCH/VILEDON NON-WOVEN FILTER
K915752 · FMZ
First Touch Disposables, Inc.
General Hospital · 269d
Cleared Sep 17, 1992
AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR
K920068 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 254d
Cleared Sep 17, 1992
ENDOTEK ULTRA SYSTEM
K920451 · FAP
Surgitek
Gastroenterology & Urology · 226d
Cleared Sep 17, 1992
AUTOVAC
K921107 · BTA
Life Support Products, Inc.
General & Plastic Surgery · 192d
Cleared Sep 17, 1992
AMBU OXYGEN REGULATOR
K921125 · CAN
Amg, LLC
Anesthesiology · 191d
Cleared Sep 17, 1992
CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER
K921310 · DQO
Cordis Corp.
Cardiovascular · 182d
Cleared Sep 17, 1992
SEAL RING FOR NASAL CPAP
K921499 · BYG
Devilbiss Health Care, Inc.
Anesthesiology · 170d
Cleared Sep 17, 1992
MINIDAM II
K921771 · EIE
Delsan Dental Systems
Dental · 157d
Cleared Sep 17, 1992
ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT
K922557 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 111d
Cleared Sep 17, 1992
BARTELS RUBELLA IGM EIA
K922581 · LFX
Baxter Diagnostics, Inc.
Microbiology · 113d
Cleared Sep 17, 1992
BARTELS RUBELLA IGG EIA
K922586 · LFX
Baxter Diagnostics, Inc.
Microbiology · 113d
Cleared Sep 17, 1992
KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM
K922824 · HSX
Joint Medical Products Corp.
Orthopedic · 98d