FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
123001–123024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1991
GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED
K910108 · JIN
Gds Diagnostics
Chemistry · 53d
Cleared Mar 04, 1991
3M BRAND EAR LOOP FACE MASK, 2000F
K910182 · FXX
3M Company
General Hospital · 48d
Cleared Mar 04, 1991
POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
K910252 · HEE
CooperSurgical, Inc.
Obstetrics & Gynecology · 41d
Cleared Mar 04, 1991
OFLOXACIN, 5 MCG SENSI-DISC
K910506 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Mar 04, 1991
CANDELA DIODE TRABECULOPLASTY LASER DTL
K910612 · HQF
Candela Laser Corp.
Ophthalmic · 20d
Cleared Mar 01, 1991
NEEDLE, DIALYSIS
K902564 · FIE
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 263d
Cleared Mar 01, 1991
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD
K902672 · DTB
Intermedics, Inc.
Cardiovascular · 256d
Cleared Mar 01, 1991
HORIZON 2000 ST ANALYSIS OPTION
K903524 · DPS
Mennen Medical, Inc.
Cardiovascular · 207d
Cleared Mar 01, 1991
MYOTRACK, MODEL HH 515
K904025 · BXN
Myotrack Co.
Anesthesiology · 183d
Cleared Mar 01, 1991
PILLING BRUSH VALVULOTOME
K904507 · DWQ
Pilling Co.
Cardiovascular · 150d
Cleared Mar 01, 1991
MODEL 405
K904606 · DPS
Ivy Biomedical Systems, Inc.
Cardiovascular · 142d
Cleared Mar 01, 1991
TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100
K904748 · DRG
Transtracheal Systems
Cardiovascular · 133d
Cleared Mar 01, 1991
TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200
K904749 · DRQ
Transtracheal Systems
Cardiovascular · 133d
Cleared Mar 01, 1991
NEXUS ACETABULAR CUP
K905408 · JDI
Dow Corning Wright
Orthopedic · 88d
Cleared Mar 01, 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
K905423 · DQX
Cordis Corp.
Cardiovascular · 87d
Cleared Mar 01, 1991
PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
K905530 · BYT
Puritan Bennett Corp.
Anesthesiology · 81d
Cleared Mar 01, 1991
MICRORATE INTELLIGENT PUMP
K905610 · FRN
Kendall Mcgaw Laboratories, Inc.
General Hospital · 80d
Cleared Mar 01, 1991
MICRORATE PLUS INTELLIGENT PUMP
K905611 · FRN
Kendall Mcgaw Laboratories, Inc.
General Hospital · 80d
Cleared Feb 28, 1991
BLOM-SINGER SHOWER GUARD
K904729 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 134d
Cleared Feb 28, 1991
NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS
K905248 · DQK
Advanced Technology Laboratories, Inc.
Cardiovascular · 99d
Cleared Feb 28, 1991
THE EYEGAZE SYSTEM
K905474 · ILQ
Lc Technologies, Inc.
Physical Medicine · 84d
Cleared Feb 28, 1991
ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER
K905535 · ITX
Ge Medical Systems Information...
Radiology · 80d
Cleared Feb 28, 1991
LAP 3501 HIGH FLOW INSUFFLATOR
K905705 · HIF
Circon Acmi
Obstetrics & Gynecology · 66d
Cleared Feb 28, 1991
GYN-1500 HYSTEROSCOPIC INUFFLATOR
K905706 · HIG
Circon Acmi
Obstetrics & Gynecology · 66d