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
111913–111936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1993
ANTI-DISCONNECTION MECHANISM
K933781 · CBH
Hammer-Plane, Inc.
Anesthesiology · 49d
Cleared Sep 21, 1993
BIOPRO MODULAR TIBIAL TRAY
K922841 · JWH
Biopro, Inc.
Orthopedic · 466d
Cleared Sep 21, 1993
SELBY INSTRUMENTATION
K924474 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 383d
Cleared Sep 21, 1993
BARD URODYNAMIC CATHETER
K924714 · FEN
C.R. Bard, Inc.
Gastroenterology & Urology · 365d
Cleared Sep 21, 1993
RMHS POROUS DISTAL SLEEVE
K930108 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 253d
Cleared Sep 21, 1993
COBAS CORE FSH EIA
K930304 · CGJ
Roche Diagnostic Systems, Inc.
Chemistry · 243d
Cleared Sep 21, 1993
THE NATURAL-KNEE REVISION
K930554 · JWH
Intermedics Orthopedics
Orthopedic · 230d
Cleared Sep 21, 1993
CEDIA VALPORIC ACID ASSAY
K930734 · LEG
Microgenics Corp.
Toxicology · 222d
Cleared Sep 21, 1993
FENWAL 40 MICRON TRANSFUSION FILTER
K931441 · FPB
Baxter Healthcare Corp
General Hospital · 183d
Cleared Sep 21, 1993
ACE CLINICAL CHEMISTRY SYSTEM
K931786 · JJE
Schiapparelli Biosystems, Inc.
Chemistry · 165d
Cleared Sep 21, 1993
OLYMPUS CREATININE REAGENT
K931939 · CGX
Olympus Corp.
Chemistry · 155d
Cleared Sep 21, 1993
THE SAMUELS RETROGRAD VALVULOTOME
K932009 · MGZ
Vascutech, Inc.
Cardiovascular · 151d
Cleared Sep 21, 1993
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406
K932159 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Sep 21, 1993
AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES
K932178 · JJX
Tosoh Medics, Inc.
Chemistry · 139d
Cleared Sep 21, 1993
G C II AGAR WITH SENSIVITALEX
K932879 · JSO
Becton Dickinson Microbiology Systems
Microbiology · 99d
Cleared Sep 20, 1993
SUNGLASSES
K925428 · HQY
Dallas Handbag Co.
Ophthalmic · 328d
Cleared Sep 20, 1993
COURIER PC
K925864 · LMD
Shoreline Business Consulting
Radiology · 305d
Cleared Sep 20, 1993
NON-PRESCRIPTION SUNGLASSES
K926096 · HQY
Lunettes Bondet
Ophthalmic · 292d
Cleared Sep 20, 1993
SPECTACLE FRAMES
K930435 · HOI
Venis DI A. Vendrame
Ophthalmic · 237d
Cleared Sep 20, 1993
WATER PIK PLUS PLAQUE CONTROL SYSTEM
K931380 · EFS
Teledyne Water Pik
Dental · 186d
Cleared Sep 20, 1993
SUNGLASSES
K931504 · HQY
The B & F System, Inc.
Ophthalmic · 179d
Cleared Sep 20, 1993
YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY
K931717 · EAP
Kaycor Intl., Ltd.
Radiology · 167d
Cleared Sep 20, 1993
SPIRIT SHIELD
K931718 · HQY
Eaton Medical Corp.
Ophthalmic · 167d
Cleared Sep 20, 1993
ORTHODONTIC ELASTOMER
K932319 · ECI
Gac Intl., Inc.
Dental · 132d