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
118681–118704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1991
GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT
K891411 · JCT
Cook, Inc.
General & Plastic Surgery · 1009d
Cleared Dec 18, 1991
MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
K904556 · IOL
Boston Scientific Corp
Physical Medicine · 439d
Cleared Dec 18, 1991
DUAL FLEX NON-LATEX
K905026 · FGD
Mmi, Inc.
Gastroenterology & Urology · 406d
Cleared Dec 18, 1991
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
K905488 · LMB
Ausonics Pty , Ltd.
Radiology · 376d
Cleared Dec 18, 1991
CONDOMS, MOODS/SHARE & RAKSHAK
K910470 · HIS
Hindustan Latex , Ltd.
Obstetrics & Gynecology · 317d
Cleared Dec 18, 1991
DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX
K910771 · OMB
New England Medical Instruments, Inc.
Neurology · 299d
Cleared Dec 18, 1991
EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE
K911320 · JOP
Applied Biometrics, Inc.
Radiology · 267d
Cleared Dec 18, 1991
URIC ACID (URICASE) REAGENT, UNIVERSAL
K912028 · KNK
Enzyme Technology, Inc.
Chemistry · 224d
Cleared Dec 18, 1991
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
K912498 · HIG
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 196d
Cleared Dec 18, 1991
EAGLE SYSTEM
K912799 · LMC
Marquette Electronics, Inc.
Radiology · 176d
Cleared Dec 18, 1991
PTFE PISTON
K913285 · ETB
River Medical, Inc.
Ear, Nose, Throat · 147d
Cleared Dec 18, 1991
H/A TOTAL-REGULAR, H/A TOTAL-OFFSET
K913286 · ETA
River Medical, Inc.
Ear, Nose, Throat · 147d
Cleared Dec 18, 1991
H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
K913287 · ETB
River Medical, Inc.
Ear, Nose, Throat · 147d
Cleared Dec 18, 1991
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 131d
Cleared Dec 18, 1991
SOFTRANS INJECTOR
K913626 · HQL
Staar Surgical Co.
Ophthalmic · 125d
Cleared Dec 18, 1991
MODIFIED VOLUMETRIC INFUSION PUMP
K913661 · FRN
Mcgaw, Inc.
General Hospital · 138d
Cleared Dec 18, 1991
CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
K913691 · DTR
Gish Biomedical, Inc.
Cardiovascular · 121d
Cleared Dec 18, 1991
TOXOPLASMA IGM ELISA TEST SYSTEM
K913787 · LGD
Zeus Scientific, Inc.
Microbiology · 117d
Cleared Dec 18, 1991
MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS
K913954 · GCJ
Marlo Surgical Technology
General & Plastic Surgery · 104d
Cleared Dec 18, 1991
GAS TRAK CONNECT BLOOD GAS CONTROL
K914099 · JPK
Biochemical Sciences, Inc.
Chemistry · 97d
Cleared Dec 18, 1991
IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE
K914171 · DIH
Tech Intl. Co.
Chemistry · 92d
Cleared Dec 18, 1991
POWER FLOSS AND BRUSH EW 129 & EW 120
K914198 · JEQ
Matsushita Electric Co.
Dental · 90d
Cleared Dec 18, 1991
ANGIOGRAPHIC SOFT TIP CATHETER
K914199 · DQO
E-Z-Em, Inc.
Cardiovascular · 90d
Cleared Dec 18, 1991
MERIT DISPOSAL DEPOT(TM)
K914208 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 90d