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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
145513–145536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1986
BOMED-EEA
K853705 · DRX
Bomed Medical Mfr., Ltd.
Cardiovascular · 131d
Cleared Jan 13, 1986
PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA
K853714 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 130d
Cleared Jan 13, 1986
CUSTOM CORONARY MANIFOLD KITS
K853749 · DTL
Procedure Products, Inc.
Cardiovascular · 126d
Cleared Jan 13, 1986
THE SPORTSTER (ELECTRIFIED WHEELCHAIR)
K853918 · INI
Amigo Sales, Inc.
Physical Medicine · 112d
Cleared Jan 13, 1986
MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
K854059 · JHI
Bioclinical Systems, Inc.
Chemistry · 102d
Cleared Jan 13, 1986
AMENDMENT LIFEPAK 8, NPN 052
K854117 · DRO
Physio-Control Corp.
Cardiovascular · 96d
Cleared Jan 13, 1986
CRUISER
K854164 · ITI
Invacare Corp.
Physical Medicine · 90d
Cleared Jan 13, 1986
DEFIGARD 2000
K854175 · LDD
Odam
Cardiovascular · 90d
Cleared Jan 13, 1986
MEDSURG SELDINGER NEEDLE
K854294 · DRC
Medsurg Industries, Inc.
Cardiovascular · 80d
Cleared Jan 13, 1986
MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016
K854582 · DTB
Medtronic Vascular
Cardiovascular · 59d
Cleared Jan 13, 1986
P.A. MEDICAL VAGINAL IRRIGATION SET #1130
K854595 · HED
Pa Medical Corp.
Obstetrics & Gynecology · 56d
Cleared Jan 13, 1986
TERUMO SENSIBEAD EIA HPRL KIT
K854768 · CFT
Terumo Medical Corp.
Chemistry · 47d
Cleared Jan 13, 1986
RANGE-CHEK
K854789 · JJY
American Monitor Corp.
Chemistry · 45d
Cleared Jan 13, 1986
WHITE CROSS STERILE PAD 4IN. X 4IN.
K854809
American White Cross, Inc.
General & Plastic Surgery · 41d
Cleared Jan 13, 1986
SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33
K854814 · GEI
Birtcher Corp.
General & Plastic Surgery · 41d
Cleared Jan 13, 1986
LEE-BEAD BETA FSH (EIA)
K854837 · CGJ
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Jan 13, 1986
VISION CREATININE
K854846 · CGX
Abbott Laboratories
Chemistry · 40d
Cleared Jan 13, 1986
FALKON STRETCH-STERILE
K854850 · NAD
G.B.F. Industries, Inc.
General & Plastic Surgery · 40d
Cleared Jan 13, 1986
V-TREND OC CPK
K854973 · JJT
V-Tech, Inc.
Chemistry · 33d
Cleared Jan 13, 1986
CANWEST-PREGBLUE
K854989 · JHI
Canwest Medictex, Inc.
Chemistry · 32d
Cleared Jan 13, 1986
TISSUE CULTURE MEDIA
K855085 · KIT
Newport Biosystems, Inc.
Pathology · 24d
Cleared Jan 13, 1986
SUTURE REMOVAL KIT
K855131 · JOK
Dynarex Corp.
General Hospital · 21d
Cleared Jan 13, 1986
CEFACLOR SENSI-DISC
K855135 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Jan 13, 1986
COMFORTEX WHEELCHAIR CUSHION
K855181 · KNN
Comfortex, Inc.
Physical Medicine · 18d