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
125401–125424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1990
CHALLENGE 7000 POWERED MUSCLE STIMULATOR
K901770 · IPF
Maximum Performance Technologies,...
Physical Medicine · 76d
Cleared Jul 03, 1990
MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY
K901815 · DRE
Pioneering Technologies, Inc.
Cardiovascular · 71d
Cleared Jul 03, 1990
PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP
K901936 · JWH
Orthomet, Inc.
Orthopedic · 64d
Cleared Jul 03, 1990
CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL
K902081 · JBP
Hemotec, Inc.
Hematology · 56d
Cleared Jul 03, 1990
THROMBOPLASTIN WITH CALCIUM
K902096 · GJS
Sigma Chemical Co.
Hematology · 56d
Cleared Jul 03, 1990
MINIX, MINIX ST, NEW IC: L74
K902134 · DXY
Medtronic Vascular
Cardiovascular · 54d
Cleared Jul 03, 1990
ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA
K902210 · GGN
Ortho Diagnostic Systems, Inc.
Hematology · 48d
Cleared Jul 03, 1990
ACCUSCAN MICROBEAD STANDARDS
K902294 · JIW
Sigma Chemical Co.
Hematology · 42d
Cleared Jul 03, 1990
NEW LENGTH SUGITA APPLIERS
K902516 · HIC
Sims Surgical, Inc.
Obstetrics & Gynecology · 26d
Cleared Jul 03, 1990
NEUROSURGICAL HEADFRAME ACCESSORIES
K902517 · GZT
Sims Surgical, Inc.
Neurology · 26d
Cleared Jul 03, 1990
ALADAN TRI-CLEAN 110 POWDERLESS LATEX GLOVE
K902565 · LYY
Aladan Corp.
General Hospital · 22d
Cleared Jul 02, 1990
GESCO DUAL LUMEN PER-Q-CATH-DL
K895942 · FOZ
Gesco Intl., Inc.
General Hospital · 264d
Cleared Jul 02, 1990
HYPERTHERMIA SENSOR ACCESSORIES
K900048 · FLL
Valley Medical Research, Inc.
General Hospital · 180d
Cleared Jul 02, 1990
M1350A FETAL MONITOR (INTRAPARTUM)
K900480 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 151d
Cleared Jul 02, 1990
P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY
K900884 · KGC
Applied Medical Technologies
Gastroenterology & Urology · 126d
Cleared Jul 02, 1990
GASTROINTESTINAL TUBES AND ACCESSORIES
K901023 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 119d
Cleared Jul 02, 1990
I.V. ADMINISTRATION SET CONNECTING DEVICE
K901151 · FPA
Dmd, Div. of Casta Pacific Co.
General Hospital · 112d
Cleared Jul 02, 1990
NEEDLEPOINT GUARD
K901546 · FMF
Needlepoint Guard, Inc.
General Hospital · 90d
Cleared Jul 02, 1990
MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP
K901588 · LZG
Medtronic Minimed
General Hospital · 88d
Cleared Jul 02, 1990
IMEX DOP-TONE II
K901593 · KNG
Imex Medical Systems, Inc.
Obstetrics & Gynecology · 88d
Cleared Jul 02, 1990
MEDILENS(TM) CORNEAL SHIELD
K901880 · MOE
Chiron Ophthalmics
Ophthalmic · 67d
Cleared Jul 02, 1990
DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)
K901956 · LMB
Eigen
Radiology · 62d
Cleared Jul 02, 1990
VITALMIX (SET & BAG)
K902482 · LHI
Pacific Device, Inc.
General Hospital · 28d
Cleared Jul 02, 1990
FLOCARE N
K902501 · BYD
Flocare Medical
Anesthesiology · 27d