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

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175,820 results
126001–126024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 02, 1990
GENERAL ELECTRIC AMX 3
K902610 · IZL
Pro-Tronics, Inc.
Radiology · 20d
Cleared Jun 29, 1990
RUBBER CONTRACEPTIVE
K896107 · HIS
Banrub Sdn Bhd
Obstetrics & Gynecology · 249d
Cleared Jun 29, 1990
BIOPSY FORCEPS
K901300 · DWZ
Portlyn Corp.
Cardiovascular · 101d
Cleared Jun 29, 1990
NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.
K901499 · GZB
Neuromed, Inc.
Neurology · 92d
Cleared Jun 29, 1990
ACKRAD MPR DRAINAGE CATHETER SET
K901574 · KNT
Ackrad Laboratories
Gastroenterology & Urology · 87d
Cleared Jun 29, 1990
SULLIVAN VARIABLE STIFFNESS CABLE
K901610 · FDF
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 29, 1990
CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM
K901782 · EBH
Productivity Training Corp.
Dental · 73d
Cleared Jun 29, 1990
ZEPPELIN FORCEPS
K901897 · HCZ
Kirwan Surgical Products, Inc.
Obstetrics & Gynecology · 65d
Cleared Jun 29, 1990
ADD'L USE OF THE KTP/YAG SURGICAL LASER
K902058 · GEX
Laserscope
General & Plastic Surgery · 53d
Cleared Jun 29, 1990
NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM
K902063 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 57d