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
93961–93984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1997
BECTON DICKINSON BLUNT PLASTIC CANNULA
K964654 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 133d
Cleared Apr 02, 1997
CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)
K964989 · LHI
Critical Device Corp.
General Hospital · 110d
Cleared Apr 02, 1997
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K970029 · HLJ
Keeler Instruments, Inc.
Ophthalmic · 89d
Cleared Apr 02, 1997
FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
K970031 · JWH
Encore Orthopedics, Inc.
Orthopedic · 89d
Cleared Apr 02, 1997
ULTRA-BLEND PLUS
K970113 · EJK
Ultradent Products, Inc.
Dental · 79d
Cleared Apr 02, 1997
ESG-1 ELECTROSONOGRAM (ESG-1)
K970116 · NFQ
Myo-Tronics, Inc.
Dental · 79d
Cleared Apr 02, 1997
STONE DISLODGER, BASKET
K970121 · FGO
Boston Scientific Corp
Gastroenterology & Urology · 78d
Cleared Apr 02, 1997
VISTA ILLUMINATION SYSTEM
K970217 · FFS
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 71d
Cleared Apr 02, 1997
ALEXANDER MANUFACTURING COMPANY
K970271 · FLL
Alexander Mfg. Co.
General Hospital · 69d
Cleared Apr 02, 1997
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
K970308 · FHA
Mentor Urology, Inc.
Gastroenterology & Urology · 65d
Cleared Apr 02, 1997
CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)
K970312 · LPL
Flexlens, Inc.
Ophthalmic · 65d
Cleared Apr 02, 1997
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
K970438 · FPA
Baxter Healthcare Corp
General Hospital · 56d
Cleared Apr 02, 1997
ACCUCURE 1000
K970637 · GEX
Lasermed, Inc.
General & Plastic Surgery · 41d
Cleared Apr 02, 1997
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
K970701 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 35d
Cleared Apr 02, 1997
SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM
K970733 · HTY
Synthes (Usa)
Orthopedic · 33d
Cleared Apr 02, 1997
MAXCESS NEEDLEFREE - Y- SITE (100713)
K970800 · FPA
Solopak Medical Products, Inc.
General Hospital · 29d
Cleared Apr 02, 1997
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
K970830 · JTN
Remel, Inc.
Microbiology · 26d
Cleared Apr 02, 1997
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
K970831 · JTN
Remel, Inc.
Microbiology · 26d
Cleared Apr 02, 1997
INDOLE SWAB
K970833 · JTO
Remel, Inc.
Microbiology · 26d
Cleared Apr 02, 1997
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
K970976 · JJY
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Apr 02, 1997
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2
K970979 · JJY
Chiron Diagnostics Corp.
Chemistry · 16d
Cleared Apr 02, 1997
THE ELECSYS CALCHECK PROGESTERONE
K970984 · JJX
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Apr 01, 1997
APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE
K952683 · LIH
Wholesale Medical Imports, Inc.
Neurology · 659d
Cleared Apr 01, 1997
CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER
K954547 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 550d