FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94465–94488 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1997
SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE
K952912 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 646d
Cleared Apr 02, 1997
STERITEC DRY HEAT INDICATOR LABEL
K953122 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 637d
Cleared Apr 02, 1997
MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR
K954120 · CCK
Magnetic Resonance Equipment Corp.
Anesthesiology · 579d
Cleared Apr 02, 1997
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260 · HSD
Biomet, Inc.
Orthopedic · 365d
Cleared Apr 02, 1997
IMMULITE RUBELLA IGG
K963613 · LFX
Diagnostic Products Corp.
Microbiology · 204d
Cleared Apr 02, 1997
SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
K963631 · OLZ
Omega Results
Neurology · 203d
Cleared Apr 02, 1997
MICS DEVICE SYSTEM
K963716 · DXC
Percutaneous Technologies, Inc.
Cardiovascular · 198d
Cleared Apr 02, 1997
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
K964038 · KLE
Heraeus Kulzer, Inc.
Dental · 180d
Cleared Apr 02, 1997
PRIMARY IV SET
K964435 · FMG
Icu Medical, Inc.
General Hospital · 148d
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