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
98257–98280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1996
LILY MULTICANNULA GUIDE
K954999 · KNW
Lily Imaging Solutions Co.
Gastroenterology & Urology · 155d
Cleared Apr 04, 1996
TIGERSCAN/TIGERVIEW
K955237 · LMB
Tau Corp.
Radiology · 142d
Cleared Apr 04, 1996
FORMULATION PREPARATION DEVICE
K955398 · LHI
B.Braun Medical, Inc.
General Hospital · 132d
Cleared Apr 04, 1996
INNOFLUOR QUINIDINE ASSAY SYSTEM
K955568 · LBZ
Oxis Intl., Inc.
Toxicology · 120d
Cleared Apr 04, 1996
HICHEM GLUCOSE/HK REAGENT KIT
K960084 · CFR
Hi Chem, Inc.
Chemistry · 84d
Cleared Apr 04, 1996
PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR
K960089 · JOJ
Cottrell, Ltd.
General Hospital · 84d
Cleared Apr 04, 1996
CPR HEART PACK
K960209 · GAW
Custom Pack Reliability
General & Plastic Surgery · 79d
Cleared Apr 04, 1996
VIP VICTOR INTERACTIVE PROBE
K960245 · EIX
Pro-Dentec
Dental · 79d
Cleared Apr 04, 1996
TITANIUM UNIVERSAL CLAMP
K960269 · LXT
Synthes (Usa)
Orthopedic · 77d
Cleared Apr 04, 1996
HARMONIE SENSA
K960273 · OMB
Stellate Systems
Neurology · 76d
Cleared Apr 04, 1996
IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
K960280 · FPA
Y
General Hospital · 76d
Cleared Apr 04, 1996
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR
K960410 · ESD
Perfect Ear
Ear, Nose, Throat · 66d
Cleared Apr 04, 1996
COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT
K960413 · GEX
Lumenis, Inc.
General & Plastic Surgery · 66d
Cleared Apr 04, 1996
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K960420 · JTZ
Becton Dickinson Microbiology Systems
Microbiology · 66d
Cleared Apr 04, 1996
18 GAUGE TRU-CUT BIOPSY NEEDLE
K960509 · KNW
Baxter Healthcare Corp
Gastroenterology & Urology · 59d
Cleared Apr 04, 1996
NHMC DRESSING TRAY
K960523 · EFQ
National Healthcare Mfg. Corp.
General & Plastic Surgery · 58d
Cleared Apr 04, 1996
DERMASEAL
K960847 · MGP
Bellingham Medical, Inc.
General & Plastic Surgery · 43d
Cleared Apr 04, 1996
3I OSSEOUS FIXATION SYSTEM(S)
K960914 · JEY
Implant Innovations, Inc.
Dental · 29d
Cleared Apr 03, 1996
BONUTTI ANCHOR
K934183 · MBI
Apogee Medical Products, Inc.
Orthopedic · 951d
Cleared Apr 03, 1996
CANDELA HCS 2000 URETHERAL WARMER CATHETER
K955011 · GEH
Candela Laser Corp.
General & Plastic Surgery · 154d
Cleared Apr 03, 1996
VENOM TIEM REAGENT
K955115 · JCO
Medical Diagnostic Technologies, Inc.
Hematology · 146d
Cleared Apr 03, 1996
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
K955677 · LDJ
Beckman Instruments, Inc.
Toxicology · 110d
Cleared Apr 03, 1996
ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS
K960378 · JJX
Actimed Laboratories, Inc.
Chemistry · 68d
Cleared Apr 03, 1996
THE VIRTUAL M-332
K960500 · EWD
Virtual Corp.
Ear, Nose, Throat · 61d