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
95281–95304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 1996
RECOVER ADULT VEIN WARMER
K963689 · IMD
Florida Medical Industries, Inc.
Physical Medicine · 87d
Cleared Dec 12, 1996
COURIER BALLOON DILATATION CATHETER
K963691 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Dec 12, 1996
THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
K963728 · ILY
China Chongqing Bashan Instrument...
Physical Medicine · 86d
Cleared Dec 12, 1996
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM...
K963746 · JES
Whitehill Oral Technologies, Inc.
Dental · 86d
Cleared Dec 12, 1996
SHUNT TAP
K963802 · JXG
Integra Neurocare, LLC
Neurology · 80d
Cleared Dec 12, 1996
CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)
K963806 · LJS
Bmw Medical, Inc.
General Hospital · 80d
Cleared Dec 12, 1996
LI'S ITCH STOPPER
K963824 · IRT
Hontech Foundation For Medical...
Physical Medicine · 80d
Cleared Dec 12, 1996
CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
K963839 · GCY
Cordis Corp.
General & Plastic Surgery · 79d
Cleared Dec 12, 1996
MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
K963963 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 71d
Cleared Dec 12, 1996
ULTRADENT UNIVERSAL DENTIN SEALANT
K963979 · LBH
Ultradent Products, Inc.
Dental · 70d
Cleared Dec 12, 1996
INTRAVASCULAR INFUSION DEVICE
K963988 · KRA
Boston Scientific Corp
Cardiovascular · 69d
Cleared Dec 12, 1996
ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR
K964071 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 62d
Cleared Dec 12, 1996
REUSABLE TROCAR WITH SLEEVE (COMMON)
K964123 · GCJ
Pilling Weck Group
General & Plastic Surgery · 58d
Cleared Dec 12, 1996
BRENNEN MEDICAL GLUCAN II WOUND DRESSING
K964241 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 49d
Cleared Dec 12, 1996
SUNGLASSES OR MULTIPLE
K964429 · HQY
Trade Resources , Ltd.
Ophthalmic · 37d
Cleared Dec 12, 1996
DIGIFOCUS ITE
K964683 · ESD
Oticon, Inc.
Ear, Nose, Throat · 20d
Cleared Dec 11, 1996
OES UROLOGY
K950719 · EZO
Olympus America, Inc.
Gastroenterology & Urology · 664d
Cleared Dec 11, 1996
ULE-2, MULE-2, HAND ACCESSORY KIT
K962855 · ISD
Penny and Giles Biometrics , Ltd.
Physical Medicine · 142d
Cleared Dec 11, 1996
CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES
K963159 · DRX
Cmc Sense-It, Inc.
Cardiovascular · 119d
Cleared Dec 11, 1996
700-F SERIES STIMULATION ELECTRODES
K964469 · LDD
Cardiotronics Systems, Inc.
Cardiovascular · 34d
Cleared Dec 10, 1996
EZ STIM
K954505 · KOI
Life-Tech Intl., Inc.
Anesthesiology · 439d
Cleared Dec 10, 1996
THERMOSCAN INSTANT THERMOMETER MODEL IR-6000
K954523 · FLL
Thermoscan, Inc.
General Hospital · 438d
Cleared Dec 10, 1996
MAXISTIM
K955031 · KOI
Life-Tech Intl., Inc.
Anesthesiology · 404d
Cleared Dec 10, 1996
HAEMOCELL SYSTEM 350 OR S350
K960734 · CAC
Haemocell Plc
Anesthesiology · 292d