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
95929–95952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1996
DENTAL HANDPIECE AND ACCESSORY
K963664 · EFB
Filmtech, Inc.
Dental · 41d
Cleared Oct 24, 1996
A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
K963684 · LJT
Arrow Intl., Inc.
General Hospital · 73d
Cleared Oct 24, 1996
PACER PLUS SYNTHETIC MEDICAL VINYL PATIENT EXAMINATION GLOVE POWDER FREE
K963710 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 38d
Cleared Oct 24, 1996
ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
K963734 · CGZ
Alko Diagnostic Corp.
Chemistry · 56d
Cleared Oct 23, 1996
USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC
K960056 · DQO
C.R. Bard, Inc.
Cardiovascular · 293d
Cleared Oct 23, 1996
AS/3 LIGHT MONITOR
K961247 · DPS
Datex Division Instrumentarium Corp.
Cardiovascular · 205d
Cleared Oct 23, 1996
OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]
K961844 · HAW
Radionics Software Applications, Inc.
Neurology · 163d
Cleared Oct 23, 1996
PILLAR 4-WHEEL SCOOTER
K961888 · INI
Pillar Technology, Inc.
Physical Medicine · 161d
Cleared Oct 23, 1996
SC, CEMENTLESS HIP SYSTEM
K962034 · LWJ
Artos Medical Products GmbH
Orthopedic · 152d
Cleared Oct 23, 1996
CHROME COBALT BALL HEAD
K962268 · LWJ
Artos Medical Products GmbH
Orthopedic · 132d
Cleared Oct 23, 1996
DPAP STEALTH SLEEPNET MODEL NUMBER 84000
K962713 · BZD
Sleepnet Corporation
Anesthesiology · 103d
Cleared Oct 23, 1996
EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
K962846 · LXT
Biodynamic Technologies, Inc.
Orthopedic · 93d
Cleared Oct 23, 1996
GSP1 - GAS SELECTION PANEL
K962869 · CBF
Reimers Systems, Inc.
Anesthesiology · 92d
Cleared Oct 23, 1996
ODS1 - HOOD DRIVER
K962871 · CBF
Reimers Systems, Inc.
Anesthesiology · 92d
Cleared Oct 23, 1996
SKINNY,FRANSEEN,WESCOTT NEEDLES
K962907 · KNW
Baxter Healthcare Corp
Gastroenterology & Urology · 90d
Cleared Oct 23, 1996
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
K962944 · NFB
Transtracheal Systems
Anesthesiology · 89d
Cleared Oct 23, 1996
CORDIS OPTA PTA BALLOON CATHETER
K962945 · LIT
Cordis Corp.
Cardiovascular · 86d
Cleared Oct 23, 1996
RADIONICS SIPHON LIMITING DEVICE (SLD)
K962990 · JXG
Radionics, Inc.
Neurology · 83d
Cleared Oct 23, 1996
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · LBS
Boehringer Mannheim Corp.
Chemistry · 68d
Cleared Oct 23, 1996
MICROGYN PLUS STIMULATION DEVICE
K963222 · KPI
Hollister, Inc.
Gastroenterology & Urology · 68d
Cleared Oct 23, 1996
WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175
K963227 · GCT
Products For Medicine
Gastroenterology & Urology · 65d
Cleared Oct 23, 1996
STANDARD WHEELCHAIR
K963301 · IOR
L & M Resource Information Service, Inc.
Physical Medicine · 63d
Cleared Oct 23, 1996
SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)
K963772 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 34d
Cleared Oct 22, 1996
ELECTRODE RECORDING CATHETER
K954651 · DRF
Boston Scientific Corp
Cardiovascular · 378d