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
90241–90264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1998
LATIS GRAFT CLEANING CATHETER
K973465 · DXE
Applied Medical Resources
Cardiovascular · 160d
Cleared Feb 19, 1998
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
K973962 · DSP
C.R. Bard, Inc.
Cardiovascular · 126d
Cleared Feb 19, 1998
VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET
K974215 · LKY
Vetco, Inc.
Gastroenterology & Urology · 101d
Cleared Feb 19, 1998
MLS ELECTROMYOGRAPHIC PREAMPLIFIER
K974385 · IKN
Motion Lab Systems, Inc.
Neurology · 90d
Cleared Feb 19, 1998
KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE...
K974389 · HFN
Clinical Innovations, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 19, 1998
3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT
K974402 · DZE
Vancouver Implant Resources, Inc.
Dental · 90d
Cleared Feb 19, 1998
3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT
K974403 · DZE
Vancouver Implant Resources, Inc.
Dental · 90d
Cleared Feb 19, 1998
4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT
K974404 · DZE
Vancouver Implant Resources, Inc.
Dental · 90d
Cleared Feb 19, 1998
FRIEDL GLIDING NAIL SYSTEM
K974409 · KTT
Plus Orthopedics
Orthopedic · 87d
Cleared Feb 19, 1998
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT...
K974420 · DSH
Hewlett-Packard Co.
Cardiovascular · 87d
Cleared Feb 19, 1998
MICHELSON ANTERIOR CERVICAL PLATE SYSTEM
K974435 · KWQ
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Feb 19, 1998
BOSTON ADVANCE CLEANER
K974466 · MRC
Polymer Technology Corp.
Ophthalmic · 85d
Cleared Feb 19, 1998
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
K974467 · HJO
Aesculap-Meditec North America
Ophthalmic · 85d
Cleared Feb 19, 1998
MOISTAIR FLUID AIR TUBING SET
K974561 · KYG
American Medical Devices, Inc.
Ophthalmic · 76d
Cleared Feb 19, 1998
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
K974684 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 65d
Cleared Feb 19, 1998
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
K974775 · FAP
Airtronic Services, Inc.
Gastroenterology & Urology · 59d
Cleared Feb 19, 1998
RUNCH INDUSTRIAL WHEELCHAIR
K980107 · IOR
Runch Group USA, Inc.
Physical Medicine · 38d
Cleared Feb 18, 1998
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
K971708 · HCC
J & J Engineering, Inc.
Neurology · 286d
Cleared Feb 18, 1998
STELLAR MODEL HS-04
K973223 · IPF
Stellar Medical Corp.
Physical Medicine · 175d
Cleared Feb 18, 1998
BIOROC EZ SUTURE BONE FASTENER
K973381 · MAI
Innovasive Devices, Inc.
Orthopedic · 163d
Cleared Feb 18, 1998
AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
K973760 · DTZ
Avecor Cardiovascular, Inc.
Cardiovascular · 139d
Cleared Feb 18, 1998
INNOVASIVE LINX BT 10MM LIGAMENT FASTENER
K974049 · MBI
Innovasive Devices, Inc.
Orthopedic · 117d
Cleared Feb 18, 1998
JTECH ADJUSTER REFLEX GUN
K974376 · LXM
J-Tech Medical, Inc.
Physical Medicine · 90d
Cleared Feb 18, 1998
ULTRANEB
K974379 · CAF
Bremed Italia, S.R.L.
Anesthesiology · 90d