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
77161–77184 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2001
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
K011197 · FTC
Lumenis
General & Plastic Surgery · 239d
Cleared Dec 14, 2001
AIA-PACK CTNI 2ND-GEN ASSAY
K012820 · MMI
Tosoh Medics, Inc.
Chemistry · 113d
Cleared Dec 14, 2001
ORTHOSONIX ENERGEX
K013094 · NHH
Orthosonix, Inc.
Neurology · 88d
Cleared Dec 14, 2001
ASMOTOM AUTOMATED TREPHINE SYSTEM
K013151 · HRG
Bkg Opthalmics USA, Inc.
Ophthalmic · 85d
Cleared Dec 14, 2001
RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01
K013200 · CAH
Rennels Medical Corp.
General Hospital · 80d
Cleared Dec 14, 2001
GORE INTRODUCER SHEATH
K013282 · DBY
W.L. Gore & Associates, Inc.
Immunology · 73d
Cleared Dec 14, 2001
NIPRO HYPODERMIC NEEDLE
K013293 · FMI
Nipro Medical Corp.
General Hospital · 73d
Cleared Dec 14, 2001
CTS-415
K013327 · IYO
Shantou Institute of Ultrasonic...
Radiology · 70d
Cleared Dec 14, 2001
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
K013401 · MQG
K-Systems, Kivex Biotec , Ltd.
Obstetrics & Gynecology · 60d
Cleared Dec 14, 2001
ETHANOL
K013538 · DML
Abbott Laboratories
Toxicology · 51d
Cleared Dec 14, 2001
SHOULDER COIL
K013541 · MOS
Usa Instruments, Inc.
Radiology · 51d
Cleared Dec 14, 2001
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
K013703 · MQG
Sanyo North America Corp.
Obstetrics & Gynecology · 36d
Cleared Dec 14, 2001
MODIFICATION TO:APEX MEDICAL IF-4100
K013813 · GXY
Apex Medical Corp.
Neurology · 28d
Cleared Dec 14, 2001
CONVOY ADVANCED DELIVERY SHEATH KIT
K013866 · DBY
Boston Scientific
Immunology · 23d
Cleared Dec 14, 2001
JOSTRA FLOWPROBE FP-32E
K013939 · DPT
Jostra AG
Cardiovascular · 15d
Cleared Dec 13, 2001
STRESS GUARD, MODEL HERDEV1
K004008 · GZJ
Herbo Medex International, Inc.
Neurology · 352d
Cleared Dec 13, 2001
MODIFICATION TO THE GRIP
K010526 · LIX
Elcare Innovations, Inc.
Cardiovascular · 294d
Cleared Dec 13, 2001
SPINE SCOPE, MODEL 2180
K011454 · HRX
Clarus Medical, LLC
Orthopedic · 216d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · KWS
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Dec 13, 2001
CAIRD TECHNOLOGY HOLTER 2000
K012686 · DPS
Caird Technology
Cardiovascular · 121d
Cleared Dec 13, 2001
WET LIGHT PERSONAL MOISTURIZER
K013086 · HIS
Trigg Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 13, 2001
SOPRO 67D OPERATING ROOM CAMERA
K013090 · GCJ
Sopro
General & Plastic Surgery · 87d
Cleared Dec 13, 2001
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092 · DQX
Guidant Corp.
Cardiovascular · 87d
Cleared Dec 13, 2001
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · FTD
STERIS Corporation
General & Plastic Surgery · 76d