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
78217–78240 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2001
AA-1 SYSTEM
K012530 · HJT
Neurovision, Inc.
Ophthalmic · 25d
Cleared Aug 31, 2001
EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
K012663 · IZL
Sedecal USA, Inc.
Radiology · 18d
Cleared Aug 30, 2001
JET THERAPY
K002908 · ISA
Jet Therapy
Physical Medicine · 346d
Cleared Aug 30, 2001
SENSI-PREMA NEONATAL ECG ELECTRODES,...
K003804 · DRX
Niko Medical Products
Cardiovascular · 265d
Cleared Aug 30, 2001
EXEL I.V. ADMINISTRATION SET
K010404 · FPA
Exelint Intl. Co.
General Hospital · 199d
Cleared Aug 30, 2001
VECTORVISION CT/FLUORO
K010968 · HAW
Brainlab AG
Neurology · 150d
Cleared Aug 30, 2001
THE UNI-CLIP STAPLE
K011716 · JDR
New Deal, S.A.
Orthopedic · 87d
Cleared Aug 30, 2001
ATRICURE BIPOLAR COAGULATION SYSTEM
K011722 · GEI
AtriCure, Inc.
General & Plastic Surgery · 87d
Cleared Aug 30, 2001
SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
K011729 · DTC
Dni Nevada, Inc.
Cardiovascular · 87d
Cleared Aug 30, 2001
HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
K011745 · ITI
Transworld Mobility Distribution, LLC
Physical Medicine · 85d
Cleared Aug 30, 2001
PALOMAR LC 100 DIODE LASER
K011747 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 86d
Cleared Aug 30, 2001
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
K011769 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 84d
Cleared Aug 30, 2001
MICRO TARGETING DRIVE SYSTEM
K011775 · HAW
FHC, Inc.
Neurology · 84d
Cleared Aug 30, 2001
INSIGHT GENESIS
K011983 · HCC
Fasstech
Neurology · 65d
Cleared Aug 30, 2001
ILT SUPPORT CATHETER .014, MODEL C114LW1
K012169 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 49d
Cleared Aug 30, 2001
SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM
K012253 · IYO
Aloka Co., Ltd.
Radiology · 43d
Cleared Aug 30, 2001
OPTIBOND 2
K012322 · KLE
Sybron Dental Specialties, Inc.
Dental · 38d
Cleared Aug 30, 2001
TRANSLUX ENERGY
K012341 · EBZ
Heraeus Kulzer, Inc.
Dental · 37d
Cleared Aug 30, 2001
MODIFICATION TO:ENDIUS BIPOLAR SHEATH
K012488 · GEI
Endius, Inc.
General & Plastic Surgery · 27d
Cleared Aug 30, 2001
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH...
K012489 · DYB
Appriva Medical, Inc.
Cardiovascular · 27d
Cleared Aug 30, 2001
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY...
K012507 · LPH
Implex Corp.
Orthopedic · 24d
Cleared Aug 30, 2001
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY...
K012593 · LBR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 20d
Cleared Aug 30, 2001
LIQUISPX LIQUID LIPID CONTROL
K012855 · JJY
Clinical Controls Division
Chemistry · 6d
Cleared Aug 29, 2001
VULCAN TAC PROBES, MODEL 911XXX
K003198 · HRX
Oratec Interventions, Inc.
Orthopedic · 321d