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
79441–79464 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2001
KILEJIAN CIRCUMCISOR
K010867 · HFX
Iris Surgical, LLC
Obstetrics & Gynecology · 42d
Cleared May 03, 2001
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
K010991 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 30d
Cleared May 03, 2001
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
K011157 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 17d
Cleared May 02, 2001
VASCULAR ASSIST
K002186 · DPW
Huntleigh Healthcare, Inc.
Cardiovascular · 286d
Cleared May 02, 2001
MACROPORENS CRANILOC
K002334 · GXR
Macropore Biosurgery, Inc.
Neurology · 274d
Cleared May 02, 2001
SYNETEC
K002817 · DQK
Ela Medical, Inc.
Cardiovascular · 233d
Cleared May 02, 2001
PTA-OS SIZING BALLOON, MODEL 360
K003320 · MJN
NuMED, Inc.
Cardiovascular · 190d
Cleared May 02, 2001
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
K003819 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 142d
Cleared May 02, 2001
GLOBAL BY BLASTOCYST MEDIA
K010183 · MQL
Intl., Inc.
Obstetrics & Gynecology · 103d
Cleared May 02, 2001
SURE CHECK OVULATION PREDICTOR
K010244 · CEP
Chembio Diagnostic Systems, Inc.
Chemistry · 97d
Cleared May 02, 2001
WEISS RETINAL CANNULA
K010305 · HMX
Micron Surgical, Inc.
Ophthalmic · 90d
Cleared May 02, 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · KTW
Synthes (Usa)
Orthopedic · 89d
Cleared May 02, 2001
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K010322 · HSB
Orthodyne, Inc.
Orthopedic · 89d
Cleared May 02, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K010346 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 86d
Cleared May 02, 2001
ECLIPSE 6.5
K010975 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared May 02, 2001
WHITE MTA MATERIAL
K011009 · KIF
Dentsply International
Dental · 28d
Cleared May 02, 2001
BIOUNIVERSAL PDF
K011022 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared May 02, 2001
D.SIGN 96
K011023 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared May 02, 2001
SIII ALARM AMPLIFIER
K011088 · DTQ
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared May 02, 2001
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007,...
K011115 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 20d
Cleared May 02, 2001
RAICHEM CREATININE URINE STANDARD
K011126 · JIT
Hemagen Diagnostics, Inc.
Chemistry · 19d
Cleared May 02, 2001
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
K011162 · DIO
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared May 01, 2001
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED)...
K002718 · LYY
Tillotson Healthcare Corp.
General Hospital · 243d
Cleared May 01, 2001
SPHYGMOCOR MX MODEL SCOR-MX
K002742 · DSK
Pwv Medical Pty, Lt.
Cardiovascular · 242d