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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38425–38448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2014
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
K132720 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 166d
Cleared Feb 12, 2014
C-BOX PEEK CERVICAL IBF
K132991 · ODP
Innovasis, Inc.
Orthopedic · 141d
Cleared Feb 12, 2014
SHASER V-MINI 2 HAIR REMOVAL SYSTEM
K133201 · ONF
Shaser, Inc.
General & Plastic Surgery · 118d
Cleared Feb 12, 2014
LIGER MEDICAL ESU-110
K133273 · GEI
Liger Medical, LLC
General & Plastic Surgery · 111d
Cleared Feb 12, 2014
VENA PRO
K133274 · JOW
Innovamed Health, LLC
Cardiovascular · 111d
Cleared Feb 12, 2014
15 FR. TANDEMHEART ARTERIAL CANNULA
K133293 · DWF
Cardiacassist, Inc.
Cardiovascular · 110d
Cleared Feb 12, 2014
HYPERSOUND AUDIO SYSTEM (HSS)
K133352 · EPF
Hypersound Health, Inc.
Ear, Nose, Throat · 104d
Cleared Feb 12, 2014
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
K133476 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 92d
Cleared Feb 12, 2014
MDIXON-QUANT
K133526 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 89d
Cleared Feb 12, 2014
LOGIQ E
K133533 · IYN
Ge Healthcare
Radiology · 86d
Cleared Feb 12, 2014
PHYSIOFLOW Q-LINK
K140102 · DSB
Vasocom, Inc.
Cardiovascular · 28d
Cleared Feb 12, 2014
RESTORELLE Y CONTOUR MESH
K140116 · OTO
Coloplast A/S
Obstetrics & Gynecology · 27d
Cleared Feb 11, 2014
GUAVA II
K122632 · DPS
Cardiocomm Solutions, Inc.
Cardiovascular · 531d
Cleared Feb 11, 2014
CONTROL SEAL
K130485 · EBC
Voco GmbH
Dental · 351d
Cleared Feb 11, 2014
JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
K132472 · GDW
Justright Surgical, LLC
General & Plastic Surgery · 188d
Cleared Feb 11, 2014
EZ-IO INTRAOSSEOUS INFUSION SYSTEM
K132583 · FMI
Vidacare Corporation
General Hospital · 179d
Cleared Feb 11, 2014
SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP,...
K132925 · NKB
Amendia, Inc.
Orthopedic · 146d
Cleared Feb 11, 2014
DANA REUSABLE TEST PACK
K133267 · FRC
Dana Products, Inc.
General Hospital · 110d
Cleared Feb 11, 2014
ADHESE UNIVERSAL
K133318 · KLE
Ivoclar Vivadent, AG
Dental · 106d
Cleared Feb 11, 2014
ENDORINGS
K133359 · FED
Endo-Aid, Inc.
Gastroenterology & Urology · 103d
Cleared Feb 11, 2014
V8 TRANSLUMINAL BAV CATHETER
K133607 · OZT
Intervalve, Inc.
Cardiovascular · 78d
Cleared Feb 11, 2014
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · KWS
Exactech, Inc.
Orthopedic · 32d
Cleared Feb 11, 2014
AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
K140117 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 26d
Cleared Feb 10, 2014
CITRISOL ACID CONCENTRATE
K130511 · KPO
Diasol, Inc.
Gastroenterology & Urology · 348d