Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
41113–41136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2013
TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM...
K122473 · IOQ
Hill-Rom
Physical Medicine · 293d
Cleared Jun 03, 2013
HUMAN CAERULOPLASMIN KIT
K122965 · DDB
The Binding Site Group , Ltd.
Immunology · 252d
Cleared Jun 03, 2013
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · LBH
Bisco, Inc.
Dental · 188d
Cleared Jun 03, 2013
OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
K123885 · PBJ
Osteomed LP
Neurology · 167d
Cleared Jun 03, 2013
VALVED TEARAWAY INTRODUCER GENERATION II
K124046 · DYB
Medical Components, Inc.
Cardiovascular · 154d
Cleared Jun 03, 2013
FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
K130507 · LJS
Footprint Medical, Inc.
General Hospital · 96d
Cleared May 31, 2013
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
K120900 · GGN
Cliniqa Corporation
Hematology · 431d
Cleared May 31, 2013
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
K122700 · LRX
Prosben, Inc.
Ophthalmic · 269d
Cleared May 31, 2013
STRIDE UNICONDYLAR KNEE
K123380 · HSX
Blue Belt Technologies, Inc.
Orthopedic · 211d
Cleared May 31, 2013
INTERLIG
K123823 · EBF
Angelus Industria DE Productos...
Dental · 170d
Cleared May 31, 2013
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
K130129 · KWS
Arthrex, Inc.
Orthopedic · 134d
Cleared May 31, 2013
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K130267 · MNH
Spineart
Orthopedic · 116d
Cleared May 31, 2013
SINGLE ENERGY (SE) FEMUR EXAMS
K130277 · KGI
Hologic, Inc.
Radiology · 116d
Cleared May 31, 2013
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K130293 · LIT
Cook, Inc.
Cardiovascular · 114d
Cleared May 31, 2013
MEDLINE CANNULATED SCREW
K130319 · HWC
Medline Industries, Inc.
Orthopedic · 112d
Cleared May 31, 2013
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
K130332 · CDT
Ortho-Clinical Diagnostics, Inc.
Chemistry · 109d
Cleared May 31, 2013
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
K130338 · OBH
ImpediMed Limited
Gastroenterology & Urology · 109d
Cleared May 31, 2013
OSTEOMED EXTREMIFUSE SYSTEM
K130412 · HWC
Osteomed
Orthopedic · 101d
Cleared May 31, 2013
PHT-6500, PHT-60CFO
K130432 · OAS
VATECH Co., Ltd.
Radiology · 99d
Cleared May 31, 2013
SURGISEAL TOPICAL SKIN ADHESIVE
K130474 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 95d
Cleared May 31, 2013
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
K130498 · MBP
Bacterin International, Inc.
Orthopedic · 94d
Cleared May 31, 2013
ENDOFORM RECONSTRUCTIVE TEMPLATE
K130547 · FTM
Mesynthe, Ltd.
General & Plastic Surgery · 88d
Cleared May 31, 2013
ARS SCREW
K130954 · HWC
Advanced Interventional Technology, LLC
Orthopedic · 56d
Cleared May 31, 2013
PELVIS II IMPLANT SYSTEM
K131132 · HRS
Stryker Trauma AG
Orthopedic · 38d