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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
63553–63576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2006
DART-12
K052705 · IYE
Direx Systems Corp.
Radiology · 146d
Cleared Feb 21, 2006
IMPLANTIUM ABUTMENTS
K052823 · NHA
Dentium, Inc.
Dental · 140d
Cleared Feb 21, 2006
MALE NATURAL RUBBER LATEX CONDOM
K053367 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 78d
Cleared Feb 21, 2006
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
K053374 · LYC
Ossacur AG
Dental · 78d
Cleared Feb 21, 2006
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K053635 · NBW
Bionime Corporation
Chemistry · 54d
Cleared Feb 21, 2006
ACL ELITE
K060162 · JPA
Instrumentation Laboratory CO
Hematology · 29d
Cleared Feb 17, 2006
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
K050086 · FRO
Brennen Medical, Inc.
General & Plastic Surgery · 400d
Cleared Feb 17, 2006
CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
K051175 · HGM
Civent Communications, Ltd.
Obstetrics & Gynecology · 287d
Cleared Feb 17, 2006
ARX SPINAL SYSTEM
K051525 · MQP
Amedica Corp.
Orthopedic · 254d
Cleared Feb 17, 2006
CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES
K051636 · NHA
Altatec GmbH
Dental · 242d
Cleared Feb 17, 2006
AXCEL
K051931 · EBF
Tri Dental Innovators
Dental · 219d
Cleared Feb 17, 2006
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
K052057 · MKJ
Medtronic Emergency Response Systems,...
Cardiovascular · 203d
Cleared Feb 17, 2006
XR-SERIES BI-METRIC FEMORAL COMPONENTS
K052089 · LPH
Biomet Manufacturing, Inc.
Orthopedic · 199d
Cleared Feb 17, 2006
TITAN STEERABLE (PTCA) GUIDEWIRE
K052347 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 172d
Cleared Feb 17, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K052659 · NTE
Ev3, Inc.
Cardiovascular · 143d
Cleared Feb 17, 2006
KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K052676 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 143d
Cleared Feb 17, 2006
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
K052828 · DRS
Hospira, Inc.
Cardiovascular · 135d
Cleared Feb 17, 2006
CXR16
K053148 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 99d
Cleared Feb 17, 2006
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
K053253 · KQO
Hemocue AB
Chemistry · 88d
Cleared Feb 17, 2006
RX EPIDURAL NEEDLE
K053318 · BSP
Epimed International, Inc.
Anesthesiology · 79d
Cleared Feb 17, 2006
K-Y BRAND SENSUAL MIST
K053397 · NUC
Mcneil-Ppc, Inc.
Obstetrics & Gynecology · 73d
Cleared Feb 17, 2006
CEPH, MODEL 4900
K053558 · MUH
Schick Technologies, Inc.
Radiology · 58d
Cleared Feb 17, 2006
NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
K053581 · KWQ
Nuvasive, Inc.
Orthopedic · 56d
Cleared Feb 17, 2006
ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
K060019 · LCX
Artron Laboratories, Inc.
Chemistry · 44d