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
80425–80448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2001
PECTOFIX STERNAL REPAIR WIRE
K003951 · JDQ
Pectofix, Inc.
Orthopedic · 90d
Cleared Mar 21, 2001
DJ ORTHOPEDICS TIBIAL ANCHOR
K003960 · MBI
Dj Orthopedics, LLC
Orthopedic · 90d
Cleared Mar 21, 2001
AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR
K003971 · MBI
Axya Medical, Inc.
Orthopedic · 89d
Cleared Mar 21, 2001
IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK
K010058 · LLZ
Witt Biomedical Corporation
Radiology · 72d
Cleared Mar 21, 2001
OHMEDA MEDICAL GIRAFFE INCUBATOR
K010222 · FMZ
Ohmeda Medical
General Hospital · 56d
Cleared Mar 21, 2001
KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C
K010686 · DXQ
Golden Horse Medical Equipment (Wuxi)...
Cardiovascular · 13d
Cleared Mar 20, 2001
PM 1800 CONSERVING DEVICE
K001412 · NFB
Precision Medical, Inc.
Anesthesiology · 320d
Cleared Mar 20, 2001
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
K001535 · KWP
Ortho Tec, LLC
Orthopedic · 307d
Cleared Mar 20, 2001
LACTOSORB 5.0 MM WASHER
K001581 · HWC
Biomet, Inc.
Orthopedic · 302d
Cleared Mar 20, 2001
FS ACTIVATOR III
K003185 · LXM
Activator Methods International, Ltd.
Physical Medicine · 160d
Cleared Mar 20, 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · DZE
Institut Straumann AG
Dental · 153d
Cleared Mar 20, 2001
ESCREEN SYSTEM
K003352 · LAF
Escreen, Inc.
Toxicology · 145d
Cleared Mar 20, 2001
APEX MODULAR ZIRCONIA FEMORAL HEAD
K003923 · LZO
Apex Surgical, LLC
Orthopedic · 90d
Cleared Mar 20, 2001
NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
K010031 · KTB
Wescor, Inc.
Physical Medicine · 76d
Cleared Mar 20, 2001
MODIFICATION TO TRIDENT ALL POLY CUP
K010310 · JDI
Howmedica Osteonics Corp.
Orthopedic · 47d
Cleared Mar 20, 2001
ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM
K010482 · JOP
Echocath, Inc.
Cardiovascular · 28d
Cleared Mar 20, 2001
WRISTWATCH BLOOD PRESSURE MONITOR A46
K010498 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 27d
Cleared Mar 20, 2001
PORTRAIT FEMORAL COMPONENT
K010560 · LZO
Biomet, Inc.
Orthopedic · 22d
Cleared Mar 20, 2001
MODIFICATION TO LAP TOP VENTILATOR (LTV)
K010608 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 19d
Cleared Mar 20, 2001
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER
K010640 · DRQ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 15d
Cleared Mar 20, 2001
PLEURX PLEURAL CATHETER AND DRAINAGE KITS
K010642 · DWM
Denver Biomedicals, Inc.
Anesthesiology · 15d
Cleared Mar 20, 2001
EXHALE DOPPLER SYSTEM
K010649 · IYN
Broncus Technologies, Inc.
Radiology · 15d
Cleared Mar 19, 2001
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
K002665 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 206d
Cleared Mar 19, 2001
NEOLYNX SCREENING APPLICATION MANAGER
K003584 · JNB
Micromass, Inc.
Chemistry · 119d