FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
100441–100464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1995
TREBAY SCOPE IRRIGATED CLEARING SLEEVE
K955560 · EOB
Trebay Medical Corp.
Ear, Nose, Throat · 16d
Cleared Dec 22, 1995
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI
K955574 · ESD
Resound Corp.
Ear, Nose, Throat · 15d
Cleared Dec 22, 1995
EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY
K955593 · EMX
Shippert Medical Technologies Corp.
Ear, Nose, Throat · 15d
Cleared Dec 22, 1995
MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K955613 · ETB
Misten Medical Corp.
Ear, Nose, Throat · 11d
Cleared Dec 22, 1995
MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS
K955615 · ETA
Misten Medical Corp.
Ear, Nose, Throat · 11d
Cleared Dec 21, 1995
POLYMEDIC SPINAL NEEDLE AND INTRODUCER
K940061 · BSP
Techniques Medicales DE Navaree
Anesthesiology · 714d
Cleared Dec 21, 1995
OPTUS BRONCHOSCOPES
K945268 · EOQ
Optus, Inc.
Ear, Nose, Throat · 419d
Cleared Dec 21, 1995
ALDERSON BREST DOSIMETRY SYSTEM
K946074 · IYE
Radiology Support Devices, Inc.
Radiology · 387d
Cleared Dec 21, 1995
CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION
K950916 · GKZ
Caltag Laboratories, Inc.
Hematology · 295d
Cleared Dec 21, 1995
CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
K950917 · GKZ
Caltag Laboratories, Inc.
Hematology · 295d
Cleared Dec 21, 1995
CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION
K950918 · GKZ
Caltag Laboratories, Inc.
Hematology · 295d
Cleared Dec 21, 1995
CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION
K951073 · GKZ
Caltag Laboratories, Inc.
Hematology · 288d
Cleared Dec 21, 1995
EXL-15DP & 20-DP LINAC
K952108 · IYE
Mitsubishi Intl. Corp.
Radiology · 230d
Cleared Dec 21, 1995
TARGETT PATCH
K952606 · KGX
Cutting Edge Technologies, Inc.
General & Plastic Surgery · 198d
Cleared Dec 21, 1995
PARAGON IMPLANT SYSTEM
K953101 · DZE
Core-Vent Bio-Engineering, Inc.
Dental · 171d
Cleared Dec 21, 1995
MIT ONE STEP PREGNANCY TEST
K953486 · JHI
3c Diagnostics, Inc.
Chemistry · 149d
Cleared Dec 21, 1995
OTOSCAPE
K953814 · EWO
Soundscape Technologies, Inc.
Ear, Nose, Throat · 129d
Cleared Dec 21, 1995
CORDIS WESTER STAR CATHETER
K954390 · DRF
Cordis Webster, Inc.
Cardiovascular · 93d
Cleared Dec 21, 1995
CARTO SYSTEM
K954395 · DQK
Biosense, Ltd.
Cardiovascular · 92d
Cleared Dec 21, 1995
STERILE ISOTONIC SALINE & STERILE WATER
K954442 · JOL
Medcare Custom Packaging, Inc.
General Hospital · 87d
Cleared Dec 21, 1995
THERMOPLASTIC SHIELD
K954456 · KPY
Medtec, Inc.
Radiology · 87d
Cleared Dec 21, 1995
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES
K954573 · LZA
Tillotson Healthcare Corp.
General Hospital · 80d
Cleared Dec 21, 1995
PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES
K954574 · LZA
Tillotson Healthcare Corp.
General Hospital · 80d
Cleared Dec 21, 1995
ARC SERIES
K954581 · IZI
Continental X-Ray Corp.
Radiology · 80d