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
56665–56688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2008
PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS
K073477 · GEX
Photonova Ofsweden AB
General & Plastic Surgery · 150d
Cleared May 09, 2008
LAURIMED SPINAL INJECTION SYSTEM
K080140 · BSP
Laurimed, LLC
Anesthesiology · 108d
Cleared May 09, 2008
WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
K080177 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 106d
Cleared May 09, 2008
OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
K080187 · GEI
Olsen Medical
General & Plastic Surgery · 105d
Cleared May 09, 2008
PULMODYNE CHF FLOW GENERATOR SYSTEM
K080256 · BYE
Pulmodyne
Anesthesiology · 99d
Cleared May 09, 2008
EVOLUTION ESOPHAGEAL STENT SYSTEM
K080359 · ESW
Cook Ireland, Ltd.
Gastroenterology & Urology · 88d
Cleared May 09, 2008
SHELL CAGE, WAVE CAGE, LOOP CAGE
K080401 · MAX
Advanced Medical Technologies AG
Orthopedic · 85d
Cleared May 09, 2008
METHA SHORT STEM HIP SYSTEM
K080584 · MEH
Aesculap Implant System, Inc.
Orthopedic · 67d
Cleared May 09, 2008
LEICA FL800
K080612 · IZI
Leica Microsystems (Schweiz) AG
Radiology · 66d
Cleared May 09, 2008
CHRYSALIS
K080655 · KPR
Meta Imaging Solutions, LLC
Radiology · 63d
Cleared May 09, 2008
PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
K080674 · MJG
PAJUNK GmbH Medizintechnologie
General & Plastic Surgery · 60d
Cleared May 09, 2008
VERISUITE 1.6, VERISUITE-PARTICLE 1.6
K080742 · IYE
Medcom GmbH
Radiology · 53d
Cleared May 09, 2008
PAGEWRITER CARDIOGRAPH
K080999 · DPS
Philips Medical Systems
Cardiovascular · 31d
Cleared May 09, 2008
SOYALA GEL VENTED
K081014 · BZD
Weinmann Gerate Fur Medizin GmbH +...
Anesthesiology · 30d
Cleared May 09, 2008
4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM...
K081036 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared May 09, 2008
FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
K081067 · JEY
Biomet Microfixation, Inc.
Dental · 24d
Cleared May 09, 2008
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
K081105 · JAK
Ge Healthcare
Radiology · 21d
Cleared May 09, 2008
MAMMOSITE CAVITY EVALUATION DEVICE
K081179 · JAQ
Hologic, Inc.
Radiology · 14d
Cleared May 08, 2008
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K071999 · LYZ
Tangshan Hongyun Plastic Products...
General Hospital · 290d
Cleared May 08, 2008
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K072084 · LYZ
Zibo Hongye Shangqin Plastic Rubbert...
General Hospital · 283d
Cleared May 08, 2008
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
K072251 · LZJ
Merete Medical GmbH
Orthopedic · 269d
Cleared May 08, 2008
DESARA MESH SLING, MODEL CAL-DS01
K072456 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 251d
Cleared May 08, 2008
OLYMPUS ESG-100, MODEL WB991046
K073207 · GEI
Celon AG Medical Instruments
General & Plastic Surgery · 177d
Cleared May 08, 2008
TC MATRIX CLINICAL CHEMISTRY ANALYZER
K073370 · JJE
Teco Diagnostics
Chemistry · 160d