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
41233–41256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2013
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
K123603 · OXO
Ge Healthcare Surgery GE Oec Medical...
Radiology · 177d
Cleared May 17, 2013
AIO HD OTOSCOPE
K123821 · ERA
Blue Focus
Ear, Nose, Throat · 156d
Cleared May 17, 2013
MECTALIF ANTERIOR
K124034 · OVD
Medacta International
Orthopedic · 140d
Cleared May 17, 2013
THE VAULT SYSTEM
K124051 · LLZ
Somersault Orthopedics, Inc.
Radiology · 137d
Cleared May 17, 2013
BREATHE CPAP SYSTEM
K130037 · BZD
Breathe Technologies, Inc.
Anesthesiology · 130d
Cleared May 17, 2013
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS...
K130105 · HTY
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 122d
Cleared May 17, 2013
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K130377 · MQB
Medicatech USA
Radiology · 92d
Cleared May 17, 2013
NEUROQ 3.6
K130451 · KPS
Syntermed, Inc.
Radiology · 84d
Cleared May 17, 2013
SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
K130533 · HSN
Tornier S.A.S.
Orthopedic · 77d
Cleared May 17, 2013
SOMNODENT HERBST
K130558 · LRK
Somnomed, Inc.
Dental · 74d
Cleared May 17, 2013
XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML
K130647 · ELW
Heraeus Kulzer, LLC
Dental · 67d
Cleared May 17, 2013
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
K130885 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared May 17, 2013
ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
K130922 · OLI
Erchonia Medical, Inc.
General & Plastic Surgery · 44d
Cleared May 16, 2013
PORTABLE X-RAY SYSTEM
K122124 · EHD
Osstem Implant Co., Ltd.
Radiology · 302d
Cleared May 16, 2013
VINTAGE MP PRESS OVER
K122614 · EIH
Shofu Dental Corporation
Dental · 262d
Cleared May 16, 2013
ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
K122644 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 260d
Cleared May 16, 2013
MOBILECT VIEWER
K123082 · LLZ
Nephosity, Inc.
Radiology · 227d
Cleared May 16, 2013
AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
K123400 · BWF
Trudell Medical Intl.
Anesthesiology · 192d
Cleared May 16, 2013
CRYSTALSERT DELIVERY SYSTEM
K123736 · MSS
Bausch & Lomb
Ophthalmic · 162d
Cleared May 16, 2013
FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
K124040 · NBW
Taidoc Technology Corporation
Chemistry · 139d
Cleared May 16, 2013
ELITE-I (BI) DUAL LUMEN CATHETER
K130639 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 66d
Cleared May 16, 2013
GATEWAY ADVANAGE Y-ADAPTER
K130909 · OCX
Boston Scientific Corp
Gastroenterology & Urology · 45d
Cleared May 16, 2013
BRUXZIR SHADED
K130924 · EIH
Prismatik Dentalcraft, Inc.
Dental · 43d
Cleared May 16, 2013
4D VIEW
K131118 · LLZ
Ge Healthcare
Radiology · 24d