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
39529–39552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2013
WTF SECURA SYRINGE AND NEEDLE
K132120 · FMF
Beijing Wantefu Medical Apparatus...
General Hospital · 156d
Cleared Dec 12, 2013
MEDCOMP GEN III POWER INJECTABLE PORT
K132177 · LJT
Medcomp ( Medical Components)
General Hospital · 150d
Cleared Dec 12, 2013
MYOPERFUSION
K132523 · JAK
Toshibamedical Systems Corporation
Radiology · 122d
Cleared Dec 12, 2013
SYNC-RX SYSTEM
K132558 · OWB
Volcano Corporation
Radiology · 119d
Cleared Dec 12, 2013
NEOGEN PSR SYSTEM
K132754 · GEI
Energist, Ltd.
General & Plastic Surgery · 100d
Cleared Dec 12, 2013
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
K132803 · DRG
Medapps Inc., Dba Alere Connect
Cardiovascular · 97d
Cleared Dec 12, 2013
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132862 · NBW
Infopia Co, Ltd.
Chemistry · 91d
Cleared Dec 12, 2013
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS...
K133074 · DSP
Datascope Corp.
Cardiovascular · 73d
Cleared Dec 12, 2013
INQWIRE DIAGNOSTIC GUIDE WIRE
K133230 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 52d
Cleared Dec 12, 2013
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
K133435 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Dec 11, 2013
AVINENT DENTAL IMPLANT SYSTEM
K121873 · DZE
Avinent Implant System S.L.
Dental · 532d
Cleared Dec 11, 2013
POLYSITE IMPLANTABLE INFUSION PORTS
K122834 · LJT
Perouse Medical
General Hospital · 450d
Cleared Dec 11, 2013
RETRIEVAL BAG
K123728 · GCJ
Flexbar Machine Corp.
General & Plastic Surgery · 372d
Cleared Dec 11, 2013
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
K130317 · ODP
Genesys Spine
Orthopedic · 306d
Cleared Dec 11, 2013
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
K130708 · JWH
Smith & Nephew, Inc.
Orthopedic · 271d
Cleared Dec 11, 2013
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
K130758 · LKF
Kronner Prototypes, Inc.
Obstetrics & Gynecology · 266d
Cleared Dec 11, 2013
WOUND MEASURING & MONITORING DEVICE
K131596 · FXN
Woundvision, LLC
General & Plastic Surgery · 191d
Cleared Dec 11, 2013
ME
K131649 · ONF
Syneron Beauty , Ltd.
General & Plastic Surgery · 189d
Cleared Dec 11, 2013
ULTHERA SYSTEM
K132028 · OHV
Ulthera, Inc.
General & Plastic Surgery · 163d
Cleared Dec 11, 2013
SIDEXIS 4
K132773 · LLZ
Sirona Dental Systems GmbH
Radiology · 97d
Cleared Dec 11, 2013
VANGUARD XP KNEE SYSTEM
K132873 · MBH
Biomet, Inc.
Orthopedic · 89d
Cleared Dec 11, 2013
CLYDESDALE SPINAL SYSTEM
K132897 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 86d
Cleared Dec 11, 2013
CERTEX OCT SPINAL IMPLANT SYSTEM
K133094 · KWP
X-Spine Systems, Inc.
Orthopedic · 72d
Cleared Dec 11, 2013
ERBE ESU MODEL VIO DV WITH ACCESSORIES
K133180 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 55d