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

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175,820 results
45265–45288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2012
HAPTITE COATING IMPLANT SYSTEM
K111364 · DZE
Dentis Co., Ltd.
Dental · 261d
Cleared Feb 01, 2012
FREEMIE (R)
K111411 · HGX
Dao Health
Obstetrics & Gynecology · 257d
Cleared Feb 01, 2012
SPSMEDICAL SPORVIEW STEAM BI
K111515 · FRC
Spsmedical Supply Corp.
General Hospital · 245d
Cleared Feb 01, 2012
EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
K112074 · ITH
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 196d
Cleared Feb 01, 2012
CONNEXALL SUITE OF SOFTWARE PRODUCTS
K112650 · MSX
Connexall USA, Inc.
Cardiovascular · 142d
Cleared Feb 01, 2012
PASS LP SPINAL
K112736 · JDQ
Medicrea International
Orthopedic · 134d
Cleared Feb 01, 2012
KLASSIC KNEE SYSTEM
K112906 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 121d
Cleared Feb 01, 2012
BIPAP A 30 VENTILATORY SUPPORT SYSTEM
K113053 · MNS
Respironics, Inc.
Anesthesiology · 111d
Cleared Feb 01, 2012
SYNTHES USS CONNECTORS
K113149 · MNI
Synthes Spine
Orthopedic · 100d
Cleared Feb 01, 2012
BRUNO ELAN STAIRWAY ELEVATOR
K113308 · ILK
Bruno Independent Living Aids, Inc.
Physical Medicine · 84d
Cleared Feb 01, 2012
PATIENT MONITOR
K113623 · MHX
Edan Instruments, Inc.
Cardiovascular · 58d
Cleared Feb 01, 2012
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)
K113744 · NEW
Angiotech
General & Plastic Surgery · 43d
Cleared Feb 01, 2012
SAVANNAH TECHNOLOGIES SPINAL SYSTEM
K113755 · MNI
Savannah Technologies, LLC
Orthopedic · 42d
Cleared Jan 31, 2012
UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
K111305 · MQB
Meridian Medical Systems, LLC
Radiology · 267d
Cleared Jan 31, 2012
AUDIT MICROCV T-UPTAKE LINEARITY
K112143 · JJX
Aalto Scientific, Ltd.
Chemistry · 189d
Cleared Jan 31, 2012
TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
K112526 · MBI
Smith & Nephew, Inc.
Orthopedic · 153d
Cleared Jan 31, 2012
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
K113014 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 112d
Cleared Jan 31, 2012
ACTIVECARE DVT ACTIVECARE+SFT
K113525 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 63d
Cleared Jan 31, 2012
TRANSTEK BLOOD PRESSURE MONITOR
K120058 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 22d
Cleared Jan 30, 2012
CLARITY OBP SYSTEM
K111332 · IYE
Elekta , Ltd.
Radiology · 264d
Cleared Jan 30, 2012
DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE
K111385 · LLZ
Qubyx Limited
Radiology · 258d
Cleared Jan 30, 2012
BIOGEL (R) INDICATOR (R) UNDERGLOVE
K111413 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 255d
Cleared Jan 30, 2012
SMART READ EZTEST STEAM
K112018 · FRC
Mesa Laboratories, Inc.
General Hospital · 200d
Cleared Jan 30, 2012
LRT ATTACHMENT
K112333 · NHA
Bcf Certification, Inc.
Dental · 171d