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

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176,076 results
57697–57720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2008
TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT
K073495 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 28d
Cleared Jan 09, 2008
MODIFICATION TO VALEO VBR
K073505 · MQP
Amedica Corp.
Orthopedic · 27d
Cleared Jan 09, 2008
HABIB LAPAROSCOPIC HEXABLATE
K073687 · GEI
Emcision , Ltd.
General & Plastic Surgery · 12d
Cleared Jan 08, 2008
N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
K072067 · MSH
Shuenn Bao Shing Corporation
General Hospital · 165d
Cleared Jan 08, 2008
PM-60 PULSE OXIMETER
K072581 · DQA
Shenzhen Mindray Bio-Medical...
Anesthesiology · 117d
Cleared Jan 07, 2008
TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER
K072121 · KWZ
Zimmer, Inc.
Orthopedic · 159d
Cleared Jan 07, 2008
NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS
K072292 · NHJ
Dima Italia Srl
Anesthesiology · 144d
Cleared Jan 07, 2008
RADIANCY MISTRAL DEVICE
K072331 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 140d
Cleared Jan 07, 2008
TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE
K072575 · MBH
Stryker Orthopaedics
Orthopedic · 116d
Cleared Jan 07, 2008
REDLINE ALCOHOL BREATH TESTER
K072953 · DJZ
Redline Products (Pty) , Ltd.
Toxicology · 81d
Cleared Jan 07, 2008
MTA ADVANCED MATERIAL
K073218 · KIF
Dentsply Interntional
Dental · 53d
Cleared Jan 07, 2008
XORANCONNECT
K073306 · LLZ
Xoran Technologies, Inc.
Radiology · 45d
Cleared Jan 07, 2008
THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES
K073481 · MBI
Conmed Linvatec
Orthopedic · 27d
Cleared Jan 07, 2008
BIOFOAM BONE WEDGE
K073535 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 21d
Cleared Jan 04, 2008
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
K070605 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 305d
Cleared Jan 04, 2008
LITHOSKOP
K070665 · LNS
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 298d
Cleared Jan 04, 2008
VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM
K071554 · OBJ
Volcano Corporation
Radiology · 211d
Cleared Jan 04, 2008
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K071736 · LPL
CooperVision, Inc.
Ophthalmic · 192d
Cleared Jan 04, 2008
INSPIRATION
K072590 · CBK
Event Medical, Inc.
Anesthesiology · 112d
Cleared Jan 04, 2008
TXCONTROL
K072615 · BZD
Resmed, Ltd.
Anesthesiology · 109d
Cleared Jan 04, 2008
MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM
K072684 · OCZ
Mondeal North America, Inc.
Gastroenterology & Urology · 105d
Cleared Jan 04, 2008
Y-GLIDE
K072745 · DTL
Thomas Medical Products, Inc.
Cardiovascular · 99d
Cleared Jan 04, 2008
SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
K072913 · NEU
Suros Surgical Systems, Inc. A...
General & Plastic Surgery · 84d
Cleared Jan 04, 2008
PROFLU+ ASSAY
K073029 · OCC
Prodesse, Inc.
Microbiology · 67d