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
42697–42720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2012
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL...
K122543 · KRD
MicroVention, Inc.
Cardiovascular · 99d
Cleared Nov 28, 2012
BLIP MODEL BP-700WF
K123020 · DXN
Carematix, Inc.
Cardiovascular · 61d
Cleared Nov 28, 2012
SEAL ONE
K123035 · DXC
Perouse Medical
Cardiovascular · 61d
Cleared Nov 28, 2012
CERARESIN BOND
K123119 · KLE
Shofu Dental Corporation
Dental · 56d
Cleared Nov 28, 2012
ILLICO FS FACET FIXATION SYSTEM
K123218 · MRW
Alphatec Spine, Inc.
Orthopedic · 44d
Cleared Nov 28, 2012
AZUR CX DETACHABLE 18
K123384 · KRD
MicroVention, Inc.
Cardiovascular · 26d
Cleared Nov 27, 2012
STABILIZ FIXATION SYSTEM
K120651 · HRS
Stabiliz Orthopaedics, LLC
Orthopedic · 270d
Cleared Nov 27, 2012
MERETE LOCKING BONE PLATE SYSTEM III
K120787 · HRS
Merete Medical GmbH
Orthopedic · 257d
Cleared Nov 27, 2012
WATER BOTTLE CAP IRRIGATON SYSTEM
K120862 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 250d
Cleared Nov 27, 2012
D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000
K121093 · EBZ
Dxm Co., Ltd.
Dental · 231d
Cleared Nov 27, 2012
PICOSURE WORKSTATION
K121346 · GEX
Cynosure, Inc.
General & Plastic Surgery · 207d
Cleared Nov 27, 2012
MULTICROSS SUPPORT CATHETER
K121763 · DQY
Roxwood Medical, Inc.
Cardiovascular · 165d
Cleared Nov 27, 2012
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE +...
K121989 · MQV
Exactech, Inc.
Orthopedic · 144d
Cleared Nov 27, 2012
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
K122561 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 97d
Cleared Nov 27, 2012
TANDA PEARL, ULTRAWYTE, PEARL
K122725 · EEG
Syneron Beauty
Dental · 83d
Cleared Nov 27, 2012
ABBOTT ARCHITECT FREE T4
K123379 · CEC
Abbott Laboratories
Chemistry · 26d
Cleared Nov 26, 2012
KITAZATO OPU NEEDLE
K112462 · MQE
Kitazato Medical Co., Ltd.
Obstetrics & Gynecology · 458d
Cleared Nov 26, 2012
PICCOLO COMPOSITE PLATE SYSTEM
K120409 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 291d
Cleared Nov 26, 2012
POLARIS DIAL-A-DATE CONTACT LENS CASE
K120904 · LRX
Reliance Design & Manufacture Corp.
Ophthalmic · 245d
Cleared Nov 26, 2012
CUROS TIP
K121171 · QBP
Ivera Medical, Inc.
General Hospital · 223d
Cleared Nov 26, 2012
SENSUS ELECTRODE
K121816 · GXY
Neurometrix, Inc.
Neurology · 159d
Cleared Nov 23, 2012
DIOWAVE LOW LEVEL COLD LASER SYSTEM
K121363 · ILY
Technological Medical Advancments,...
Physical Medicine · 200d
Cleared Nov 23, 2012
G7 ACETABULAR SYSTEM
K121874 · PBI
Biomet Manufacturing Corp
Orthopedic · 149d
Cleared Nov 21, 2012
SONICSTIMU COMBO THERAPEUTIC DEVICE
K120217 · IMG
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 302d