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
56593–56616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2008
FMRI HARDWARE SYSTEM
K080515 · LNH
Nordicneurolab
Radiology · 81d
Cleared May 16, 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT...
K080578 · NBC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 74d
Cleared May 16, 2008
REACTIVE DENTAL IMPLANT SYSTEM
K080713 · DZE
Implant Direct, LLC
Dental · 64d
Cleared May 16, 2008
T34L SYRINGE DRIVER
K080954 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 43d
Cleared May 16, 2008
AMPLATZER TORQVUE EXCHANGE SYSTEM
K080994 · DQY
Aga Medical Corp.
Cardiovascular · 39d
Cleared May 16, 2008
SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
K081110 · IYO
Shantou Institute of Ultrasonic...
Radiology · 28d
Cleared May 16, 2008
AUTO-BAND LIGATOR
K081142 · MND
Scandimed International
Gastroenterology & Urology · 24d
Cleared May 15, 2008
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
K071512 · OTP
Ethicon, Inc.
Obstetrics & Gynecology · 346d
Cleared May 15, 2008
ECHELON TITANIUM HIP SYSTEM
K072817 · LPH
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared May 15, 2008
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K073285 · OVE
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 174d
Cleared May 15, 2008
MODIFICATION TO VIPER SPINE SYSTEM
K073562 · NKB
Depuy Spine, Inc.
Orthopedic · 148d
Cleared May 15, 2008
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
K080227 · MRZ
Roche Diagnostics Corp.
General Hospital · 106d
Cleared May 15, 2008
BIOSYAG MEDICAL SYSTEM
K080374 · GEX
Bios S.R.L.
General & Plastic Surgery · 93d
Cleared May 15, 2008
PLATEAU SPACER SYSTEM
K080411 · MAX
Life Spine
Orthopedic · 90d
Cleared May 15, 2008
COLLAGEN TENDON WRAP
K080452 · FTM
Collagen Matrix, Inc.
General & Plastic Surgery · 86d
Cleared May 15, 2008
MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA
K080582 · KPR
Medicatech USA
Radiology · 73d
Cleared May 15, 2008
EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
K080587 · MRZ
Animas Corp.
General Hospital · 73d
Cleared May 15, 2008
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
K080662 · NDY
Genzyme Corporation
Chemistry · 66d
Cleared May 15, 2008
OSTEOMED MODULAR LOCKING FIXATION SYSTEM
K080694 · JEY
Osteomed LP
Dental · 65d
Cleared May 15, 2008
IB NEURO, VERSION 1.0
K080762 · LNH
Imaging Biometrics, LLC
Radiology · 58d
Cleared May 15, 2008
HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING
K080818 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 52d
Cleared May 15, 2008
PROFEMUR LX 5/8 COATED HIP STEM
K081090 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared May 15, 2008
ZIRDENT CAD/CAM BLOCKS
K081253 · EIH
C5 Medical Werks, Inc.
Dental · 13d
Cleared May 14, 2008
HEARTRAK AF
K071130 · DXH
Universal Medical, Inc.
Cardiovascular · 387d