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
42793–42816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2012
NAVIGATION SOFTWARE HIP-UNIVERSAL
K122011 · OLO
Brainlab AG
Orthopedic · 129d
Cleared Nov 15, 2012
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
K122090 · MXC
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 122d
Cleared Nov 15, 2012
NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
K122886 · QSY
Hemostasis, LLC
General & Plastic Surgery · 56d
Cleared Nov 15, 2012
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
K122899 · LJT
C.R. Bard, Inc.
General Hospital · 55d
Cleared Nov 15, 2012
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU
K122904 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 55d
Cleared Nov 15, 2012
MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
K123259 · KNW
Devicor Medical Products, Inc.
Gastroenterology & Urology · 28d
Cleared Nov 14, 2012
KLS MARTIN RECON TALON
K122860 · HRS
KLS-Martin L.P.
Orthopedic · 57d
Cleared Nov 13, 2012
ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
K112830 · DSB
Noninvasive Medical Technologies, Inc.
Cardiovascular · 412d
Cleared Nov 13, 2012
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K120857 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 237d
Cleared Nov 13, 2012
HIGH FLOW INSUFFLANTION UNIT
K122180 · HIF
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 113d
Cleared Nov 13, 2012
VPAP S-A
K122324 · MNS
Resmed, Ltd.
Anesthesiology · 104d
Cleared Nov 13, 2012
VERTIFLEX DIRECT DECOMPRESSION SYSTEM
K122662 · HRX
Vertiflex, Inc.
Orthopedic · 74d
Cleared Nov 13, 2012
PASCAL LASER INDIRECT OPHTHALMOSCOPE
K123056 · HQF
Topcon Medical Laser Systems, Inc....
Ophthalmic · 43d
Cleared Nov 13, 2012
OPTIMA MR 430S
K123068 · LNH
Ge Medical Systems, LLC
Radiology · 43d
Cleared Nov 13, 2012
ENCORE 26 ADVANTAGE KIT
K123214 · MAV
Boston Scientific Corp
Cardiovascular · 29d
Cleared Nov 09, 2012
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
K112091 · MEH
Lima Corporate S.P.A.
Orthopedic · 477d
Cleared Nov 09, 2012
VOLTERA POWERED SUCTION PUMP
K112853 · OMP
Suzric Enterprise Co., Ltd.
General & Plastic Surgery · 407d
Cleared Nov 09, 2012
ALN OPTIONAL VANA CAVA FILTER
K113124 · DTK
Aln Implants Chirurgicaux
Cardiovascular · 385d
Cleared Nov 09, 2012
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K113314 · LFR
Hmd Biomedical, Inc.
Chemistry · 366d
Cleared Nov 09, 2012
PSG-1100 SLEEP DIAGNOSTIC SYSTEM
K120888 · GWQ
Nihon Kohden Corp.
Neurology · 231d
Cleared Nov 09, 2012
MICRO/MINI N-PK(F) BONE ANCHOR
K121354 · MBI
Anulex Technologies, Inc.
Orthopedic · 189d
Cleared Nov 09, 2012
MICRO/MINI N-PK(H) BONE ANCHOR
K121356 · MBI
Anulex Technologies, Inc.
Orthopedic · 189d
Cleared Nov 09, 2012
CRIT-LINE CLIP (CLIC)
K121599 · KOC
Fresenius Medical Care North America
Gastroenterology & Urology · 161d
Cleared Nov 09, 2012
NEWPORT AURA VENTILATOR
K121891 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 133d