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
78073–78096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2001
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763 · DRT
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Nov 15, 2001
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
K013278 · DEL
Roche Diagnostics Corp.
Chemistry · 45d
Cleared Nov 15, 2001
PASS SPINAL SYSTEM
K013431 · MNI
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Nov 15, 2001
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
K013463 · GEI
Arthrocare Corp.
General & Plastic Surgery · 28d
Cleared Nov 15, 2001
CAPIOX RX HARDSHELL RESERVOIR
K013526 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 23d
Cleared Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
K013544 · DAP
Sigma Diagnostics, Inc.
Hematology · 22d
Cleared Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
K013545 · DAP
Sigma Diagnostics, Inc.
Hematology · 22d
Cleared Nov 15, 2001
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
K013608 · OWB
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Nov 14, 2001
MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
K011536 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 180d
Cleared Nov 14, 2001
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
K012738 · GEY
Depuyacromed
General & Plastic Surgery · 90d
Cleared Nov 14, 2001
CONVERGE ACETABULAR SYSTEM
K012739 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Nov 14, 2001
ICE BATON
K012746 · LKX
Behive, Ltd.
Gastroenterology & Urology · 90d
Cleared Nov 14, 2001
ADC PEDIATRIC
K012750 · MQB
Agfa Corp.
Radiology · 90d
Cleared Nov 14, 2001
HEALOS BONE GRAFT MATERIAL
K012751 · MQV
Orquest, Inc.
Orthopedic · 90d
Cleared Nov 14, 2001
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
K012771 · GCJ
Pajunk GmbH
General & Plastic Surgery · 89d
Cleared Nov 14, 2001
N2000 BASE STATION, N2001 NURSE STATION
K012801 · DXN
Neptec Design Group, Ltd.
Cardiovascular · 85d
Cleared Nov 14, 2001
CAROTID GUIDING SHEATH
K012812 · DYB
Terumo Medical Corp.
Cardiovascular · 84d
Cleared Nov 14, 2001
MODIFICATION TO HANDMASTER
K012823 · GZI
Ness-Neuromuscular Electrical...
Neurology · 90d
Cleared Nov 14, 2001
BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060
K012882 · EBI
Thermoelastic Technologies, Inc.
Dental · 78d
Cleared Nov 14, 2001
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
K013283 · MOB
Immuno Concepts, Inc.
Immunology · 43d
Cleared Nov 14, 2001
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
K013285 · MOB
Immuno Concepts, Inc.
Immunology · 43d
Cleared Nov 14, 2001
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
K013291 · NCS
Advanced Diagnostics, Inc.
Radiology · 43d
Cleared Nov 14, 2001
VISULAS 532S
K013402 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 30d
Cleared Nov 14, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K013403 · MNI
Endius, Inc.
Orthopedic · 30d