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
55657–55680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
K081789 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 77d
Cleared Sep 10, 2008
EXPEDIUM SPINE SYSTEM
K081898 · NKB
Depuy Spine, Inc.
Orthopedic · 69d
Cleared Sep 10, 2008
ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
K082156 · GCJ
Teleflex Medical
General & Plastic Surgery · 42d
Cleared Sep 10, 2008
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K082273 · KWQ
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Sep 09, 2008
VERSAPOD (TM) INSTRUMENT TRAYS
K071783 · KCT
Containmed, Inc.
General Hospital · 435d
Cleared Sep 09, 2008
CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
K073328 · IZI
Paieon, Inc.
Radiology · 287d
Cleared Sep 09, 2008
AUDICOR, HEMO AMBULATORY MONITOR
K073545 · MWJ
Inovise Medical, Inc.
Cardiovascular · 266d
Cleared Sep 09, 2008
EA STIMULATOR
K080221 · GZJ
Helio Medical Supplies, Inc.
Neurology · 224d
Cleared Sep 09, 2008
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
K080776 · HJO
Us Ophthalmic, LLC
Ophthalmic · 174d
Cleared Sep 09, 2008
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
K081374 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 116d
Cleared Sep 09, 2008
RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L
K081659 · DQA
Masimo Corporation
Anesthesiology · 89d
Cleared Sep 09, 2008
PASCAL SYNTHESIS DELIVERY SYSTEM
K081744 · GEX
Optimedica Corporation
General & Plastic Surgery · 82d
Cleared Sep 09, 2008
UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
K081919 · ITX
Fukuda Denshi Co., Ltd.
Radiology · 64d
Cleared Sep 09, 2008
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
K082146 · LWJ
Aesculap Implant Systems, Inc.
Orthopedic · 41d
Cleared Sep 09, 2008
DIGNITY 100
K082246 · IOR
Dignity Medical Devices, Inc.
Physical Medicine · 32d
Cleared Sep 09, 2008
SURGVIEW INTEGRATED VISUALIZATION SYSTEM
K082293 · HRX
Biovision Technologies, LLC
Orthopedic · 28d
Cleared Sep 09, 2008
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A
K082485 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 12d
Cleared Sep 09, 2008
PACSMATE MMD-3213M MONITOR
K082496 · LLZ
Iei Technology Corp.
Radiology · 11d
Cleared Sep 08, 2008
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
K080116 · DXG
Transonic Systems, Inc.
Cardiovascular · 236d
Cleared Sep 08, 2008
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST...
K081013 · LRG
Siemens Healthcare Diagnostics
Microbiology · 152d
Cleared Sep 08, 2008
COMPUMEDICS NEUVO
K081151 · GWQ
Compumedics USA, Ltd.
Neurology · 138d
Cleared Sep 08, 2008
WEIGAO EMPTY CARTRIDGE SYRINGE
K081241 · FMF
Shandong Weigao Group Medical Polymer...
General Hospital · 130d
Cleared Sep 08, 2008
BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
K081547 · FMF
Bio-Med USA, Inc.
General Hospital · 98d
Cleared Sep 08, 2008
SYNTHES RIB FIXATION SYSTEM
K081623 · HRS
Synthes (Usa)
Orthopedic · 90d