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
58393–58416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2007
VIS-U-ALL II SELF SEAL POUCH
K070765 · KCT
STERIS Corporation
General Hospital · 206d
Cleared Oct 12, 2007
SOUNMED COLOPOSCOPE COLPO-99/99PLUS
K070845 · HEX
Sounmed, Inc.
Obstetrics & Gynecology · 199d
Cleared Oct 12, 2007
ACID ETCHED LAG SCREWS
K070955 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 190d
Cleared Oct 12, 2007
HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D
K071561 · EFB
Beijing North Pole Dental Handpiece...
Dental · 127d
Cleared Oct 12, 2007
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
K071713 · NDC
Medical Decisions Network
General Hospital · 112d
Cleared Oct 12, 2007
MERCURY SPINAL SYSTEM
K071914 · NKB
Spinal Elements, Inc.
Orthopedic · 93d
Cleared Oct 12, 2007
VACU-MED BLOOD COLLECTION NEEDLES
K071947 · FMI
Shina Corp.
General Hospital · 91d
Cleared Oct 12, 2007
PIONEER LOWTOP SPINAL ROD SYSTEM
K072187 · MNI
Pioneer Surgical Technology
Orthopedic · 67d
Cleared Oct 12, 2007
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K072225 · PNO
Angioscore, Inc.
Cardiovascular · 63d
Cleared Oct 12, 2007
SYNFIX-LR SPACER
K072253 · OVD
Synthes Spine Co.Lp
Orthopedic · 59d
Cleared Oct 12, 2007
P.004 ABUTMENTS
K072679 · NHA
Institut Straumann AG
Dental · 21d
Cleared Oct 12, 2007
ION DENTAL RESIN SYSTEM
K072713 · EBI
Dentsply International, Inc.
Dental · 17d
Cleared Oct 12, 2007
VECTOR VISION HIP
K072716 · HAW
Brainlab AG
Neurology · 30d
Cleared Oct 11, 2007
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR...
K070597 · NSU
Nanosphere, Inc.
Hematology · 223d
Cleared Oct 11, 2007
AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR
K070773 · MBI
Axya Medical, Inc.
Orthopedic · 204d
Cleared Oct 11, 2007
INION BIORESTORE
K070998 · MQV
Inion OY
Orthopedic · 185d
Cleared Oct 11, 2007
VIDAS B.R.A.H.M.S. PCT ASSAY
K071146 · NTM
bioMerieux, Inc.
Microbiology · 170d
Cleared Oct 11, 2007
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
K071934 · JQC
Biomet Manufacturing Corp
Hematology · 90d
Cleared Oct 11, 2007
PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE
K072120 · MAX
Innovative Spinal Technologies, Inc.
Orthopedic · 71d
Cleared Oct 11, 2007
CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE
K072295 · DQA
Oridion Capnography, Inc.
Anesthesiology · 56d
Cleared Oct 11, 2007
WIDE SPACED QUATTRODE LEADS
K072462 · GZB
Advanced Neuromodulation Systems
Neurology · 41d
Cleared Oct 11, 2007
VECTORVISION HIP AND HIP SR
K072573 · HAW
Brainlab AG
Neurology · 29d
Cleared Oct 10, 2007
SKIN CARE LIGHT
K070870 · GEX
Transverse Industries Co.
General & Plastic Surgery · 195d
Cleared Oct 10, 2007
NAVIGATOR APPLICATIONS SUITE
K071097 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 175d