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
81625–81648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2000
VIPON TAMPON
K992493 · HEB
Another Way Products, LLC
Obstetrics & Gynecology · 469d
Cleared Nov 03, 2000
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
K001044 · MNH
Acme Spine, LLC
Orthopedic · 217d
Cleared Nov 03, 2000
CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40,...
K001213 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 203d
Cleared Nov 03, 2000
MERIDIAN-II AND MERDIAN-PLUS
K001347 · GZO
Meridian Co., Ltd.
Neurology · 189d
Cleared Nov 03, 2000
MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
K001714 · NHK
Mercury Medical
Anesthesiology · 151d
Cleared Nov 03, 2000
ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200
K001788 · DQD
Erecords Enterprises
Cardiovascular · 143d
Cleared Nov 03, 2000
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND...
K002398 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 03, 2000
CANDELA MID IR DIODE LASER SYSTEM
K002421 · GEX
Candela Corp.
General & Plastic Surgery · 87d
Cleared Nov 03, 2000
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K002509 · MUJ
Brainlab AG
Radiology · 80d
Cleared Nov 03, 2000
PILLING E-FRAZIER BIPOLAR SUCTION TUBE
K002582 · GEI
Pilling
General & Plastic Surgery · 77d
Cleared Nov 03, 2000
KSEA MINIATURE NEUROENDOSCOPE
K002704 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 65d
Cleared Nov 03, 2000
3D ENDOSCOPE
K002924 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 45d
Cleared Nov 03, 2000
PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
K003019 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 37d
Cleared Nov 03, 2000
HERMES PORT EXPANDER
K003217 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 21d
Cleared Nov 03, 2000
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K003222 · GCI
Computer Motion, Inc.
General & Plastic Surgery · 18d
Cleared Nov 03, 2000
RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE
K003233 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 17d
Cleared Nov 03, 2000
BIOMET LATERAL TROCH PLATE
K003294 · JDW
Biomet, Inc.
Orthopedic · 14d
Cleared Nov 02, 2000
QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3
K001249 · JJY
Consolidated Technologies of Wisconsin
Chemistry · 204d
Cleared Nov 02, 2000
ACCUWELL TSH, MODEL KAW-TSH-960
K001455 · JLW
Neometrics, Inc.
Chemistry · 177d
Cleared Nov 02, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL...
K001676 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 154d
Cleared Nov 02, 2000
SIMPLICITY SPINAL SYSTEM
K002103 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 113d
Cleared Nov 02, 2000
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
K002390 · JFB
Lsi Intl., Inc.
Physical Medicine · 90d
Cleared Nov 02, 2000
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
K002392 · GWM
Integra Neurocare, LLC
Neurology · 87d
Cleared Nov 02, 2000
MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
K002456 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 84d