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

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175,820 results
45889–45912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · MRW
Exactech, Inc.
Orthopedic · 122d
Cleared Nov 21, 2011
COMPONEER
K112168 · EBF
Coltene/Whaledent AG
Dental · 116d
Cleared Nov 21, 2011
CLYDESDALES SPINAL SYSTEM
K112405 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 91d
Cleared Nov 21, 2011
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
K112425 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 90d
Cleared Nov 21, 2011
PASS LP SPINAL SYSTEM
K112493 · MNI
Medicrea International
Orthopedic · 84d
Cleared Nov 21, 2011
S4 SPINAL SYSTEM
K112551 · NKB
Aesculap Implant System, Inc.
Orthopedic · 81d
Cleared Nov 21, 2011
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
K112724 · KWQ
Medos International SARL
Orthopedic · 63d
Cleared Nov 21, 2011
CD HORIZON SPINAL SYSTEM
K113174 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 25d
Cleared Nov 21, 2011
CHIBA SONO
K113209 · KNW
Pajunk GmbH
Gastroenterology & Urology · 21d
Cleared Nov 18, 2011
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
K102833 · MPB
Foshan Nanhai Bai HE Medical...
Gastroenterology & Urology · 415d
Cleared Nov 18, 2011
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL...
K103376 · JFY
Seppim S.A.S.
Chemistry · 366d
Cleared Nov 18, 2011
HIGH FLOW INSUFFLATION UNIT UHI-4
K110294 · HIF
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 290d
Cleared Nov 18, 2011
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
K110560 · JXG
Medtronic Neurosurgery
Neurology · 263d
Cleared Nov 18, 2011
MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM
K110596 · LLZ
Wide Corporation
Radiology · 261d
Cleared Nov 18, 2011
AVO BARRIER TOPICAL EMULSION
K110762 · FRO
Trigen Laboratories, Inc.
General & Plastic Surgery · 245d
Cleared Nov 18, 2011
AMBU ASCOPE 2
K110962 · BTR
Ambu A/S
Anesthesiology · 226d
Cleared Nov 18, 2011
OSSEOTITE 2 DENTAL IMPLANTS
K111216 · DZE
Biomet 3i, Inc.
Dental · 200d
Cleared Nov 18, 2011
PIEZO BONE SURGERY
K111290 · DZI
Guilin Woodpecker Medical Instrument...
Dental · 196d
Cleared Nov 18, 2011
SYNTHES USS
K111358 · NKB
Synthes Spine
Orthopedic · 186d
Cleared Nov 18, 2011
GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
K111593 · NDN
Bm Korea Co., Ltd.
Orthopedic · 164d
Cleared Nov 18, 2011
ONCO TRAC MODEL 1, 2, 4
K111642 · LLZ
Translational Sciences Corporation
Radiology · 158d
Cleared Nov 18, 2011
FOUNDATION DENTAL RESIN
K111709 · EBI
Unix-Japan Co., Ltd.
Dental · 151d
Cleared Nov 18, 2011
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS...
K111960 · KHS
Elitechgroup
Chemistry · 130d
Cleared Nov 18, 2011
VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
K111983 · ODP
Zimmer Trabecular Metal Technology
Orthopedic · 129d