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
37801–37824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2014
HICUT HIGHSPEED INSTRUMENT
K130755 · HBE
Adeor Medical AG
Neurology · 465d
Cleared Jun 27, 2014
EUROIMMUN ANTI-PLA2R ELISA (IGG)
K132195 · PGV
Euroimmun Us, Inc.
Immunology · 347d
Cleared Jun 27, 2014
MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE...
K133260 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 247d
Cleared Jun 27, 2014
PERICAN ULTRA
K133632 · BSP
B.Braun Medical, Inc.
Anesthesiology · 213d
Cleared Jun 27, 2014
SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER
K133843 · LIT
Cordis Corporation
Cardiovascular · 191d
Cleared Jun 27, 2014
PARI-PATH SURGICAL NAVIGATION SYSTEM
K133901 · JAK
Paritic, Inc.
Radiology · 189d
Cleared Jun 27, 2014
BIODENTINE
K140132 · KIF
Septodont
Dental · 161d
Cleared Jun 27, 2014
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
K140289 · KCT
Summit Medical, Inc.
General Hospital · 142d
Cleared Jun 27, 2014
NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER
K140542 · KMA
Rhinosystems, Inc.
Ear, Nose, Throat · 115d
Cleared Jun 27, 2014
HIVOX ELECTRIC STIMULATOR OTC TENS
K140650 · NUH
Hivox Biotek, Inc.
Neurology · 106d
Cleared Jun 27, 2014
NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG
K140701 · OQG
Novosource, Inc.
Orthopedic · 99d
Cleared Jun 27, 2014
P-STIM
K140788 · BWK
Biegler GmbH
Neurology · 88d
Cleared Jun 27, 2014
SURGICAL NAVIGATION ADVANCED PLATFORM
K140819 · LLZ
Surgical Theater, LLC
Radiology · 87d
Cleared Jun 27, 2014
PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER
K140823 · IYE
Varian Medical Systems, Inc.
Radiology · 87d
Cleared Jun 27, 2014
A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR
K141179 · DXN
A & D Co., Ltd.
Cardiovascular · 51d
Cleared Jun 27, 2014
CRC PC WITH SMART CHAMBER
K141413 · KPT
Capintec, Inc.
Radiology · 29d
Cleared Jun 27, 2014
MDMC-12133
K141428 · PGY
Barco N.V.
Radiology · 28d
Cleared Jun 27, 2014
DEVON CIRONA 6200 DVT
K141578 · JOW
Devon Medical
Cardiovascular · 14d
Cleared Jun 26, 2014
DIAMOND RATTLESNAKE SYSTEM
K133194 · KWQ
Eminent Spine
Orthopedic · 252d
Cleared Jun 26, 2014
CONSURE STOOL MANAGEMENT SYSTEM
K133465 · KNT
Consure Medical Pvt , Ltd.
Gastroenterology & Urology · 226d
Cleared Jun 26, 2014
MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
K133579 · MBI
Pontis Orthopaedics, LLC
Orthopedic · 217d
Cleared Jun 26, 2014
SURESIGNS VS3, SURESIGNS VS4
K133961 · DSJ
Philips Medical Systems
Cardiovascular · 184d
Cleared Jun 26, 2014
KANGLI PEDICLE SCREW SPINAL SYSTEM
K140053 · MNH
Suzhou Kangli Orthopaedics Instrument...
Orthopedic · 168d
Cleared Jun 26, 2014
MEDLEY GOLD
K140435 · LRK
American Dental Sleep Medicine, Ip, LLC
Dental · 125d