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
72313–72336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2003
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
K030682 · LYC
Bioform, Inc.
Dental · 114d
Cleared Jun 27, 2003
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090
K030687 · DAP
Kamiya Biomedical Co.
Hematology · 114d
Cleared Jun 27, 2003
BLACKSTONE SURGICAL TITANIUM MESH
K030744 · MQP
Blackstone Medical, Inc.
Orthopedic · 109d
Cleared Jun 27, 2003
WARTNER PRO
K030838 · GEH
Wartner Medical Products
General & Plastic Surgery · 102d
Cleared Jun 27, 2003
EBV VCA-P18 IGG ELISA
K030863 · LSE
Panbio Limited
Microbiology · 101d
Cleared Jun 27, 2003
HI-FLO THERME PNEU 45, WISAP #7083, 7083V
K031014 · HIF
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 88d
Cleared Jun 27, 2003
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
K031023 · HQF
Peregrine Surgical , Ltd.
Ophthalmic · 88d
Cleared Jun 27, 2003
ETI BIPOLAR HEMOSTATIC PROBE
K031026 · KNS
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 27, 2003
YA MEI FIRST AID KIT
K031130 · KGO
Ya Mei Technology Co., Ltd.
General Hospital · 79d
Cleared Jun 27, 2003
ORTHOMEND
K031188 · FTL
Tei Biosciences, Inc.
General & Plastic Surgery · 73d
Cleared Jun 27, 2003
SUSTAIN SPACER
K031302 · MQP
Globus Medical, Inc.
Orthopedic · 64d
Cleared Jun 27, 2003
EBI P148 SPINAL FIXATION SYSTEM
K031423 · MNH
Ebi, L.P.
Orthopedic · 52d
Cleared Jun 27, 2003
BLASTFREEZE AND BLASTTHAW
K031486 · MQL
Medicult A/S
Obstetrics & Gynecology · 46d
Cleared Jun 27, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K031521 · LPN
Ciba Vision Corporation
Ophthalmic · 43d
Cleared Jun 27, 2003
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K031522 · LPN
Ciba Vision Corporation
Ophthalmic · 43d
Cleared Jun 27, 2003
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
K031538 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 42d
Cleared Jun 27, 2003
U&I, OPTIMA, SPINAL SYSTEM
K031585 · MNH
U&I Corp., America
Orthopedic · 37d
Cleared Jun 27, 2003
CD HORIZON SPINAL SYSTEM
K031655 · MNI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jun 27, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031888 · MNI
Medtronic Sofamor Danek
Orthopedic · 9d
Cleared Jun 26, 2003
SMART BAG MO
K021328 · BTM
O-Two Systems International, Inc.
Anesthesiology · 426d
Cleared Jun 26, 2003
OSMONICS SOLUTION DELIVERY SYSTEM
K023011 · FIN
Osmonics Medical Systems
Gastroenterology & Urology · 290d
Cleared Jun 26, 2003
METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON...
K024000 · DQO
Angiometrx, Inc.
Cardiovascular · 204d
Cleared Jun 26, 2003
PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM
K024181 · IPF
Prizm Medical, Inc.
Physical Medicine · 189d
Cleared Jun 26, 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · MNH
Blackstone Medical, Inc.
Orthopedic · 122d