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
68377–68400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2004
2 CM PERIPHERAL CUTTING BALOON
K041993 · PNO
Boston Scientific Ivt
Cardiovascular · 24d
Cleared Aug 16, 2004
PHACO CHOP NEEDLES
K041998 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 21d
Cleared Aug 16, 2004
CYPRESS ULTRASOUND SYSTEM
K042055 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Aug 16, 2004
NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL
K042103 · MOS
Mri Devices Corporation
Radiology · 12d
Cleared Aug 13, 2004
DURALITE-GL
K041262 · GEX
Laser Scientific
General & Plastic Surgery · 94d
Cleared Aug 13, 2004
IMMUNOCARD STAT! RSV MODEL #750630
K041445 · GQG
Meridian Bioscience, Inc.
Microbiology · 73d
Cleared Aug 13, 2004
ACUSON CV70 CARDIOVASCULAR SYSTEM
K042044 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Aug 13, 2004
DENFIL
K042124 · EBF
Vericom Co., Ltd.
Dental · 7d
Cleared Aug 12, 2004
PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS...
K032192 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 392d
Cleared Aug 12, 2004
SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300
K033027 · GEI
Shining World Health Care Co., Ltd.
General & Plastic Surgery · 321d
Cleared Aug 12, 2004
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
K033843 · FOZ
Cook, Inc.
General Hospital · 246d
Cleared Aug 12, 2004
HANSON SCAR ADE
K040307 · MDA
Hanson Medical, Inc.
General & Plastic Surgery · 185d
Cleared Aug 12, 2004
HEALICOLL
K040314 · KGN
Encoll Corp.
General & Plastic Surgery · 185d
Cleared Aug 12, 2004
NUNC IVF MULTIDISH 4 WELLS NUNCLON
K040717 · MQK
Nunc A/S
Obstetrics & Gynecology · 146d
Cleared Aug 12, 2004
POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)
K040792 · LYY
Pt. Smartglove Indonesia
General Hospital · 136d
Cleared Aug 12, 2004
FLO-RITE
K041057 · NFB
Ameriflo Corp.
Anesthesiology · 111d
Cleared Aug 12, 2004
ARCHITECT STAT TROPONIN-I IMMUNOASSAY
K041192 · MMI
Fisher Diagnostics
Chemistry · 98d
Cleared Aug 12, 2004
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202 · KHE
W.H.P.M., Inc.
Hematology · 97d
Cleared Aug 12, 2004
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · HCC
Medtronic Vascular
Neurology · 93d
Cleared Aug 12, 2004
POLYMEDCO OC LIGHT FOBT TEST
K041297 · KHE
Polymedco, Inc.
Hematology · 90d
Cleared Aug 12, 2004
MODIFICATION TO NC-STAT
K041320 · JXE
Neurometrix, Inc.
Neurology · 86d
Cleared Aug 12, 2004
HOVERJACK AIR PATIENT LIFT DEVICE
K041503 · FNG
D.T. Davis Enterprises , Ltd.
General Hospital · 66d
Cleared Aug 12, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML
K041572 · LON
Becton, Dickinson and Co.
Microbiology · 59d
Cleared Aug 12, 2004
XPS CURVED BUR
K041985 · EQJ
Medtronic Xomed, Inc.
Ear, Nose, Throat · 20d