FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
91657–91680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1997
POWERHEART AECD
K970741 · MKJ
Cardiac Science, Inc.
Cardiovascular · 230d
Cleared Oct 16, 1997
BARD RAPIDFIRE MULTIPLE BAND LIGATOR
K971137 · MND
C.R. Bard, Inc.
Gastroenterology & Urology · 202d
Cleared Oct 16, 1997
REJOYN PENILE SUPPORT SYSTEM
K971576 · LKY
American Medtech
Gastroenterology & Urology · 174d
Cleared Oct 16, 1997
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K971883 · KWQ
Synthes (Usa)
Orthopedic · 147d
Cleared Oct 16, 1997
MOA BONE / M-SPHERE
K972143 · HPZ
Iop, Inc.
Ophthalmic · 132d
Cleared Oct 16, 1997
QUIX RAPID E. COLI O157 STRIP TEST
K972156 · GMZ
Guardian Scientific, Corp.
Microbiology · 129d
Cleared Oct 16, 1997
IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM
K972229 · IZI
Heartware, Inc.
Radiology · 125d
Cleared Oct 16, 1997
TBI STAND
K972709 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 87d
Cleared Oct 16, 1997
DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
K972792 · JDI
Howmedica Corp.
Orthopedic · 80d
Cleared Oct 16, 1997
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017 · KTT
Synthes (Usa)
Orthopedic · 64d
Cleared Oct 16, 1997
LEGACY/LEGACY-D TABLE
K973039 · IXR
GE Medical Systems
Radiology · 63d
Cleared Oct 16, 1997
DRTS REMOTE CONTROL DRAPE
K973067 · JAA
Minrad, Inc.
Radiology · 59d
Cleared Oct 16, 1997
VINTAGE HALO
K973247 · EIH
Shofu Dental Corp.
Dental · 48d
Cleared Oct 16, 1997
VERABOND 2V
K973265 · EJH
Aalba Dent, Inc.
Dental · 48d
Cleared Oct 16, 1997
BARD ENDOSCOPIC OVERTUBE (#000307)
K973500 · FED
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 16, 1997
SUNGLASSES
K973526 · HQY
Pyramid Handbags, Inc.
Ophthalmic · 28d
Cleared Oct 16, 1997
INFINTY DISTAL FEMORAL COMPONENT
K973530 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Oct 15, 1997
HARMAC TEMPORARY PACING CATHETER WITH BALLOON
K962833 · LDF
Harmac Medical Products, Inc.
Cardiovascular · 474d
Cleared Oct 15, 1997
ZIRCONIA CERAMIC FEMORAL HEAD
K972690 · LZO
Zimmer, Inc.
Orthopedic · 90d
Cleared Oct 15, 1997
ABC TOTAL ELBOW PROTHESIS
K972691 · JDB
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 15, 1997
(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN...
K972807 · LPL
Benz Research and Development Corp.
Ophthalmic · 79d
Cleared Oct 15, 1997
ESTEEM 1.5T MRI SYSTEM
K972826 · LNH
Elscint Mr, Inc.
Radiology · 78d
Cleared Oct 15, 1997
ULTRAFAST CT SCANNER
K972879 · JAK
Imatron, Inc.
Radiology · 71d
Cleared Oct 15, 1997
PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM
K972973 · IYO
Perception, Inc.
Radiology · 65d