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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68761–68784 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2004
PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM
K032815 · KWQ
Precision Surgery Limited
Orthopedic · 156d
Cleared Feb 12, 2004
LIAISON 25 OH VITAMIN D
K032844 · MRG
DiaSorin, Inc.
Chemistry · 154d
Cleared Feb 12, 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033011 · HAW
Zimmer, Inc.
Neurology · 139d
Cleared Feb 12, 2004
LEKSELL SURGIPLAN WITH IMAGEMERGE
K033340 · HAW
Elekta Instrument AB
Neurology · 118d
Cleared Feb 12, 2004
LIAISON N-TACT PTH
K033426 · CEW
DiaSorin, Inc.
Chemistry · 108d
Cleared Feb 12, 2004
MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE
K033718 · GAT
Arthrotek, Inc.
General & Plastic Surgery · 78d
Cleared Feb 12, 2004
SIREMOBILE C06
K040066 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Feb 12, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Feb 12, 2004
VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL...
K040118 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 23d
Cleared Feb 12, 2004
IQ GUIDE WIRE
K040140 · DQX
Boston Scientific Corp
Cardiovascular · 21d
Cleared Feb 11, 2004
WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
K023889 · MIU
Wiener Laboratories Saic
Microbiology · 447d
Cleared Feb 11, 2004
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL
K032305 · DXN
Omron Healthcare, Inc.
Cardiovascular · 201d
Cleared Feb 11, 2004
TRIO MONITOR MODEL 0998-00-0600
K032338 · MWI
Datascope Corp.
Cardiovascular · 197d
Cleared Feb 11, 2004
SYSMEX POCH-100I
K032677 · GKL
Sysmex America, Inc.
Hematology · 166d
Cleared Feb 11, 2004
LINVATEC 10K IRRIGATION SYSTEM
K033573 · HRX
Linvatec Corp.
Orthopedic · 90d
Cleared Feb 11, 2004
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
K040034 · MNI
Blackstone Medical, Inc.
Orthopedic · 34d
Cleared Feb 10, 2004
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K032067 · JAQ
Proxima Therapeutics, Inc.
Radiology · 222d
Cleared Feb 10, 2004
CURAD SILVER ACTIVE GEL BANDAGE
K032462 · FRO
Beiersdorf AG
General & Plastic Surgery · 183d
Cleared Feb 10, 2004
CURAD SILVER BANDAGE
K032463 · FRO
Beiersdorf AG
General & Plastic Surgery · 183d
Cleared Feb 10, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K032706 · JWY
Dade Behring, Inc.
Microbiology · 161d
Cleared Feb 10, 2004
LABONE MICRO-PLATE COTININE EIA
K033601 · DLJ
Labone, Inc.
Toxicology · 88d
Cleared Feb 10, 2004
POLARCATH PERIPHERAL DILATATION SYSTEM
K033622 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 84d
Cleared Feb 10, 2004
CAPIOX CARDIOTOMY RESERVOIR
K033800 · DTN
Terumo Cardiovascular Systems...
Cardiovascular · 67d
Cleared Feb 10, 2004
CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
K033840 · JOY
CellaVision AB
Hematology · 62d