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

Filters: Cleared only ×
176,076 results
65497–65520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 2005
NOBELREPLACE ADAPTER, MODEL 32412
K050444 · NHA
Nobel Biocare Uas, Inc.
Dental · 135d
Cleared Jul 07, 2005
QUANTUM VERTEBRAL BODY REPLACEMENT
K050449 · MQP
Quantum Orthopedics, Inc.
Orthopedic · 135d
Cleared Jul 07, 2005
SMARTECH, MODEL HOLI I
K050507 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 129d
Cleared Jul 07, 2005
CONNEXUS
K050690 · MQV
Isotis Orthobiologics, Inc.
Orthopedic · 112d
Cleared Jul 07, 2005
LANDLEX MODEL S400X
K050793 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 101d
Cleared Jul 07, 2005
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
K050832 · JCT
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 97d
Cleared Jul 07, 2005
PALACOS LV+G
K050854 · LOD
Heraeus Kulzer,GmbH
Orthopedic · 94d
Cleared Jul 07, 2005
PALAMED G
K050855 · LOD
Heraeus Kulzer,GmbH
Orthopedic · 94d
Cleared Jul 07, 2005
PIVOT BIPOLAR FEMORAL HEAD
K050966 · KWY
Ortho Development Corp.
Orthopedic · 80d
Cleared Jul 07, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
K051098 · HWC
Zimmer, Inc.
Orthopedic · 69d
Cleared Jul 07, 2005
MERETE TWISTCUT SNAP-OFF BONE SCREW
K051323 · HWC
Merete Medical GmbH
Orthopedic · 48d
Cleared Jul 07, 2005
NATURE-CRYL HI PLUS
K051358 · EBI
GC America, Inc.
Dental · 44d
Cleared Jul 07, 2005
POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR)
K051372 · LZA
Platinum Glove Industries Sdn. Bhd.
General Hospital · 42d
Cleared Jul 07, 2005
GE OEC EVERVIEW 7500
K051490 · OXO
Ge Oec Medical Systems, Inc.
Radiology · 31d
Cleared Jul 07, 2005
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
K051524 · BSO
Smiths Medical Asd, Inc.
Anesthesiology · 29d
Cleared Jul 07, 2005
FUJI SYNAPSE WORKSTATION SOFTWARE
K051553 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 24d
Cleared Jul 07, 2005
AXIOM SIRESKOP SD
K051602 · JAA
Siemens Medical Systems, Inc.
Radiology · 21d
Cleared Jul 07, 2005
T2 RECON NAIL SYSTEM
K051624 · HSB
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Jul 07, 2005
RN SYNOCTA TEMPORARY MESO ABUTMENT
K051717 · NHA
Institut Straumann SA
Dental · 10d
Cleared Jul 06, 2005
JAUNDICE METER, MODEL JM 103
K042522 · MQM
Draeger Medical Infant Care, Inc.
Chemistry · 293d
Cleared Jul 06, 2005
QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
K042725 · DJG
Quest Diagnostics, Inc.
Chemistry · 278d
Cleared Jul 06, 2005
COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES
K043238 · CAF
Emg Technology Co., Ltd.
Anesthesiology · 226d
Cleared Jul 06, 2005
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
K050231 · JIT
Roche Diagnostics Corp.
Immunology · 161d
Cleared Jul 06, 2005
EXPEDIUM SPINE SYSTEM
K051024 · NKB
Depuy Spine, Inc.
Orthopedic · 75d