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
56377–56400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2008
MODIFICATION TO CORAL SPINAL SYSTEM
K081414 · NKB
Theken Spine, LLC
Orthopedic · 28d
Cleared Jun 17, 2008
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
K081439 · MQV
Orthovita, Inc.
Orthopedic · 26d
Cleared Jun 17, 2008
INFX-8000V, INFINIX-CFI AND INFINIX VFI
K081582 · JAA
Toshiba America Medical Systems, In.C
Radiology · 12d
Cleared Jun 16, 2008
AXIS FIXATION SYSTEM
K062254 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 682d
Cleared Jun 16, 2008
MODIFICATION TO: SPIRIT
K080023 · BYJ
Caire, Inc.
Anesthesiology · 164d
Cleared Jun 13, 2008
ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
K073416 · CGA
Arkray Factory USA, Inc.
Chemistry · 193d
Cleared Jun 13, 2008
BARD DIGNICARE STOOL MANAGEMENT SYSTEM
K073598 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 175d
Cleared Jun 13, 2008
SURGICRAFT SCREW FIXATION SYSTEM
K080447 · MBI
Surgicraft , Ltd.
Orthopedic · 115d
Cleared Jun 13, 2008
PRISMAFLEX M150 SET
K080519 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 109d
Cleared Jun 13, 2008
SWC/DWC WARMING CABINETS
K080609 · LHC
Mac Medical
General Hospital · 102d
Cleared Jun 13, 2008
FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057
K080902 · GXY
Lorenz Biotech S.P.A.
Neurology · 72d
Cleared Jun 13, 2008
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
K081164 · LIN
Diagnostic Hybrids, Inc.
Microbiology · 50d
Cleared Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
K081212 · JSO
Bio-Rad
Microbiology · 45d
Cleared Jun 13, 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381 · MNH
K2m, Inc.
Orthopedic · 28d
Cleared Jun 13, 2008
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
K081454 · MJN
Possis Medical, Inc.
Cardiovascular · 21d
Cleared Jun 13, 2008
WATERLASE, VERSION 3.0
K081589 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 8d
Cleared Jun 12, 2008
ENDSNOR
K072731 · LRK
Dockstader Orthodontic Lab, Inc.
Dental · 260d
Cleared Jun 12, 2008
ETHICON ENDO SURGERY ARTICULATING SNARE
K073288 · FDI
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 204d
Cleared Jun 12, 2008
SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2
K081469 · LLZ
Sectra-Imtec AB
Radiology · 16d
Cleared Jun 12, 2008
OPTIMA PET/CT 560
K081496 · KPS
Ge Medical Systems, LLC
Radiology · 14d
Cleared Jun 11, 2008
SIGMA SERIES HYPERBARIC CHAMBER
K072427 · CBF
Perry Baromedical Corp.
Anesthesiology · 287d
Cleared Jun 11, 2008
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
K080088 · HWC
Biomet Manufacturing, Inc.
Orthopedic · 149d
Cleared Jun 11, 2008
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
K080180 · HKI
Optical Imaging , Ltd.
Ophthalmic · 139d
Cleared Jun 11, 2008
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A...
K080330 · KRO
Biomet, Inc.
Orthopedic · 126d