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
55297–55320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2008
ELLIPSE MULTIFLEX
K081408 · GEX
Ellipse A/S
General & Plastic Surgery · 151d
Cleared Oct 17, 2008
MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
K081438 · DXZ
Lifenet Health
Cardiovascular · 148d
Cleared Oct 17, 2008
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM,...
K081475 · HBE
Medtronic Xomed, Inc.
Neurology · 143d
Cleared Oct 17, 2008
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
K081594 · LZA
Medline Industries, Inc.
General Hospital · 133d
Cleared Oct 17, 2008
SPIRALFUSE PERIPHERAL INFUSION SYSTEM
K082199 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 74d
Cleared Oct 17, 2008
INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES
K082260 · MAX
Calvary Spine, LLC
Orthopedic · 70d
Cleared Oct 17, 2008
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K082370 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 60d
Cleared Oct 17, 2008
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K082375 · HTY
OrthoPediatrics Corp.
Orthopedic · 60d
Cleared Oct 17, 2008
P3T ABDOMEN
K082458 · JAK
Medrad, Inc.
Radiology · 52d
Cleared Oct 17, 2008
STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
K082545 · NHA
Institut Straumann AG
Dental · 44d
Cleared Oct 17, 2008
NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I,...
K082599 · DXN
Cnsystem Medizintechnik AG
Cardiovascular · 39d
Cleared Oct 17, 2008
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
K082640 · OTM
Coloplast Manufacturing Us, LLC
Gastroenterology & Urology · 37d
Cleared Oct 17, 2008
COLLAMEND FM IMPLANT
K082687 · FTM
C.R. Bard, Inc.
General & Plastic Surgery · 32d
Cleared Oct 17, 2008
MICRUS MICROCOIL DELIVERY SYSTEM
K082739 · HCG
Micrus Endovascular Corporation
Neurology · 29d
Cleared Oct 17, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K082797 · NKB
Blackstone Medical, Inc.
Orthopedic · 24d
Cleared Oct 17, 2008
ENCAGE BIPOLAR RF PROBE
K082954 · GEI
Trod Medical SA
General & Plastic Surgery · 14d
Cleared Oct 17, 2008
GE XTREME INJECTOR OPTION
K082960 · JAK
Ge Medical Systems, LLC
Radiology · 14d
Cleared Oct 17, 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
K083014 · MOS
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Oct 16, 2008
VB IMAGE VIEWER
K080581 · JAK
Olympus Medical Systems Corporation
Radiology · 227d
Cleared Oct 16, 2008
FIRMGRIP
K080793 · FOZ
Flexicath , Ltd.
General Hospital · 210d
Cleared Oct 16, 2008
SPINAL USA VBR SYSTEM
K081196 · MAX
Spinal USA
Orthopedic · 171d
Cleared Oct 16, 2008
NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL...
K081759 · HRS
Zimmer GmbH
Orthopedic · 118d
Cleared Oct 16, 2008
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
K082051 · GXD
Cosman Medical, Inc.
Neurology · 90d
Cleared Oct 16, 2008
CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE...
K082258 · FXX
Crosstex International
General Hospital · 69d