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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
46321–46344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2011
MOBICATH TRANSSEPTAL NEEDLE
K111644 · DRC
Great Batch Medical
Cardiovascular · 112d
Cleared Oct 03, 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER
K111735 · PHX
Encore Medical, L.P.
Orthopedic · 104d
Cleared Oct 03, 2011
ARMADA 35/35LL PTA CATHETER
K111899 · LIT
Abbott Vascular
Cardiovascular · 90d
Cleared Oct 03, 2011
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
K112228 · LON
bioMerieux, Inc.
Microbiology · 61d
Cleared Sep 30, 2011
DYNAMIC ECG SYSTEM MODEL TLC5000
K101273 · MLO
Contec Medical System Co., Ltd.
Cardiovascular · 512d
Cleared Sep 30, 2011
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K102673 · DHR
Phadia US, Inc.
Immunology · 379d
Cleared Sep 30, 2011
DISCOVERY MR750W 3.0T
K103327 · LNH
Ge Healthcare Japan Corporation
Radiology · 322d
Cleared Sep 30, 2011
NEUROVISION NERVE LOCATOR MONITOR
K110140 · GWF
Neurovision Medical Products, Inc.
Neurology · 255d
Cleared Sep 30, 2011
FREERIDER MODEL LUGGIE MODEL 168-4IT
K110165 · INI
Freerider Luggie Scooters, Inc.
Physical Medicine · 254d
Cleared Sep 30, 2011
LDR SPINE ROI-A INTERBODY FUSION SYSTEM
K110327 · OVD
Ldr Spine USA
Orthopedic · 239d
Cleared Sep 30, 2011
TAPERLOC COMPLETE MICROPLASTY STEM
K110400 · KWA
Biomet Manufacturing Corp
Orthopedic · 231d
Cleared Sep 30, 2011
PHILIPS INTELLIVUE TCG10
K110474 · LKD
Philips Medizinsysteme Boeblingen...
Anesthesiology · 224d
Cleared Sep 30, 2011
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
K110846 · JJW
Randox Laboratories Limited
Chemistry · 186d
Cleared Sep 30, 2011
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
K110904 · JJY
Randox Laboratories, Ltd.
Chemistry · 183d
Cleared Sep 30, 2011
SURGIMAP (TM) SPINE
K111019 · LLZ
Nemaris, Inc.
Radiology · 171d
Cleared Sep 30, 2011
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
K111366 · FOZ
Becton, Dickinson and Company (BD)
General Hospital · 137d
Cleared Sep 30, 2011
SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK
K111412 · GEI
Steerable Technologix
General & Plastic Surgery · 133d
Cleared Sep 30, 2011
APEX
K111676 · IXI
Elekta Limited
Radiology · 107d
Cleared Sep 30, 2011
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
K111865 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 92d
Cleared Sep 30, 2011
IMAGELINK
K112096 · LLZ
Computer Programs and Systems, Inc.
Radiology · 70d
Cleared Sep 30, 2011
HTS EXTREMITY COIL, HTS SURFACE COIL
K112293 · MOS
Time Medical Systems, Inc.
Radiology · 51d
Cleared Sep 30, 2011
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K112320 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Sep 30, 2011
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
K112442 · GEX
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 37d
Cleared Sep 30, 2011
3DI INCLUDING CSCORE
K112530 · LLZ
Shina Systems , Ltd.
Radiology · 30d