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
47065–47088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 2011
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K110696 · ETN
Baxano, Inc.
Ear, Nose, Throat · 115d
Cleared Jul 07, 2011
APNEA RISK EVALUATION SYSTEM (ARES)
K111194 · MNR
Advanced Brain Monitoring, Inc.
Anesthesiology · 70d
Cleared Jul 06, 2011
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
K092688 · LFR
Taidoc Technology Corporation
Chemistry · 673d
Cleared Jul 06, 2011
REVLOK FENESTRATED SCREW SYSTEM
K110280 · NKB
Globus Medical, Inc.
Orthopedic · 156d
Cleared Jul 06, 2011
FIGURE 8 STERNOTOMY CLOSURE DEVICE
K110541 · JDQ
Figure 8 Surgical, Incorporated
Orthopedic · 131d
Cleared Jul 06, 2011
PARKER 500
K110994 · ILJ
Arjohuntleigh, Inc.
Physical Medicine · 89d
Cleared Jul 06, 2011
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE...
K111012 · LYZ
True Glove Factory
General Hospital · 85d
Cleared Jul 06, 2011
OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
K111326 · HRS
Graham Medical Technologies, LLC
Orthopedic · 56d
Cleared Jul 06, 2011
PLATEAU SPACER SYSTEM
K111569 · MAX
Life Spine
Orthopedic · 30d
Cleared Jul 06, 2011
VIPER SYSTEMS
K111571 · NKB
Johnson & Johnson
Orthopedic · 30d
Cleared Jul 06, 2011
MODIFIED CONCENTRIC MICROCATHETER
K111619 · DQO
Concentric Medical, Inc.
Cardiovascular · 26d
Cleared Jul 05, 2011
WIRELESS MONITORING SYSTEM
K110809 · DRG
Carefusion 303, Inc.
Cardiovascular · 104d
Cleared Jul 05, 2011
VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
K110880 · JJY
Maine Standards Company, LLC
Chemistry · 97d
Cleared Jul 05, 2011
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
K110925 · MQV
Novabone Products, LLC
Orthopedic · 95d
Cleared Jul 05, 2011
ASCOM MOBILE MONITORING GATEWAY (MMG)
K111215 · MSX
Ascom (Sweden) AB
Cardiovascular · 64d
Cleared Jul 05, 2011
SV DBS VRAIN ARRAY
K111259 · MOS
Midwest Rf, LLC
Radiology · 62d
Cleared Jul 05, 2011
TOTAL SHOULDER SYSTEM
K111596 · KWS
Shoulder Innovations, LLC
Orthopedic · 27d
Cleared Jul 01, 2011
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO,...
K101306 · GEX
Fotona D.D.
General & Plastic Surgery · 417d
Cleared Jul 01, 2011
ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK
K102648 · MAV
Shenzhen Ant Hi-Tech Industrial Co.,...
Cardiovascular · 290d
Cleared Jul 01, 2011
ATLANTEAN TRIGGER NEBULIZER
K102719 · CAF
Atlantean Corporation
Anesthesiology · 283d
Cleared Jul 01, 2011
WELL-LIFE OTC EMS SYSTEM
K102786 · NGX
Well-Life Healthcare Limited
Physical Medicine · 277d
Cleared Jul 01, 2011
PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150
K103563 · CAW
Precision Medical, Inc.
Anesthesiology · 207d
Cleared Jul 01, 2011
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
K103776 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 186d
Cleared Jul 01, 2011
SIMPLANT 2011
K110300 · LLZ
Materialise Dental NV
Radiology · 149d