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
47329–47352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 2011
MYLABGOLD
K110688 · IYO
Esaote
Radiology · 83d
Cleared Jun 02, 2011
TORNIER INSITE FT SUTURE ANCHOR
K110773 · MBI
Tornier, Inc.
Orthopedic · 73d
Cleared Jun 02, 2011
ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
K111252 · DQY
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 01, 2011
INVADER FACTOR V
K100980 · NPQ
Hologic, Inc.
Pathology · 419d
Cleared Jun 01, 2011
UNIT, PHACOFRAGMENTATION
K103023 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 232d
Cleared Jun 01, 2011
MIS ANTERIOR CERVICAL PLATING SYSTEM
K103423 · KWQ
Life Spine
Orthopedic · 191d
Cleared Jun 01, 2011
H-WAVE
K103738 · IPF
Electronic Waveform Laboratory, Inc.
Physical Medicine · 161d
Cleared Jun 01, 2011
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
K110398 · BZE
Respironics, Inc.
Anesthesiology · 110d
Cleared Jun 01, 2011
CONNEX VITAL SIGNS MONITOR 6000 SERIES
K110516 · MWI
Welch Allyn, Inc.
Cardiovascular · 98d
Cleared CT Jun 01, 2011
JETSTREAM G3 (R) SF 1.6 SYSTEM
K111229 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared May 31, 2011
FORCETRIAD ELECTROSURGICAL GENERATOR
K110268 · GEI
Covidien Lp, Formerly Know AS...
General & Plastic Surgery · 123d
Cleared May 31, 2011
M4 MONITOR
K110957 · DRY
Spectrum Medical, Llp
Cardiovascular · 56d
Cleared May 31, 2011
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
K111295 · LIT
Boston Scientific Corporation
Cardiovascular · 21d
Cleared May 27, 2011
MEDAX UNIPERSONALE SRL
K092338 · KNW
Medax Unipersonale Srl
Gastroenterology & Urology · 661d
Cleared May 27, 2011
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
K100895 · LYY
Dipped Products Limited
General Hospital · 422d
Cleared May 27, 2011
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE,...
K101251 · DHB
Phadia AB
Immunology · 388d
Cleared May 27, 2011
TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
K101681 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 346d
Cleared May 27, 2011
KONIX ULTRASOUND GEL
K101952 · ITX
Turkuaz Saglik Hizmetleri Medikal...
Radiology · 319d
Cleared May 27, 2011
CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
K102049 · NBW
Taidoc Technology Corporation
Chemistry · 310d
Cleared May 27, 2011
INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818...
K102935 · FLL
Kingtech Enterprise, Ltd.
General Hospital · 235d
Cleared May 27, 2011
PEAK SUCTION COAGULATOR
K103775 · GEI
Peak Surgical, Inc.
General & Plastic Surgery · 151d
Cleared May 27, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K110097 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 134d
Cleared May 27, 2011
DIRECTVISION CATHETER, UNCOATED
K110214 · EZL
Percuvision
Gastroenterology & Urology · 122d
Cleared May 27, 2011
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
K110226 · MAX
Vertebral Technologies, Inc.
Orthopedic · 122d