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
71185–71208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2003
RADIUS COUGAR WIRE
K032899 · DQX
Radius Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Oct 17, 2003
NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210
K032947 · DQA
Dolphin Medical, Inc.
Anesthesiology · 25d
Cleared Oct 16, 2003
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND...
K030857 · EOB
Mahe Intl., Inc.
Ear, Nose, Throat · 212d
Cleared Oct 16, 2003
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294
K031012 · FRC
3M Company
General Hospital · 199d
Cleared Oct 16, 2003
UUHC REPROCESSED COMPRESSION SLEEVE DEVICES
K031189 · JOW
University of Utah Hospitals and Clinics
Cardiovascular · 184d
Cleared Oct 16, 2003
STRYKER FLEXIBLE URETEROSCOPE
K031278 · FGB
Stryker Endoscopy
Gastroenterology & Urology · 177d
Cleared Oct 16, 2003
POWDER FREE LATEX EXAM GLOVES
K031335 · LYY
Tan Sin Lian Industries Sdn. Bhd.
General Hospital · 171d
Cleared Oct 16, 2003
EASYGLUCO, MODEL IGM0002
K031501 · NBW
American Healthcare, Inc.
Chemistry · 156d
Cleared Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966 · EOQ
Cook, Inc.
Ear, Nose, Throat · 112d
Cleared Oct 16, 2003
LTV-1000 VENTILATOR
K032226 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 87d
Cleared Oct 16, 2003
MODEL IR 1200 INSULIN PUMP
K032257 · LZG
Animas Corp.
General Hospital · 86d
Cleared Oct 16, 2003
VISTAKON (GALYFILCON A) SOFT CONTACT LENS
K032340 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 79d
Cleared Oct 16, 2003
MAGNETOM AVANTO MR SYSTEM
K032428 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Oct 16, 2003
PROWESS
K032456 · MUJ
Prowess, Inc.
Radiology · 66d
Cleared Oct 16, 2003
AUTOSET SPIRIT SYSTEM
K032480 · BZD
Resmed, Ltd.
Anesthesiology · 65d
Cleared Oct 16, 2003
INTELEPACS
K032533 · LLZ
Intelerad Medical Systems, Inc.
Radiology · 62d
Cleared Oct 16, 2003
HOLOGIC DR IMAGEPRO
K032546 · LLZ
Hologic, Inc.
Radiology · 59d
Cleared Oct 16, 2003
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
K033009 · CIX
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Oct 16, 2003
ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109
K033099 · FPA
Applied Diabetes Research, Incorporated
General Hospital · 17d
Cleared Oct 16, 2003
SONOLINE ANTARES WITH CLARIFY VE
K033196 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 16, 2003
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND...
K033225 · EOQ
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 10d
Cleared Oct 16, 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K033244 · OWB
Ge Medical Systems, Inc.
Radiology · 9d
Cleared Oct 15, 2003
ACURA ELITE GRAVITY COMPENSATING RESERVOIR
K030468 · JXG
Phoenix Biomedical Corp.
Neurology · 245d
Cleared Oct 15, 2003
BREAS PV 10I CPAP SYSTEM, MODEL PV 10I
K030985 · BZD
Vital Signs, Inc.
Anesthesiology · 201d