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
52465–52488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2009
CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4...
K092357 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 21d
Cleared Aug 21, 2009
TANTALUM BEAD SET, MODEL P003175
K090581 · NEU
Halifax Biomedical, Inc.
General & Plastic Surgery · 171d
Cleared Aug 21, 2009
XTRACT SYRINGE KEYS
K091200 · FMF
Xtract Solutions, LLC
General Hospital · 119d
Cleared Aug 21, 2009
AMSURE PVC INTERMITTENT CATHETER
K091306 · EZD
Amsino International, Inc.
Gastroenterology & Urology · 109d
Cleared Aug 21, 2009
CLEAN PEAK FLOW METER
K091412 · BZH
Viasys Healthcare GmbH
Anesthesiology · 100d
Cleared Aug 21, 2009
CARE PAL, MODEL CPW-10X
K091430 · DRG
Digio2 International Co., Ltd.
Cardiovascular · 99d
Cleared Aug 21, 2009
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
K091452 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 95d
Cleared Aug 21, 2009
MYOSURE ROD LENS HYSTEROSCOPE
K091465 · HIH
Interlace Medical, Inc.
Obstetrics & Gynecology · 95d
Cleared Aug 21, 2009
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
K091628 · IXW
Protec GmbH & Co. KG
Radiology · 78d
Cleared Aug 21, 2009
1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL...
K091902 · MOS
Invivo
Radiology · 57d
Cleared Aug 21, 2009
GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND
K092140 · IYO
Ge Medical Systems Israel,...
Radiology · 37d
Cleared Aug 21, 2009
MERCURY VCO2
K092217 · BZK
Respironics Novametrix, Inc.
Anesthesiology · 30d
Cleared Aug 21, 2009
SKINTACT AND VARIOUS OTHER TRADENAMES
K092291 · DRX
Leonhard Lang GmbH
Cardiovascular · 23d
Cleared Aug 20, 2009
BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP
K082977 · LDJ
Mk Bio, Inc.
Toxicology · 318d
Cleared Aug 20, 2009
CABLE, TRANSDUCER, MODEL 2400GN
K083448 · DQA
Conmed Corporation
Anesthesiology · 272d
Cleared Aug 20, 2009
TERUMO PALL AL3X ARTERIAL FILTER
K083747 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 246d
Cleared Aug 20, 2009
MERCURY CPAP
K090710 · BYE
Mercury Medical
Anesthesiology · 155d
Cleared Aug 20, 2009
TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE
K090783 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 150d
Cleared Aug 20, 2009
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064,...
K090960 · GBM
Hollister, Inc.
Gastroenterology & Urology · 136d
Cleared Aug 20, 2009
LSVT C OR LSVT COMPANION, MODEL V.1
K091682 · LEZ
Lsvt Global, LLC
Ear, Nose, Throat · 71d
Cleared Aug 20, 2009
MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH
K092053 · EGS
Handpiece Headquarters
Dental · 44d
Cleared Aug 20, 2009
ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE
K092201 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Aug 20, 2009
THERMAPULSE
K092222 · ILY
Palomar Medical Products, Inc.
Physical Medicine · 28d
Cleared Aug 20, 2009
MODIFICATION TO PROFLU+ ASSAY
K092500 · OCC
Prodesse, Inc.
Microbiology · 6d