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
52561–52584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 2009
UC-CARE WARMING SYSTEM
K090978 · GEH
UC-CARE , Ltd.
General & Plastic Surgery · 126d
Cleared Aug 10, 2009
SCALAR WAVE LASER SYSTEM
K091158 · ILY
Stellar Lasers
Physical Medicine · 111d
Cleared Aug 10, 2009
ACCELL EVO3C
K091193 · MBP
Isotis Orthobiologics, Inc.
Orthopedic · 109d
Cleared Aug 10, 2009
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
K091357 · FYA
Kimberly-Clark Corp.
General Hospital · 94d
Cleared Aug 10, 2009
POWERED VINYL PATIENT EXAMINATION GLOVES
K091521 · LYZ
Shijiazhuang Century Plastic Co., Ltd.
General Hospital · 80d
Cleared Aug 10, 2009
AMSURE HYDROPHILIC LATEX FOLEY CATHETER
K091699 · EZL
Amsino International, Inc.
Gastroenterology & Urology · 61d
Cleared Aug 07, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
K083053 · MST
Euroimmun Us, Inc.
Immunology · 297d
Cleared Aug 07, 2009
ECOCEL
K083087 · KMF
Polichem S.A
General & Plastic Surgery · 295d
Cleared Aug 07, 2009
I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT
K083429 · FOZ
Weihai Jierui Medical Products Co., Ltd.
General Hospital · 261d
Cleared Aug 07, 2009
VERIFY 275F GRAVITY INDICATORS
K083643 · JOJ
STERIS Corporation
General Hospital · 241d
Cleared Aug 07, 2009
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X...
K090002 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 217d
Cleared Aug 07, 2009
SIGNAL
K090493 · DQD
Zargis Medical Corp.
Cardiovascular · 163d
Cleared Aug 07, 2009
BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R),...
K090586 · GEI
Bovie Medical
General & Plastic Surgery · 156d
Cleared Aug 07, 2009
DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%
K090791 · FRO
Century Pharmaceuticals, Inc.
General & Plastic Surgery · 136d
Cleared Aug 07, 2009
KOWA, FM-600, MODEL LSS50
K091039 · MYC
Kowa Co. , Ltd.
Ophthalmic · 116d
Cleared Aug 07, 2009
RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL...
K091041 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 116d
Cleared Aug 07, 2009
KOWAGENESIS-DF
K091098 · HKI
Kowa Co. , Ltd.
Ophthalmic · 113d
Cleared Aug 07, 2009
HORIZON XVU
K091165 · DQK
Mennen Medical , Ltd.
Cardiovascular · 107d
Cleared Aug 07, 2009
SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET
K091324 · LJS
C.R. Bard, Inc.
General Hospital · 94d
Cleared Aug 07, 2009
IBEX SPINAL SYSTEM
K091381 · MAX
Ebi, L.P.
Orthopedic · 88d
Cleared Aug 07, 2009
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
K091385 · DQX
Cook, Inc.
Cardiovascular · 89d
Cleared Aug 07, 2009
AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
K091548 · MKJ
Amco International Manufacturing &...
Cardiovascular · 72d
Cleared Aug 07, 2009
PHARMAPAC PERSONAL LUBRICANT
K091554 · NUC
Pharmapac, LLC
Obstetrics & Gynecology · 72d
Cleared Aug 07, 2009
CRYOPATCH SG PULMONARY HEMI-ARTERY
K091626 · DXZ
Cryolife, Inc.
Cardiovascular · 65d