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
65761–65784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2005
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET,...
K050713 · DCN
Good Biotech Corp.
Chemistry · 80d
Cleared Jun 06, 2005
AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K050776 · LFL
Misonix, Inc.
General & Plastic Surgery · 70d
Cleared Jun 06, 2005
SPOTCHEM II LDH TEST
K050790 · CFH
Arkray, Inc.
Chemistry · 70d
Cleared Jun 06, 2005
KOO AMERICAS VALVE PEEP, MODEL KM-809
K050918 · BYE
Koo Americas, Inc.
Anesthesiology · 55d
Cleared Jun 06, 2005
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K051043 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 42d
Cleared Jun 06, 2005
MAS IMMUNOSUPPRESSANT CONTROLS
K051074 · LAS
Microgenics Corp.
Toxicology · 40d
Cleared Jun 06, 2005
NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE
K051094 · KGO
Terang Nusa Sdn Bhd
General Hospital · 39d
Cleared Jun 03, 2005
REPROCESSED TROCARS
K033591 · KBG
Clearmedical, Inc.
Ear, Nose, Throat · 568d
Cleared Jun 03, 2005
WAGNER STERISET STERILIZATION CONTAINER
K041096 · FRG
Wagner GmbH
General Hospital · 402d
Cleared Jun 03, 2005
TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K041511 · GAW
Sutures India Private Limited
General & Plastic Surgery · 361d
Cleared Jun 03, 2005
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
K041514 · GAP
Sutures India Private Limited
General & Plastic Surgery · 361d
Cleared Jun 03, 2005
HEMCON BANDAGE AND HEMCON BANDAGE OTC
K043050 · QSY
Hemcon, Inc.
General & Plastic Surgery · 211d
Cleared Jun 03, 2005
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000
K043574 · FKT
Renal Solutions, Inc.
Gastroenterology & Urology · 158d
Cleared Jun 03, 2005
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
K050008 · EZD
Mentor Corp.
Gastroenterology & Urology · 151d
Cleared Jun 03, 2005
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
K050599 · DQY
Boston Scientific Corp
Cardiovascular · 86d
Cleared Jun 03, 2005
COOL.CLICK
K050734 · KZE
Bioject, Inc.
General Hospital · 74d
Cleared Jun 03, 2005
IMBIBE BONE MARROW ASPIRATION NEEDLE
K050795 · KNW
Orthovita, Inc.
Gastroenterology & Urology · 66d
Cleared Jun 03, 2005
RIVA LIGHT CURE
K050870 · EMA
Southern Dental Industries, Inc.
Dental · 58d
Cleared Jun 03, 2005
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG
K050885 · LFL
Olympus Medical Systems Corporation
General & Plastic Surgery · 57d
Cleared Jun 03, 2005
CALLOS IMPACT AND INJECT BONE VOID FILLER
K051123 · MQV
Skeletal Kinetics, LLC
Orthopedic · 31d
Cleared Jun 03, 2005
KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0
K051127 · LLZ
Kika Medical, Inc.
Radiology · 31d
Cleared Jun 03, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML
K051138 · LON
Becton, Dickinson & CO
Microbiology · 30d
Cleared Jun 03, 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051152 · LYZ
Zibo Sinocare Plastic Products Co., Ltd.
General Hospital · 30d
Cleared Jun 03, 2005
ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM
K051304 · IYO
Science Surgical Corporation
Radiology · 15d