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
137137–137160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1988
FRESENIUS HEMOFLOW F3, F4, F5, F7
K874872 · FJI
Seratronics, Inc.
Gastroenterology & Urology · 84d
Cleared Feb 19, 1988
ACUSON TRANSPERINEAL NEEDLE GUIDE
K874922 · ITX
Acuson Computed Sonography
Radiology · 78d
Cleared Feb 19, 1988
CEMENT LINER
K874945 · EMA
Dentsply Intl.
Dental · 77d
Cleared Feb 19, 1988
STERILE SCRUBBY SCRUB BRUSH
K875033 · GEC
Medsurg Industries, Inc.
General & Plastic Surgery · 74d
Cleared Feb 19, 1988
PEYMAN G. 12.12 YAG LASER LENS
K875087 · HJK
Ocular Instruments, Inc.
Ophthalmic · 72d
Cleared Feb 19, 1988
HOSKINS-BARKAN GONIOTOMY LENS 9MM
K875114 · HJK
Ocular Instruments, Inc.
Ophthalmic · 67d
Cleared Feb 19, 1988
AMICON EQUALINE FLUID BALANCE SYSTEM
K875121 · KPF
Amicon, Inc.
Gastroenterology & Urology · 66d
Cleared Feb 19, 1988
LOW-POWER BINOCULAR LOUPE
K875124 · HOH
Seiler Instrument & Mfg. Co., Inc.
Ophthalmic · 66d
Cleared Feb 19, 1988
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
K875214 · LJT
Therex Corp.
General Hospital · 63d
Cleared Feb 19, 1988
UFR DIGITAL RETROFIT
K875312 · FJB
Yankee Intl. Medical Research & Mfg.,...
Gastroenterology & Urology · 52d
Cleared Feb 19, 1988
GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS
K880084 · FJI
Gambro, Inc.
Gastroenterology & Urology · 38d
Cleared Feb 19, 1988
FACTOR VIII REFERENCE PLASMA
K880292 · GJT
Helena Laboratories
Hematology · 25d
Cleared Feb 19, 1988
SEA - PORT INFUSION SET
K880297 · LJT
Harbor Medical Devices, Inc.
General Hospital · 25d
Cleared Feb 19, 1988
CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER
K880302 · GGN
Hemotec, Inc.
Hematology · 25d
Cleared Feb 19, 1988
MARLEN ULTRA ILEOSTOMY POUCH-5000
K880327 · EZQ
Marlen Mfg. & Development Co.
Gastroenterology & Urology · 24d
Cleared Feb 19, 1988
KIMBERLY-CLARK PROFESSIONAL JACKET
K880385 · FME
Kimberly-Clark Corp.
General Hospital · 22d
Cleared Feb 19, 1988
TRACK AND CARRIER, INTRAVENOUS
K880538 · FOX
Ferguson Medical
General Hospital · 10d
Cleared Feb 18, 1988
COXA ACETABULAR CUP
K871852 · JDI
Thackray USA
Orthopedic · 282d
Cleared Feb 18, 1988
PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM
K871912 · DPT
Electro-Diagnostic Instruments
Cardiovascular · 276d
Cleared Feb 18, 1988
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
K872632 · GQN
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 227d
Cleared Feb 18, 1988
GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN
K873032 · DXK
Biosound, Inc.
Cardiovascular · 198d
Cleared Feb 18, 1988
DSL ACTIVE ESTRADIOL RIA (DSL #4300)
K873550 · CHP
Diagnostic Systems Laboratories, Inc.
Chemistry · 171d
Cleared Feb 18, 1988
SERIES 77000 ULTRASOUND IMAGING SYSTEM
K873762 · DXK
Hewlett-Packard Co.
Cardiovascular · 155d
Cleared Feb 18, 1988
AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144
K874362 · KHQ
Amersham Corp.
Chemistry · 118d