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
146953–146976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1985
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
K850884 · FOS
Sherwood Medical Co.
General Hospital · 227d
Cleared Oct 17, 1985
GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX
K851486 · DRS
Gould, Inc.
Cardiovascular · 185d
Cleared Oct 17, 1985
VIAL VENT FILTER
K852467 · LHI
Baxter Healthcare Corp
General Hospital · 129d
Cleared Oct 17, 1985
E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY
K852535 · KNT
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 125d
Cleared Oct 17, 1985
COONS GASTROSTICK SYSTEM
K852552 · KNT
Medi-Tech, Inc.
Gastroenterology & Urology · 122d
Cleared Oct 17, 1985
LABORIE URODYNAMICS PROCESSOR
K852856 · FAP
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 104d
Cleared Oct 17, 1985
VIROGEN HERPES SLIDE TEST
K852928 · GQO
Armkel, LLC
Microbiology · 100d
Cleared Oct 17, 1985
SARNS EVACUPLEGE CATHETER
K853128 · DWF
3M Health Care, Sarns
Cardiovascular · 83d
Cleared Oct 17, 1985
INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI
K853172 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 79d
Cleared Oct 17, 1985
AMERICAN DILATATION SYSTEM
K853274 · KNQ
American Endoscopy, Inc.
Gastroenterology & Urology · 73d
Cleared Oct 17, 1985
HUBOUT
K853287 · FPA
I M, Inc.
General Hospital · 73d
Cleared Oct 17, 1985
OHMEDA HEAT REFLECTING PATCH
K853351 · FMT
Ohmeda Medical
General Hospital · 66d
Cleared Oct 17, 1985
VELCRO FISTULA PRESSURE CLAMPS
K853536 · KXM
Cp Medical
Gastroenterology & Urology · 55d
Cleared Oct 17, 1985
JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL
K853701 · FOZ
Critikon Company, LLC
General Hospital · 43d
Cleared Oct 17, 1985
KAY PLUS ADULT DIAPER
K853740 · EYQ
Beghin_Say Intl., Inc.
Gastroenterology & Urology · 41d
Cleared Oct 17, 1985
TECHNA VISION, INC. ELECTRIC CHAIR
K853743 · HME
Techna Vision
Ophthalmic · 41d
Cleared Oct 17, 1985
TECHNA VISION, INC.ELECTRIC TABLE
K853744 · HRJ
Techna Vision
Ophthalmic · 41d
Cleared Oct 17, 1985
COBE REN NEW-D DISPENSING KIT
K853817 · LIF
Cobe Laboratories, Inc.
Gastroenterology & Urology · 35d
Cleared Oct 16, 1985
INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK
K850417 · LMD
Impact Systems Corp.
Radiology · 254d
Cleared Oct 16, 1985
NAIL SPLINT
K850803 · MQZ
Inro Medical Designs, Inc.
General & Plastic Surgery · 231d
Cleared Oct 16, 1985
VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY
K850895 · DHB
Ventrex Laboratories, Inc.
Immunology · 226d
Cleared Oct 16, 1985
DENTAL PORCELAIN-VARIOUS
K851733 · ELL
Excelco Intl., Inc.
Dental · 174d
Cleared Oct 16, 1985
HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT
K851976 · GMM
Si Sero-Immuno Diagnostics, Inc.
Microbiology · 162d
Cleared Oct 16, 1985
HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT
K851977 · GMM
Si Sero-Immuno Diagnostics, Inc.
Microbiology · 162d