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
142753–142776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1986
LACTATE DEHYDROGENASE(LD) PROCEDURE
K863255 · CFJ
Data Medical Associates, Inc.
Chemistry · 39d
Cleared Oct 03, 1986
MODIFIED FOLEY CATHETER
K863302 · KOD
Sheridan Catheter Corp.
Gastroenterology & Urology · 39d
Cleared Oct 03, 1986
HEMOLYSE
K863503 · GGK
Reagent Laboratory, Inc.
Hematology · 24d
Cleared Oct 03, 1986
MODIFIED MEDI-QUET TOURNIQUET, MODEL #2740-00
K863551
Depuy, Inc.
General & Plastic Surgery · 21d
Cleared Oct 03, 1986
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K863586 · JPZ
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Oct 03, 1986
CREATINE PHOSPHOKINASE(CK) PROCEDURE
K863587 · CGS
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Oct 03, 1986
DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE
K863604
American Edwards Laboratories
General & Plastic Surgery · 17d
Cleared Oct 03, 1986
ARTHROSCOPIC IRRIGATION PUMP
K863605 · HRX
American Edwards Laboratories
Orthopedic · 17d
Cleared Oct 03, 1986
TDX(R) AMYLASE II
K863622 · JFJ
Abbott Laboratories
Chemistry · 17d
Cleared Oct 03, 1986
PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5
K863671 · KNX
Samco Industries, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 03, 1986
CORNING ELISA PLATES
K863789 · LIB
Corning Medical & Scientific
Chemistry · 7d
Cleared Oct 02, 1986
MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)
K860831 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 211d
Cleared Oct 02, 1986
T-FASTENER
K861599 · KNT
Medi-Tech, Inc.
Gastroenterology & Urology · 156d
Cleared Oct 02, 1986
MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
K862422 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 99d
Cleared Oct 02, 1986
SWIVEL COUPLER
K863205 · BYJ
Venmill Swivel, Co.
Anesthesiology · 44d
Cleared Oct 02, 1986
CREATININE PROCEDURE
K863261 · CGX
Data Medical Associates, Inc.
Chemistry · 38d
Cleared Oct 02, 1986
DISPOSABLE PNEUMOPERITONEUM NEEDLE
K863330 · FHO
United States Surgical, A Division of...
Gastroenterology & Urology · 44d
Cleared Oct 02, 1986
MODEL MC-1 SURGICAL VIDEO CAMERA
K863376 · FWF
Biometric Products, Inc.
General & Plastic Surgery · 29d
Cleared Oct 02, 1986
BIPOL CABLE
K863412 · GEI
Treace Medical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 02, 1986
BIPOLFORCEPS
K863413 · GEI
Treace Medical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 02, 1986
TAMPAX SUPER TAMPONS
K863464 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 24d
Cleared Oct 02, 1986
COLORADO MEDICAL MODEL PTC 1000
K863471 · KXM
Colorado Medical, Inc.
Gastroenterology & Urology · 23d
Cleared Oct 02, 1986
WEINGART MODEL 1000 SUNLAMP PRODUCT
K863518 · FTC
Weingart, Inc.
General & Plastic Surgery · 23d
Cleared Oct 02, 1986
POTASSIUM HYDROXIDE 10% W/V
K863550 · PPM
Reagent Laboratory, Inc.
Chemistry · 20d