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
142585–142608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1986
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
K864040 · FAE
C.R. Bard, Inc.
Gastroenterology & Urology · 8d
Cleared Oct 23, 1986
AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849
K852502 · IYO
Bruel & Kjaer Industri A/S
Radiology · 498d
Cleared Oct 23, 1986
SULKY SPECIAL
K863450 · LBE
Asc Corp.
Physical Medicine · 50d
Cleared Oct 23, 1986
UNIVERSAL CANNULA SYSTEM
K863590 · HRX
Aspen Laboratories, Inc.
Orthopedic · 38d
Cleared Oct 23, 1986
RE-HEATER, HOT PACK
K863654 · IME
K & L Ent.
Physical Medicine · 35d
Cleared Oct 23, 1986
SURGICAL DRAPE & DRAPE ACCESSORIES
K863732 · KKX
Intera Corp.
General Hospital · 30d
Cleared Oct 23, 1986
PULSESTAR EXERCISE BIKE
K863884 · ISD
Battle Creek Equipment Co.
Physical Medicine · 17d
Cleared Oct 23, 1986
THERACARE LOUNGER
K863892 · IOR
American Theracare
Physical Medicine · 17d
Cleared Oct 22, 1986
SUCTION CATHETER KIT
K861949 · BSY
Medi-Craft , Ltd.
Anesthesiology · 155d
Cleared Oct 22, 1986
DOUBLE LUMEN E T ADAPTOR
K862435 · BZA
Acutronic Medical Systems AG
Anesthesiology · 118d
Cleared Oct 22, 1986
STARCRAFT ELITE AUTOCLAVE
K862495 · FLE
Starcraft Medical Corp.
General Hospital · 113d
Cleared Oct 22, 1986
TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER
K862548 · BZT
Lawrence Medical Systems, Inc.
Anesthesiology · 111d
Cleared Oct 22, 1986
ASSERACHROM B-TG KIT
K862775 · JBX
American Bioproducts Co.
Hematology · 92d
Cleared Oct 22, 1986
PATHFINDER ROTAVIRUS CHEMILUMINESCENT
K862917 · LIQ
Kallestad Laboratories, Inc.
Microbiology · 82d
Cleared Oct 22, 1986
MEDI-PLAST DISPOSABLE MANIFOLD
K863402 · DTL
Medi-Plast Intl., Inc.
Cardiovascular · 49d
Cleared Oct 22, 1986
OBSTETRICAL KIT
K863504
Dyna-Med
Obstetrics & Gynecology · 43d
Cleared Oct 22, 1986
OXY-OFF(TM)
K863510 · BXY
B&B Medical Technologies, Inc.
Anesthesiology · 43d
Cleared Oct 22, 1986
I.V. START KIT, STERILE, DISPOSABLES
K863712 · LRS
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 29d
Cleared Oct 21, 1986
SOLUTION B- NA 50MEQ/L, K 40 MEQ/L
K863502 · JIX
Reagent Laboratory, Inc.
Chemistry · 42d
Cleared Oct 21, 1986
ULTRAWASH I
K863623 · JQW
Dynatech Laboratories, Inc.
Chemistry · 35d
Cleared Oct 21, 1986
ULTRAWASH II
K863624 · JQW
Dynatech Laboratories, Inc.
Chemistry · 35d
Cleared Oct 20, 1986
TECHNICON RA-XT SYSTEM WITH ANALYTES
K862561 · JJC
Technicon Instruments Corp.
Chemistry · 109d
Cleared Oct 20, 1986
SYNECTICS MOTILITY SYSTEM
K862929 · FFT
Synectics-Dantec
Gastroenterology & Urology · 89d
Cleared Oct 20, 1986
MEDITRADE ARTIFICIAL EYES AND IMPLANTS
K862977 · HPZ
Meditrade, Inc.
Ophthalmic · 74d