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
144361–144384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1986
IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES
K861545 · HMX
Rophae Lens Co., Inc.
Ophthalmic · 34d
Cleared May 28, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE
K861574 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared May 28, 1986
SCHNEIDER-SHILEY PRESSURE MANOMETER
K861605 · KRK
Shiley, Inc.
Cardiovascular · 29d
Cleared May 28, 1986
STORZ E9050 & E9055 DIAMOND KNIVES
K861732 · HNN
Storz Instrument Co.
Ophthalmic · 22d
Cleared May 27, 1986
ASSERT EO BIOLOGICAL TEST PACK
K854631 · FRC
Surgicot, Inc.
General Hospital · 190d
Cleared May 27, 1986
CONVEX PROBE, PVE-382M
K860281 · ITX
Toshiba Medical Systems
Radiology · 119d
Cleared May 27, 1986
DIASONICS 3.5 GWA 30MM PROBE
K860361 · ITX
Diasonics, Inc.
Radiology · 117d
Cleared May 27, 1986
SOF SET, MODELS 113 AND 114
K860857 · FRN
Pacesetter Systems
General Hospital · 81d
Cleared May 27, 1986
R1124 & R1686 PARAFFIN
K861344 · IMC
Tri W-G, Inc.
Physical Medicine · 50d
Cleared May 27, 1986
STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA
K861496 · DWF
Shiley, Inc.
Cardiovascular · 35d
Cleared May 27, 1986
UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F)
K861518 · FPA
Jufrey Multimed Corp.
General Hospital · 34d
Cleared May 27, 1986
UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330F)
K861519 · FPA
Jufrey Multimed Corp.
General Hospital · 34d
Cleared May 27, 1986
UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205)
K861520 · FPA
Jufrey Multimed Corp.
General Hospital · 34d
Cleared May 27, 1986
UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330)
K861521 · FPA
Jufrey Multimed Corp.
General Hospital · 34d
Cleared May 27, 1986
STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025)
K861523 · BRZ
Jufrey Multimed Corp.
General Hospital · 34d
Cleared May 27, 1986
SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER
K861622 · IKK
Orthopedic Systems, Inc.
Physical Medicine · 28d
Cleared May 27, 1986
SIMS CHAIR
K861632 · IKK
Twin City Surgical, Inc.
Physical Medicine · 28d
Cleared May 27, 1986
MAGNESIUM PROCEDURE
K861668 · JGJ
Data Medical Associates, Inc.
Chemistry · 27d
Cleared May 27, 1986
SODIUM, POTASSIUM AND CHLORIDE PROCEDURE
K861669 · CGZ
Data Medical Associates, Inc.
Chemistry · 27d
Cleared May 27, 1986
RIONET HEARING AID
K861728 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared May 27, 1986
SPRINT (POWER DRIVE WHEELCHAIR)
K861729 · ITI
Everest & Jennings, Inc.
Physical Medicine · 21d
Cleared May 27, 1986
THERACUSHION MODEL 1000
K861834 · ISA
General Physiotherapy, Inc.
Physical Medicine · 14d
Cleared May 23, 1986
TRANSVAGINAL TRANSDUCER, 5MHZ
K860234 · HGL
Philips Medical Systems, Inc.
Obstetrics & Gynecology · 121d
Cleared May 23, 1986
BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
K860719 · JPA
Biotrack, Inc.
Hematology · 86d