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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
153745–153768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1984
SDI C-FLEX STERILE LIGHT HANDLE
K834239
Sterile Design, Inc.
General & Plastic Surgery · 141d
Cleared Apr 25, 1984
SDL-30
K834280 · IYO
Shimadzu Corp.
Radiology · 163d
Cleared Apr 25, 1984
MACH I ELECTROSURGERY HAND CONTROL
K834434 · GEI
Surgical Products Corp.
General & Plastic Surgery · 128d
Cleared Apr 25, 1984
O'NEIL OBSTETRIC CUP
K840008 · HDB
Go Medical Industries Pty. , Ltd.
Obstetrics & Gynecology · 112d
Cleared Apr 25, 1984
VILENE SURGICAL MASK 5505
K840090
Hall-Tech
General & Plastic Surgery · 106d
Cleared Apr 25, 1984
TUBE-BANDAGE FOR HUMAN DIGITS 200
K840107 · FQM
Zens Health Care Products
General Hospital · 106d
Cleared Apr 25, 1984
QTA PROCESSOR MODULE
K840138 · IYO
General Electric Co.
Radiology · 104d
Cleared Apr 25, 1984
MONITOR CO2 LASER SURGICAL SYSTEM
K840145 · HQF
Cooper Lasersonics, Inc.
Ophthalmic · 103d
Cleared Apr 25, 1984
SINGLE LUMEN SUBCLAVIAN CANNULA
K840197 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 98d
Cleared Apr 25, 1984
PRESSURE SENTRY TOURNIQUET
K840206 · KCY
Richards Medical Co., Inc.
General & Plastic Surgery · 97d
Cleared Apr 25, 1984
DIAMOND LUSTRE
K840254 · EJR
Jelrus Technical Products Corp.
Dental · 93d
Cleared Apr 25, 1984
SILICONE SUCTION & IRRIGATION DRAIN
K840323 · GBX
Superior Plastic Products Corp.
General & Plastic Surgery · 91d
Cleared Apr 25, 1984
SILICONE SUMP DRAIN 20 & 40 FRENCH
K840324 · JCY
Superior Plastic Products Corp.
General & Plastic Surgery · 91d
Cleared Apr 25, 1984
LINEAR ARRAY TRANSDUCER OR SCANHEAD
K840408 · IYO
Adr Ultrasound
Radiology · 85d
Cleared Apr 25, 1984
REPLACE-A-TIP HIGH TEMP. CAUTERY
K840433 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 84d
Cleared Apr 25, 1984
REPLACE-A-TIP LOW TEMP. CAUTERY
K840434 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 84d
Cleared Apr 25, 1984
TOTAL BILIRUBIN REAGENT
K840486 · CIG
Somas Medical Industries, Inc.
Chemistry · 79d
Cleared Apr 25, 1984
SHUTT PRECISION PROBES
K840558 · HXB
Concept, Inc.
Orthopedic · 77d
Cleared Apr 25, 1984
DENTAL HANDPIECE
K840690 · EFB
Pen-Med Technology, Inc.
Dental · 69d
Cleared Apr 25, 1984
PERIO PIK
K840721 · EFS
Teledyne, Inc.
Dental · 68d
Cleared Apr 25, 1984
DIA-H 1/2/3 & DIA-HT 1/2/3
K840801
Diatech, Inc.
Hematology · 62d
Cleared Apr 25, 1984
DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
K840817 · KPJ
Hospitak, Inc.
General & Plastic Surgery · 61d
Cleared Apr 25, 1984
SECURLINE SURGICAL SKIN MARKER 1000
K840820 · FZZ
Precision Dynamics Corp.
General & Plastic Surgery · 61d
Cleared Apr 25, 1984
MODULAR CONSTRUCT FRAME EXTERNAL FIXA
K840856 · JEC
Precision Medical Devices, Inc.
Orthopedic · 61d