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
150769–150792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1984
PACE *AID MODEL 52
K843547 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 98d
Cleared Dec 17, 1984
QCA HEMOGLOBIN KIT
K843695 · KRZ
Bd Becton Dickinson Vacutainer...
Hematology · 89d
Cleared Dec 17, 1984
CLOSED URINARY DRAINAGE UNIT
K843698 · KNX
Pathfinder Intl. Corp.
Gastroenterology & Urology · 88d
Cleared Dec 17, 1984
NUCLEAR 700 MEDICINE MECHANICAL POSIT-
K843716 · IYX
Technicare Corp.
Radiology · 84d
Cleared Dec 17, 1984
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
K843805 · JPK
Coulter Electronics, Inc.
Hematology · 81d
Cleared Dec 17, 1984
COROMETRICS FETAL MONITOR 142
K843918 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 73d
Cleared Dec 17, 1984
PRESTILIX 1690
K843926 · IXR
Cgr Medical Corp.
Radiology · 51d
Cleared Dec 17, 1984
CT 9000
K843927 · JAK
General Electric Co.
Radiology · 73d
Cleared Dec 17, 1984
COUNTERBALANCED VERTICAL CASSETTE HOLDER
K843928 · IYB
Poersch Metal Mfg. Co.
Radiology · 73d
Cleared Dec 17, 1984
CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE
K844015 · GWS
Cns, Inc.
Neurology · 66d
Cleared Dec 17, 1984
CLAMP, TUBING, LINE
K844121 · FKK
Dyn-A-Med Products
Gastroenterology & Urology · 55d
Cleared Dec 17, 1984
VENTIBOX
K844160 · KPY
Syncor Intl. Corp.
Radiology · 54d
Cleared Dec 17, 1984
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
K844280 · KNX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 42d
Cleared Dec 17, 1984
SCRUB MATE DRY STERILE SCRUB BRUSH
K844411 · GEC
American Sterilizer Co.
General & Plastic Surgery · 33d
Cleared Dec 17, 1984
APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE
K844417 · GAG
Davis & Geck, Inc.
General & Plastic Surgery · 32d
Cleared Dec 17, 1984
MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR
K844420 · BTM
Med-Life, Inc.
Anesthesiology · 32d
Cleared Dec 17, 1984
MEDIPART XENON BREATHING KIT MP-02XM
K844495 · IYT
Medipart Jerry Alexander
Radiology · 27d
Cleared Dec 17, 1984
ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE
K844557 · BSR
Ackrad Laboratories
Anesthesiology · 26d
Cleared Dec 17, 1984
ACUTE HEMODIALYSIS TRAYS
K844612 · KNZ
Packaging Technologies, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 17, 1984
TUBING HOLDER
K844757
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 10d
Cleared Dec 14, 1984
STAPLE REMOVER SR300P
K833085 · GDT
Prosper, Inc.
General & Plastic Surgery · 459d
Cleared Dec 14, 1984
MYOPULSE
K833928 · IPF
Biomedical Design Instruments
Physical Medicine · 396d
Cleared Dec 14, 1984
BIPOLAR SUCTION ELECTRODE
K843498 · GET
Eder Instrument Co, Inc.
General & Plastic Surgery · 99d
Cleared Dec 14, 1984
MONTGOMERY SAFE-T-TUBE
K843936 · BTR
Boston Medical Products, Inc.
Anesthesiology · 66d