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
157033–157056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1983
EXTERNAL INCONTINENCE CATHETER TRAVEL
K832106 · KNX
Plasco, Inc.
Gastroenterology & Urology · 20d
Cleared Jul 19, 1983
LEG BAG EXTENTION TUBE-STERILE
K832107 · KNX
Plasco, Inc.
Gastroenterology & Urology · 20d
Cleared Jul 19, 1983
MONOBLOCK PROSTOPERATIVE TENS ELECTRODE
K832145 · GXY
New Dimensions IN Medicine, Inc.
Neurology · 14d
Cleared Jul 18, 1983
WEDGE PRESSURE CATHETER
K830604 · DYG
Plasmedics, Inc.
Cardiovascular · 143d
Cleared Jul 18, 1983
APNEA/BRADYCARDIA MONITOR HB 95
K830666 · DPS
Harvey-Bostwick, Inc.
Cardiovascular · 136d
Cleared Jul 18, 1983
HSV IGM TEST
K830865 · GQL
Gull Laboratories, Inc.
Microbiology · 122d
Cleared Jul 18, 1983
OMNIPROBE ELECTRICAL NERVE STIMULATOR
K831147 · GZJ
Omni Intl., Inc.
Neurology · 101d
Cleared Jul 18, 1983
ARTHROSCOPY INFUSION SYS..VALVE
K831218 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 94d
Cleared Jul 18, 1983
ANTI-ENA TEST
K831292 · LKO
Meloy Laboratories, Inc.
Immunology · 89d
Cleared Jul 18, 1983
MSI-NAK-50 TEST KIT
K831300 · JGM
Medical Specialties, Inc.
Chemistry · 88d
Cleared Jul 18, 1983
DIFFERENTIA/DIAGNOSTIC OCCLUSA/APPLIANC
K831344
Brimms, Inc.
Dental · 84d
Cleared Jul 18, 1983
CELL-DYN 400 HEMOTOLOGY ANALYZER
K831368 · GKL
Abbott Diagnostics
Hematology · 83d
Cleared Jul 18, 1983
CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO
K831495 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 69d
Cleared Jul 18, 1983
NEPHROLYTE
K831502 · KFC
Flaitron Laboratories, Inc.
Pathology · 68d
Cleared Jul 18, 1983
SPINAL FLUID TOTAL PROTEIN CONTROL
K831527 · JJX
Quantimetrix Corp.
Chemistry · 67d
Cleared Jul 18, 1983
FLUORETS STERILE OPHTH. STRIPS
K831621 · KYC
Smith & Nephew, Inc.
Ophthalmic · 60d
Cleared Jul 18, 1983
WAKO R-GTP C-TEST
K831639 · JPZ
Wako Chemicals USA, Inc.
Chemistry · 56d
Cleared Jul 18, 1983
HYPER-HYPOTHERMIA UNIT HYPO 10-200
K831677 · DWC
Gambro, Inc.
Cardiovascular · 56d
Cleared Jul 18, 1983
WAKO CHOLESTEROL CII
K831687 · CHH
Wako Chemicals USA, Inc.
Pathology · 55d
Cleared Jul 18, 1983
WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD
K831705 · DTZ
C.R. Bard, Inc.
Cardiovascular · 53d
Cleared Jul 18, 1983
MONOJET SPS BLOOD COLLECTION TUBE
K831719 · JKA
Sherwood Medical Co.
Chemistry · 48d
Cleared Jul 18, 1983
PERCUTANEOUS CATHETER INSERTION TRAY
K831729 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 48d
Cleared Jul 18, 1983
CONTINUOUS FLUSH DEVICE
K831730 · KRA
American Pharmaseal Div. Ahsc
Cardiovascular · 48d
Cleared Jul 18, 1983
INFANT EVALUATION CARRIER
K831731 · FPP
E.M. Adams
General Hospital · 48d