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
166153–166176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1980
VIRAL TRANSPORT MED. (46-995-04)
K802303 · JSM
Flow Laboratories, Inc.
Microbiology · 38d
Cleared Oct 31, 1980
COMFORT CUSHION DRY BURN PADS, STERILE
K802317 · KKX
American Convertors Div., American...
General Hospital · 38d
Cleared Oct 31, 1980
COULTER DACOS SERUM CHEM. ANALYZER
K802320 · JJE
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Oct 31, 1980
PHADEBACT PNEUMOCOCCUS TEST
K802337 · GWC
Pharmacia, Inc.
Microbiology · 35d
Cleared Oct 31, 1980
DISP. FENESTRATED SURG. DRAPE SHEETS
K802359 · KKX
American Convertors Div., American...
General Hospital · 35d
Cleared Oct 31, 1980
UTERINE VACUM ASPIRATING CURRETTE
K802360 · HHI
American Hospital Supply Corp.
Obstetrics & Gynecology · 35d
Cleared Oct 31, 1980
MOTI PROTECTIVE X-RAY MASK
K802377 · KPY
Moti Enterprises, Inc.
Radiology · 31d
Cleared Oct 31, 1980
HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER
K802379 · LCH
American Instrument Co.
Chemistry · 31d
Cleared Oct 31, 1980
ARIA II 125 I CORTISOL
K802380 · CGR
Bd Becton Dickinson Vacutainer...
Chemistry · 30d
Cleared Oct 31, 1980
ELECTROLY TE CHEMISTRY ANALYZER
K802398 · JJF
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Oct 31, 1980
PACEMAKER LEAD ADAPTOR MODEL 431
K802407 · DTD
Pacesetter Systems
Cardiovascular · 28d
Cleared Oct 31, 1980
MICROTHIN-DI BIPOLAR PULSE GENERATOR
K802409 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 28d
Cleared Oct 31, 1980
MICROTHIN-PI BIPOLAR PULSE GENERATOR
K802410 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 28d
Cleared Oct 31, 1980
BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT
K802415 · JSG
Remel Co.
Microbiology · 25d
Cleared Oct 31, 1980
FETAL BOVINE SERUM
K802418 · KIS
S&S Biologicals
Hematology · 25d
Cleared Oct 31, 1980
CENTRIFICHEM INORGANIC PHOSPHORUS
K802420 · CED
Union Carbide Corp.
Chemistry · 25d
Cleared Oct 31, 1980
OSTOMATE THIRD HAND
K802424 · EXB
Smith'S Ostomy Products, Inc.
Gastroenterology & Urology · 25d
Cleared Oct 31, 1980
LA-SPORO ANTIBODY SYSTEM
K802427 · GMA
Immuno-Mycologics, Inc.
Microbiology · 25d
Cleared Oct 31, 1980
BARD MALE EXTERNAL CATHETER
K802433 · KNX
C.R. Bard, Inc.
Gastroenterology & Urology · 25d
Cleared Oct 31, 1980
CENTRIFICHEM ALBUMIN
K802436 · CIX
Union Carbide Corp.
Chemistry · 25d
Cleared Oct 31, 1980
LOW BACK POSTURE PILLOW
K802442 · IQK
Body Therapeutics, Inc.
Physical Medicine · 24d
Cleared Oct 31, 1980
RANAWAT ESF TOTAL CONDYLAR KNEE
K802446 · HRY
Howmedica Corp.
Orthopedic · 24d
Cleared Oct 31, 1980
GESTATE SLIDE EIKEN KIT AGG. METHOD HUM
K802450 · JHJ
Syn-Kit, Inc.
Chemistry · 23d
Cleared Oct 31, 1980
ESTRIOL-SQUIBB RIA KIT
K802455 · CGI
E. R. Squibb & Sons, Inc.
Chemistry · 23d