FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
165313–165336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 31, 1980
T4-SQUIBB RIA KIT
K802456 · CDX
E. R. Squibb & Sons, Inc.
Chemistry · 23d
Cleared Oct 31, 1980
ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
K802461 · LCW
Immunotech Corp.
Immunology · 23d
Cleared Oct 31, 1980
MICRO-SURGICAL POWER INSTRUMENT SYSTEM
K802463 · ERL
Spire Medical, Inc.
Ear, Nose, Throat · 22d
Cleared Oct 31, 1980
OREAI-Q-TU TEST
K802464 · KHQ
Organon, Inc.
Chemistry · 22d
Cleared Oct 31, 1980
TSH RADIOIMMUNOASSAY KIT
K802467 · JLW
American Diagnostic Corp.
Chemistry · 22d
Cleared Oct 31, 1980
T3 UPTAKE TEST SYSTEM
K802468 · KHQ
American Diagnostic Corp.
Chemistry · 22d