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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
87433–87456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1998
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT...
K983278 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 69d
Cleared Nov 25, 1998
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K983291 · MRC
Ciba Vision Corporation
Ophthalmic · 65d
Cleared Nov 25, 1998
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
K983301 · JWY
Accumed Intl., Inc.
Microbiology · 65d
Cleared Nov 25, 1998
DCI ENDOSCOPE
K983384 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 61d
Cleared Nov 25, 1998
BIOSTREP A-DIRECT STREP A ANTIGEN TEST
K983386 · GTY
Princeton BioMeditech Corp.
Microbiology · 60d
Cleared Nov 25, 1998
HOFFMANN II MIAMI POST
K983419 · HRS
Howmedica Corp.
Orthopedic · 57d
Cleared Nov 25, 1998
ABBOTT ARCHITECT TOTAL T4
K983440 · KLI
Abbott Laboratories
Chemistry · 57d
Cleared Nov 25, 1998
PRECISET SERUM PROTEINS CALIBRATOR
K983469 · JIX
Boehringer Mannheim Corp.
Chemistry · 55d
Cleared Nov 25, 1998
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K983726 · LCP
Genzyme Corp.
Chemistry · 34d
Cleared Nov 25, 1998
AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O...
K983788 · GEI
Aaron Medical Industries
General & Plastic Surgery · 29d
Cleared Nov 25, 1998
SPECTRUM SMALL FRY
K983859 · IOR
Freedom Designs, Inc.
Physical Medicine · 30d
Cleared Nov 25, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
K983895 · JZG
Beckman Coulter, Inc.
Immunology · 22d
Cleared Nov 25, 1998
ARTHRO-SURGIMAT-1500
K983910 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 22d
Cleared Nov 25, 1998
MODIFICATION TO BIO-LOGIC SLEEPSCAN
K983913 · OLV
Bio-Logic Systems Corp.
Neurology · 21d
Cleared Nov 25, 1998
DORNIER MEDILA H
K983963 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 19d
Cleared Nov 25, 1998
IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
K983970 · DDR
Diagnostic Products Corp.
Chemistry · 16d
Cleared Nov 25, 1998
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
K984070 · JJX
Bio-Rad
Chemistry · 9d
Cleared Nov 25, 1998
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
K984073 · JJX
Bio-Rad
Chemistry · 9d
Cleared Nov 24, 1998
ERCO-RIBBON
K981343 · LKY
Ercons, Inc.
Gastroenterology & Urology · 225d
Cleared Nov 24, 1998
ERCO-VAC
K981357 · LKY
Ercons, Inc.
Gastroenterology & Urology · 224d
Cleared Nov 24, 1998
BAXTER HEMOSTASIS VALVE INTRODUCERS
K981909 · DYB
Baxter Edwards
Cardiovascular · 176d
Cleared Nov 24, 1998
SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX...
K982416 · LYY
Shun Thai Rubber Gloves Industry Co.,...
General Hospital · 134d
Cleared Nov 24, 1998
PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE
K982536 · JAK
Siemens Corp.
Radiology · 126d
Cleared Nov 24, 1998
MICROMEDICS NASAL SEPTAL BUTTON
K982667 · LFB
Micromedics, Inc.
Ear, Nose, Throat · 116d