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
155521–155544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1983
ABBOTT GLOBE HOLDER
K832911 · HJO
Miami Eye Technology, Inc.
Ophthalmic · 31d
Cleared Sep 29, 1983
RISTOCETIN PLATELET AGGREGA-REAGENT TEST
K832929 · JBX
Sigma Chemical Co.
Chemistry · 36d
Cleared Sep 29, 1983
SPINNER SALT SOLUTION S-6011 W/EARLES
K832930 · KIT
Sigma Chemical Co.
Chemistry · 36d
Cleared Sep 29, 1983
MACCONKEY'S AGAR PLATE
K832934
Otisville Biotech, Inc.
Microbiology · 30d
Cleared Sep 29, 1983
ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO
K832947 · KIR
Ortho Diagnostic Systems, Inc.
Pathology · 29d
Cleared Sep 29, 1983
NYC-GC MEDIA
K832948 · JTY
Otisville Biotech, Inc.
Microbiology · 30d
Cleared Sep 29, 1983
MUCICARMINE STAIN, #HT30
K832953 · HZC
Sigma Chemical Co.
Chemistry · 29d
Cleared Sep 29, 1983
V AGAR
K832954 · JSI
Bd Becton Dickinson Vacutainer...
Microbiology · 29d
Cleared Sep 29, 1983
BACTEROIDES BILE ESCULIN AGAR
K832955 · JSI
Bd Becton Dickinson Vacutainer...
Microbiology · 29d
Cleared Sep 29, 1983
FLOW-DIRECTED HEPARIN COATED THERMODIL
K832957 · DYG
Sorensen Research
Cardiovascular · 29d
Cleared Sep 29, 1983
PEDAL EXERCISER
K832968 · ION
Maddak, Inc.
Physical Medicine · 28d
Cleared Sep 29, 1983
WALKING CANE
K832969 · IPS
Maddak, Inc.
Physical Medicine · 28d
Cleared Sep 29, 1983
CANE REACHER
K832970 · IPS
Maddak, Inc.
Physical Medicine · 28d
Cleared Sep 29, 1983
MIDAS 6000 AUTOMATIC STAINER
K832994 · KPA
Innovative Medical Systems, Inc.
Hematology · 27d
Cleared Sep 26, 1983
SUPERJET BTD BLEEDING TIME DEVICE DISP
K830001 · FMK
Medprobe Laboratories
Hematology · 266d
Cleared Sep 26, 1983
APNEA ALARM FOR ADULT-PEDIATRIC & NEON
K831601 · BZQ
Plasmedics, Inc.
Anesthesiology · 131d
Cleared Sep 26, 1983
TISSUE FORCEPS
K831663 · KOC
Medcare Products
Gastroenterology & Urology · 126d
Cleared Sep 26, 1983
DRAVON T CLAMP
K831842 · KDC
Dravon Medical, Inc.
General & Plastic Surgery · 110d
Cleared Sep 26, 1983
BREATHING CIRCUIT BACTERIA FILTER
K831856 · CAH
Vital Signs, Inc.
General Hospital · 109d
Cleared Sep 26, 1983
BACTIGEN S. PNEUMONIAE
K831887 · GWC
Armkel, LLC
Microbiology · 105d
Cleared Sep 26, 1983
COLOR-EZE PRE-WASHED LAP SPONGES
K831913 · GDY
Ormed Mfg., Inc.
General & Plastic Surgery · 104d
Cleared Sep 26, 1983
VILENE COTTON GAUZE II
K831917 · EFQ
Hall-Tech
General & Plastic Surgery · 104d
Cleared Sep 26, 1983
TOXO-SCREEN DA TEST
K831930 · LLA
Bd Becton Dickinson Vacutainer...
Immunology · 103d
Cleared Sep 26, 1983
DIRECTIGEN GROUP B STREP TEST KIT-SERUM
K831991 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 97d