FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
99745–99768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1996
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP
K950342 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 389d
Cleared Feb 20, 1996
MULTICHECK
K952725 · GLY
Radiometer America, Inc.
Chemistry · 251d
Cleared Feb 20, 1996
PRELOADED SOFT TISSUE ANCHOR
K953954 · MBI
Linvatec Corp.
Orthopedic · 182d
Cleared Feb 20, 1996
MEDLITE LASER SYSTEM
K955131 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 103d
Cleared Feb 20, 1996
CONSENSUS ZIRCONIA FEMORAL HEAD
K955386 · LZO
U.S. Medical Products, Inc.
Orthopedic · 90d
Cleared Feb 20, 1996
INTRAN PLUS
K955443 · HFN
Utah Medical Products, Inc.
Obstetrics & Gynecology · 84d
Cleared Feb 20, 1996
PRIME CEMENTED CALCAR FEMORAL STEMS
K955620 · JDI
Orthopaedic Innovations, Inc.
Orthopedic · 71d
Cleared Feb 20, 1996
4000 ETM
K960296 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 29d
Cleared Feb 16, 1996
TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
K942389 · HET
Hogan & Hartson
Obstetrics & Gynecology · 639d
Cleared Feb 16, 1996
UNIQUE NEEDLE WITH FIRM GRIP SHIELD
K950666 · FMF
Unique Management Ent., Inc.
General Hospital · 368d
Cleared Feb 16, 1996
NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
K952852 · FPA
Critical Device Corp.
General Hospital · 240d
Cleared Feb 16, 1996
CERALAS F ND:YAG LASER SYSTEM
K953851 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 184d
Cleared Feb 16, 1996
BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS
K954921 · MDB
Becton Dickinson Diagnostic...
Microbiology · 113d
Cleared Feb 16, 1996
BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS
K954925 · MDB
Becton Dickinson Diagnostic...
Microbiology · 113d
Cleared Feb 16, 1996
BACTEC PEDS PLUS/F CULTURE VIALS
K954927 · MDB
Becton Dickinson Diagnostic...
Microbiology · 113d
Cleared Feb 16, 1996
BACTEC CULTURE VIALS, LYTIC, ANAEROBIC
K954930 · MDB
Becton Dickinson Diagnostic...
Microbiology · 113d
Cleared Feb 16, 1996
GC BASE W/ 1% GCHI
K954986 · JTY
Remel, L.P.
Microbiology · 108d
Cleared Feb 16, 1996
OXYPULSE EOC I, EOC II & EOC R
K955129 · NFB
Eagle Medical Equipment Co.
Anesthesiology · 99d
Cleared Feb 16, 1996
WAKO AUTOKIT CRP NEW
K955156 · DCK
Wako Chemicals USA, Inc.
Immunology · 95d
Cleared Feb 16, 1996
ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS
K955277 · KOC
Baxter Healthcare Corp
Gastroenterology & Urology · 91d
Cleared Feb 16, 1996
ULTRAFLEX
K955347 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Feb 16, 1996
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348 · KWP
Depuy, Inc.
Orthopedic · 87d
Cleared Feb 16, 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350 · LZO
Biomet, Inc.
Orthopedic · 87d
Cleared Feb 16, 1996
IMMULITE HGH
K955376 · CFL
Diagnostic Products Corp.
Chemistry · 84d