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
148321–148344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1985
GENERAL HOSPITAL INSTRUMENTS
K851852
Biological & Environmental Control...
General & Plastic Surgery · 25d
Cleared May 21, 1985
BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA
K851880 · GFA
J-Pac, LLC
General & Plastic Surgery · 22d
Cleared May 21, 1985
DOUBLE ACTION PIN CUTTER
K851896
Med-Tool, Inc.
General & Plastic Surgery · 21d
Cleared May 21, 1985
SURGICAL EYE PACK
K851906 · HMP
Xanmed Corp.
General & Plastic Surgery · 20d
Cleared May 20, 1985
ELVI 655 FLAME PHOTOMETER
K843375 · JJO
Logos Scientific, Inc.
Chemistry · 265d
Cleared May 20, 1985
ABBOTT HSV EIA
K843622 · LGC
Abbott Laboratories
Immunology · 248d
Cleared May 20, 1985
VIROGEN RUBELLA SLIDE TEST
K844435 · LQN
Armkel, LLC
Microbiology · 185d
Cleared May 20, 1985
NEUROLAB II
K844481 · GWS
Teca, Inc.
Neurology · 182d
Cleared May 20, 1985
MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA
K845021 · HIF
Medline Industries, Inc.
Obstetrics & Gynecology · 144d
Cleared May 20, 1985
ORTHOPEDIC IMPLANT SCREWS
K850024 · HWC
Kirkstil Corp., Inc.
Orthopedic · 137d
Cleared May 20, 1985
ORTHOPEDIC IMPLANT PLATES
K850025 · HRS
Kirkstil Corp., Inc.
Orthopedic · 137d
Cleared May 20, 1985
ORTHOPEDIC IMPLANT NAILS & PINS
K850026 · HTY
Kirkstil Corp., Inc.
Orthopedic · 137d
Cleared May 20, 1985
SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS
K850354 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 110d
Cleared May 20, 1985
ELECTROSURGICAL UNIT 774
K850668 · GEI
Birtcher Corp.
General & Plastic Surgery · 89d
Cleared May 20, 1985
CONCEPT VIDEO IMAGING SYSTEM
K850749 · KQM
Concept, Inc.
General & Plastic Surgery · 84d
Cleared May 20, 1985
TOXOSCAN CARD TEST KIT
K850768 · LLA
Bd Becton Dickinson Vacutainer...
Microbiology · 84d
Cleared May 20, 1985
MODEL 775 BIPOLAR COAGULATOR
K850943 · GEI
Birtcher Corp.
General & Plastic Surgery · 74d
Cleared May 20, 1985
FISHER DIAGNOSTICS KDA CALIBRATOR I
K851150 · JIX
Fisher Scientific Co., LLC
Chemistry · 60d
Cleared May 20, 1985
FISHER DIAGNOSTICS KDA CALIBRATOR II
K851151 · JIX
Fisher Scientific Co., LLC
Chemistry · 60d
Cleared May 20, 1985
MICROSTATIC URINE TRANSPORT TUBE FOR C & S
K851387 · LIO
Analytical Luminescence Laboratory, Inc.
Microbiology · 41d
Cleared May 20, 1985
ULTRA-VIOLET BUN REAGENT KIT
K851513 · CDQ
Bio-Analytics Laboratories, Inc.
Chemistry · 35d
Cleared May 20, 1985
ULTRA-VIOLET GLUCOSE REAGENT
K851514 · CFA
Bio-Analytics Laboratories, Inc.
Chemistry · 35d
Cleared May 20, 1985
TRIGLYCERIDE(TRINDER) PROCEDURE
K851538 · CDT
Data Medical Associates, Inc.
Chemistry · 34d
Cleared May 20, 1985
NOVASPEC VISIBLE SPECTROPHOTOMETER
K851572 · JJQ
Lkb Instruments, Inc.
Toxicology · 33d