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
155545–155568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1983
TOXO IPA KIT IAN INDIRECT FLUORESCENT
K832069 · LJK
Bionetic Laboratory Products
Immunology · 91d
Cleared Sep 26, 1983
DIGIDENT ELEKTRONIC APEX LOCATOR
K832118
Ora-Muszeripari Szovetkezet
General & Plastic Surgery · 88d
Cleared Sep 26, 1983
TRAVELER NEBULIZING SYSTEM
K832220 · BTI
Medix of Florida, Inc.
Anesthesiology · 80d
Cleared Sep 26, 1983
DUPONT ISOLATOR 1.5 MICROBIAL TUBE
K832246 · LIO
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 77d
Cleared Sep 26, 1983
CERESTORE CORE MATERIAL
K832286 · EIH
Johnson & Johnson Professionals, Inc.
Dental · 75d
Cleared Sep 26, 1983
ORAL SAFE
K832359 · JER
Great Lakes Orthodontics, Ltd.
Dental · 70d
Cleared Sep 26, 1983
ZOLLER BURNED LIP CONFORMER
K832366 · EIG
Universal Prosthetics, Inc.
Dental · 70d
Cleared Sep 26, 1983
QUANTUM II YEAST IDENT. SYSTEM
K832406 · JXC
Abbott Laboratories
Microbiology · 67d
Cleared Sep 26, 1983
SELECTRO-DISC
K832436 · JTO
Lab Ability, Inc.
Immunology · 63d
Cleared Sep 26, 1983
ARTERIAL BLOOD SAMPLING KIT
K832545 · CBT
Dhd Medical Products Div. Diemolding...
Anesthesiology · 59d
Cleared Sep 26, 1983
CELL-DYN 900 HEMATOLOGY ANALYZER
K832643 · GKL
Abbott Diagnostics
Hematology · 53d
Cleared Sep 26, 1983
HEATED GUTTA PERCHA DELIVERY SYSTEM
K832654 · EKM
Unitek Corp.
Dental · 49d
Cleared Sep 26, 1983
ECOLYZER #200/COHB ANALYZER SYS
K832655 · CCJ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 49d
Cleared Sep 26, 1983
OXYGEN CONNECTING TUBESET-RESPIRATORY
K832660 · BYX
San Diego Plastics, Inc.
Anesthesiology · 49d
Cleared Sep 26, 1983
UNIVERSAL VOL. VENTILATOR 72 #1626
K832681 · BZO
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 48d
Cleared Sep 26, 1983
SKIN STAPLING DEVICE SC2000
K832709 · GDT
Prosper, Inc.
General & Plastic Surgery · 45d
Cleared Sep 26, 1983
EASYTOUCH HEMOGLOBIN REAGENT
K832750 · KHG
Worthington Diagnostic Systems
Chemistry · 42d
Cleared Sep 26, 1983
LANE ONE
K832770 · IKK
Loredan Biomedical, Inc.
Physical Medicine · 41d
Cleared Sep 26, 1983
EPIDURAL SYRINGE
K832778 · CAZ
Concord Laboratories, Inc.
Anesthesiology · 41d
Cleared Sep 26, 1983
NEOCATH 1000 W/HEPCOTE
K832793 · CCE
Orange Medical Instruments, Inc.
Anesthesiology · 38d
Cleared Sep 26, 1983
MUL-T-PAD
K832819 · ILO
Gaymar Industries, Inc.
Physical Medicine · 38d
Cleared Sep 26, 1983
MUL-T-BLANKET
K832820 · ILO
Gaymar Industries, Inc.
Physical Medicine · 38d
Cleared Sep 26, 1983
NUTRIENT MIXTURE F-10 #N6635 W/L-GLUTA
K832837 · KIT
Sigma Chemical Co.
Chemistry · 38d
Cleared Sep 26, 1983
EARLES BALANCED SALT MIXTURE #E6132
K832838 · KIT
Sigma Chemical Co.
Chemistry · 38d