FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87097–87120 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1999
D-SIGN III (R&D PROJECT DW264#7)
K990077 · EJS
Ivoclar North America, Inc.
Dental · 32d
Cleared Feb 12, 1999
D-SIGN IV (R&D PROJECT DW265#37)
K990078 · EJS
Ivoclar North America, Inc.
Dental · 32d
Cleared Feb 12, 1999
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED...
K990083 · FPA
Sims Deltec, Inc.
General Hospital · 32d
Cleared Feb 12, 1999
WILSON-COOK PANCREATIC WEDGE STENT
K990130 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 12, 1999
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
K990259 · FRN
Disetronic Medical Systems
General Hospital · 16d
Cleared Feb 11, 1999
DS30 HCY HOMOCYSTEINE ASSAY KIT
K982003 · LPS
Drew Scientific , Ltd.
Hematology · 248d
Cleared Feb 11, 1999
UNI-GOLD STREP A TEST KIT
K982373 · GTY
Trinity Biotech, Plc
Microbiology · 219d
Cleared Feb 11, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
K983702 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 113d
Cleared Feb 11, 1999
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K983836 · MRC
Polymer Technology Div. Wilmington...
Ophthalmic · 104d
Cleared Feb 11, 1999
ACIST INJECTOR SYSTEM, MODEL CL100 H
K984058 · IZQ
Acist Medical Systems
Cardiovascular · 90d
Cleared Feb 11, 1999
APF POROUS COATED LINE EXTENSION
K984154 · JDI
Biomet, Inc.
Orthopedic · 84d
Cleared Feb 11, 1999
WELCH ALLYN FRONT-LINE DOC
K984215 · LLZ
Welch Allyn, Inc.
Radiology · 79d
Cleared Feb 11, 1999
NEUROVASX SUB-MICROINFUSION CATHETER
K984258 · DQO
Neuro Vasx, Inc.
Cardiovascular · 73d
Cleared Feb 11, 1999
INFINITY GLUCOSE REAGENT
K984574 · CFR
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Feb 11, 1999
SMOOTHLASE ALEXANDRITE LASER SYSTEM
K990043 · GEX
Leisegang Medical, Inc.
General & Plastic Surgery · 36d
Cleared Feb 11, 1999
LOBOB UNIVERSAL CONTACT LENS CLEANER
K990044 · LPN
Lobob Laboratories, Inc.
Ophthalmic · 36d
Cleared Feb 11, 1999
VENTLAB VERIFY II
K990098 · BTR
Ventlab Corp.
Anesthesiology · 30d
Cleared Feb 10, 1999
POTENCY TEST STRIPS, INDICATOR TEST STRIPS
K974426 · LIF
Reprocessing Products Corp
Gastroenterology & Urology · 471d
Cleared Feb 10, 1999
MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER
K983054 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 162d
Cleared Feb 10, 1999
AUTO SUTURE SITE MARKER CLIP
K983400 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 135d
Cleared Feb 10, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
K983704 · JCM
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Feb 10, 1999
CARE TENS
K984025 · GZJ
Care Rehab, Inc.
Neurology · 90d
Cleared Feb 10, 1999
VIPERSOFT
K984030 · EHD
Integra Medical
Radiology · 90d
Cleared Feb 10, 1999
INNOVA TELESCOPIC DISTRACTOR
K984117 · MQN
Innova Corp.
Dental · 85d