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
93937–93960 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 1997
KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)
K962753 · DZE
Biomedical Implant Technology, Inc.
Dental · 308d
Cleared May 19, 1997
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
K963202 · HCC
Mega Electronics , Ltd.
Neurology · 277d
Cleared May 19, 1997
FREEDOM TRAVELLER
K964825 · MLW
Impact Case Technologies, Inc.
Gastroenterology & Urology · 168d
Cleared May 19, 1997
VIEWPOINT - 3.0 SOFTWARE
K970604 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 90d
Cleared May 19, 1997
BC THROMBIN REAGENT
K970645 · GJA
Behring Diagnostics, Inc.
Hematology · 88d
Cleared May 19, 1997
LUMBAR DRAINAGE ACCESSORY KIT
K970658 · JXG
Integra Neurocare, LLC
Neurology · 87d
Cleared May 19, 1997
GALILEO HALLEY
K970703 · GWQ
Biosound Esaote, Inc.
Neurology · 82d
Cleared May 19, 1997
GRASS BRAINWAVE SOFTWARE
K970951 · OLV
Astro-Med, Inc.
Neurology · 66d
Cleared May 19, 1997
WHITE RIVER MINI MANUAL BREAST PUMP
K971231 · HGY
White River Concepts
Obstetrics & Gynecology · 46d
Cleared May 16, 1997
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
K953647 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 651d
Cleared May 16, 1997
MANAN V.S. ACCESS NEEDLE/SET
K963767 · FGE
Manan Medical Products, Inc.
Gastroenterology & Urology · 239d
Cleared May 16, 1997
BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)
K964605 · FLL
Thermoscan, Inc.
General Hospital · 179d
Cleared May 16, 1997
FLEXICAIR EXLIPSE PLUS
K970295 · IOQ
Hill-Rom, Inc.
Physical Medicine · 109d
Cleared May 16, 1997
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
K970362 · FNM
Apex Metal, Inc.
General Hospital · 105d
Cleared May 16, 1997
DHD EMERALD PRODUCT
K970596 · BWF
Dhd Diemolding Healthcare Div.
Anesthesiology · 87d
Cleared May 16, 1997
HERO 642
K970649 · EKS
Micro-Mega
Dental · 85d
Cleared May 16, 1997
DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
K970659 · GYE
Telediagnostic Systems, Inc.
Neurology · 84d
Cleared May 16, 1997
OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
K970716 · EZL
Opticon Medical, Inc.
Gastroenterology & Urology · 78d
Cleared May 16, 1997
DSL ESTRONE-SULFATE RIA
K970915 · CGF
Diagnostic Systems Laboratories, Inc.
Chemistry · 65d
Cleared May 16, 1997
TM MICRO-CATHETERS
K971124 · ETD
Xomed, Inc.
Ear, Nose, Throat · 50d
Cleared May 16, 1997
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
K971177 · CDD
Diagnostic Products Corp.
Chemistry · 46d
Cleared May 16, 1997
SYNCHRON SYSTEMS THYROXINE REAGENT
K971203 · KLI
Beckman Instruments, Inc.
Chemistry · 45d
Cleared May 16, 1997
ALP REAGENT SET
K971463 · CJE
Carolina Liquid Chemistries Corp.
Chemistry · 25d
Cleared May 16, 1997
TOTAL PROTEIN OR TP
K971524 · CEK
Carolina Liquid Chemistries Corp.
Chemistry · 18d