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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
93433–93456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 15, 1997
P.H.D. - PERSONAL HEART DEVICE MODEL 5258
K963904 · DXH
Heart Alert, Inc.
Cardiovascular · 227d
Cleared May 15, 1997
AMBU SPUR NEONATE
K964584 · BTM
Ambu, Inc.
Anesthesiology · 181d
Cleared May 15, 1997
HEWLETT-PACKARD CENTRALVUE SOFTWARE
K964832 · DSI
Hewlett-Packard Co.
Cardiovascular · 164d
Cleared May 15, 1997
NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S,...
K970639 · GXY
Medicotest, Inc.
Neurology · 84d
Cleared May 15, 1997
700-SP SERIES DISPOSABLE STIMULATION ELECTRODES
K971148 · MKJ
Cardiotronics Systems, Inc.
Cardiovascular · 48d
Cleared May 15, 1997
QUANTUM 3080SP SURGICAL TABLE
K971390 · GDC
STERIS Corporation
General & Plastic Surgery · 31d
Cleared May 14, 1997
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
K964518 · DYB
Daig Corp.
Cardiovascular · 201d
Cleared May 14, 1997
ODYSSEY I DENTAL WATER UNIT
K964796 · EIA
Germiphene Corp.
Dental · 166d
Cleared May 14, 1997
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K964869 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 161d