FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129601–129624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1989
MAESTRO PACEMAKER TEST MAGNET
K895110 · DTG
Cardiac Control Systems, Inc.
Cardiovascular · 42d
Cleared Sep 26, 1989
MINIMON 7137B PATIENT MONITOR
K895425 · DQA
Kontron Instruments, Inc.
Anesthesiology · 19d
Cleared Sep 26, 1989
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
K895495 · DXY
Medtronic Vascular
Cardiovascular · 29d
Cleared Sep 26, 1989
LATEX PATIENT EXAMINATION GLOVES
K895536 · LYY
Perfect Latex Pvt. , Ltd.
General Hospital · 13d
Cleared Sep 26, 1989
ORIENT, LATEX EXAMINATION GLOVES
K895558 · LYY
Rosa Intl.
General Hospital · 20d
Cleared Sep 25, 1989
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K885220 · KNT
Ethox Corp.
Gastroenterology & Urology · 279d
Cleared Sep 25, 1989
SERIES 3 GENERAL SUCTION SYSTEM
K891129 · BTA
Ultravac, Inc.
General & Plastic Surgery · 206d
Cleared Sep 25, 1989
MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM
K892895 · KNS
Everest Medical Corp.
Gastroenterology & Urology · 153d
Cleared Sep 25, 1989
QUICK CHANGE MONTGOMERY STRAP
K893569 · KGX
Med-Dex Intl.
General & Plastic Surgery · 139d
Cleared Sep 25, 1989
NTI-1000
K894097 · QJQ
Neurotek, Inc.
Neurology · 108d
Cleared Sep 25, 1989
FREE T3 RADIOIMMUNOASSAY KIT
K894200 · CDP
Advanced Magnetics, Inc.
Chemistry · 101d
Cleared Sep 25, 1989
ABBOTT SPECTRUM(R) CALCIUM REAGENT
K894407 · CIC
Abbott Laboratories
Chemistry · 70d
Cleared Sep 25, 1989
FPR DIGOXIN KIT
K894521 · KXT
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
FPR DIGOXIN CALIBRATOR KIT
K894522 · DLJ
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
FPR PHENYTOIN KIT
K894527 · DLP
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
FPR PHENYTOIN CALIBRATOR KIT
K894528 · DLG
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS
K895143 · GEX
Lumenis, Inc.
General & Plastic Surgery · 38d
Cleared Sep 25, 1989
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
K895210 · DKZ
Abbott Laboratories
Toxicology · 38d
Cleared Sep 25, 1989
ACTIDERM (TM) DERMATOLOGICAL PATCH
K895376 · KGX
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 26d
Cleared Sep 22, 1989
COIL AND COIL DELIVERY SYSTEM
K891688 · HCG
Target Therapeutics
Neurology · 184d
Cleared Sep 22, 1989
HOLTAIN BODY COMPOSITION ANALYSER
K891928 · DSB
Seritex, Inc.
Cardiovascular · 178d
Cleared Sep 22, 1989
PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE)
K892670 · BZC
Physio-Dyne Instrument Corp.
Anesthesiology · 162d
Cleared Sep 22, 1989
THE INDEPENDENT CARE UNIT
K893745 · FNL
The Water Carriage Co., Inc.
General Hospital · 127d
Cleared Sep 22, 1989
SERVO ANESTHESIA CIRCLE 985
K893786 · CBK
Siemens Life Support Systems
Anesthesiology · 123d