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
126241–126264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1990
TYPE 9140/NEO
K896700 · DRT
S & W Medico Teknik
Cardiovascular · 143d
Cleared Apr 20, 1990
INTRAVASCULAR IMAGING SYSTEMS
K900305 · LYK
Intertherapy, Inc.
Cardiovascular · 89d
Cleared Apr 20, 1990
HEMODIALYSIS BLOOD LINES
K900306 · KOC
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 89d
Cleared Apr 20, 1990
ADAIR/VERESS NEEDLE INTRODUCER SET
K900374 · GCB
Medical Dynamics, Inc.
General & Plastic Surgery · 84d
Cleared Apr 20, 1990
APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER
K900486 · GDT
Davis & Geck, Inc.
General & Plastic Surgery · 78d
Cleared Apr 20, 1990
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
K900550 · DTB
Pacesetter Systems
Cardiovascular · 73d
Cleared Apr 20, 1990
MODEL 5866-34 LEAD ADAPTOR KIT
K900627 · DTD
Medtronic Vascular
Cardiovascular · 71d
Cleared Apr 20, 1990
MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
K900640 · DTR
3M Company
Cardiovascular · 70d
Cleared Apr 20, 1990
MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR
K900707 · LFW
Innotron of Oregon, Inc.
Toxicology · 67d
Cleared Apr 20, 1990
EMIT D.A.U. AMPHETAMINE CLASS ASSAY
K900995 · DKZ
Syva Co.
Toxicology · 50d
Cleared Apr 20, 1990
PRO TREATMENT TABLE
K901526 · JFB
R&R Ent., Inc.
Physical Medicine · 18d
Cleared Apr 20, 1990
HPI POWDER FREE NON-STERILE EXAMINATION GLOVES
K901608 · LYY
Hpi, Inc.
General Hospital · 14d
Cleared Apr 20, 1990
FORTRESS COMMUTER RT (RIGID TRANSPORT)
K901708 · ITI
Fortress, Inc.
Physical Medicine · 7d
Cleared Apr 19, 1990
MENSOR MAGNASKIRT
K885159 · DZE
Merrill C. Mensor, Jr., D.D.S.
Dental · 492d
Cleared Apr 19, 1990
OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM
K893780 · BSZ
Ohmeda Medical
Anesthesiology · 332d
Cleared Apr 19, 1990
BALLOON THERMODILUTION CATHETERS
K894401 · DQO
Worldwide Medical
Cardiovascular · 304d
Cleared Apr 19, 1990
MYOSYSTEM 1000 ELECTROMYOGRAPH
K895635 · HCC
Noraxon USA, Inc.
Neurology · 212d
Cleared Apr 19, 1990
ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE
K896540 · IZD
Nuclear Data Systems
Radiology · 155d
Cleared Apr 19, 1990
LATEX EXAMINATION GLOVES
K896752 · LYY
Aquatic Import & Export Corp.
General Hospital · 140d
Cleared Apr 19, 1990
ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/
K896785 · ELW
Craft Dental Laboratory, Inc.
Dental · 136d
Cleared Apr 19, 1990
ZONAREX FINAL IMPRESSION COMPOUND
K896786 · ELW
Craft Dental Laboratory, Inc.
Dental · 136d
Cleared Apr 19, 1990
MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK
K900271 · HEM
Digisonics, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 19, 1990
OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET
K900275 · DZE
Collagen Corp.
Dental · 90d
Cleared Apr 19, 1990
SERIES 3001 IABP
K900281 · DSP
Boston Scientific Corp
Cardiovascular · 87d