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
125233–125256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1990
MODIFIED DEPUY ACETABULAR CUP SYSTEM
K902396 · JDI
Depuy, Inc.
Orthopedic · 86d
Cleared Aug 24, 1990
WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET
K902477 · DYB
Medical Engineering and Development...
Cardiovascular · 81d
Cleared Aug 24, 1990
NM INJECTION NEEDLES
K902736 · FBK
Olympus Corp.
Gastroenterology & Urology · 64d
Cleared Aug 24, 1990
BC BRUSHES
K902737 · FDX
Olympus Corp.
Gastroenterology & Urology · 64d
Cleared Aug 24, 1990
SCAN COM AND SCAN COM P (TENTATIVE)
K903652 · ILQ
Med Labs, Inc.
Physical Medicine · 11d
Cleared Aug 23, 1990
ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST
K896494 · LQF
Gen-Probe, Inc.
Microbiology · 283d
Cleared Aug 23, 1990
ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE
K897077 · LQF
Gen-Probe, Inc.
Microbiology · 244d
Cleared Aug 23, 1990
MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)
K900515 · DYB
Medtronic Vascular
Cardiovascular · 202d
Cleared Aug 23, 1990
INTRODUCER, PERCUTANEOUS
K900658 · DYB
Novoste Puerto Rico, Inc.
Cardiovascular · 195d
Cleared Aug 23, 1990
ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K900805 · IYO
Ge Medical Systems Information...
Radiology · 183d
Cleared Aug 23, 1990
MANAN ARTERIAL CATHETER NEEDLE
K900978 · DQY
Manan Medical Products, Inc.
Cardiovascular · 174d
Cleared Aug 23, 1990
CENTRALSCOPE 12
K901072 · DXJ
Marquette Electronics, Inc.
Cardiovascular · 169d
Cleared Aug 23, 1990
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · KZD
Abbott Laboratories
General Hospital · 162d
Cleared Aug 23, 1990
BP50 BLOOD PRESSURE AND PULSE MONITOR
K901392 · DXN
Pulse Time Products, Ltd.
Cardiovascular · 150d
Cleared Aug 23, 1990
MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.
K901504 · DQA
Ivy Biomedical Systems, Inc.
Anesthesiology · 147d
Cleared Aug 23, 1990
FUKUDA DENSHI MODEL FX-3101
K901817 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 122d
Cleared Aug 23, 1990
MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM
K902044 · LNH
Instrumentarium Imaging, Inc.
Radiology · 108d
Cleared Aug 23, 1990
MODEL MSC SA02-5000 PULSE OXIMETER
K902192 · DQA
Medical Systems Corp.
Anesthesiology · 99d
Cleared Aug 23, 1990
THERAVIEW DIGITAL PORTAL IMAGING COMPUTER
K902339 · IYE
S & S Inficon, Inc.
Radiology · 91d
Cleared Aug 23, 1990
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR
K902355 · DTP
Medtronic Vascular
Cardiovascular · 86d
Cleared Aug 23, 1990
DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS)
K902441 · KDD
Currie Medical Specialties, Inc.
General & Plastic Surgery · 83d
Cleared Aug 23, 1990
OSCILLOMETRIC PULSE DETECTION DEVICE
K902453 · DRS
Thomas J. Fogarty, M.D.
Cardiovascular · 83d
Cleared Aug 23, 1990
BYRD DILATOR SHEATH SET - TEFLON
K902469 · DRE
Medical Engineering and Development...
Cardiovascular · 80d
Cleared Aug 23, 1990
MORSE DT MANIFOLD
K902472 · DRS
North American Instrument Corp.
Cardiovascular · 80d