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
124633–124656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1990
SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST
K902817 · EMA
Confi-Dental Products Co.
Dental · 62d
Cleared Aug 28, 1990
TOY SUNGLASSES
K903202 · HQY
Creative Design
Ophthalmic · 39d
Cleared Aug 27, 1990
MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT
K896918 · DEH
Dako Corp.
Hematology · 259d
Cleared Aug 27, 1990
LIFECARE MODEL 4 PUMP
K900467 · FRN
Abbott Laboratories
General Hospital · 208d
Cleared Aug 27, 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · FRN
Abbott Laboratories
General Hospital · 208d
Cleared Aug 27, 1990
YSI MODEL 1500 SPORT L-LACTATE ANALYZER
K901131 · KHP
Yellow Springs Instrument Co., Inc.
Chemistry · 168d
Cleared Aug 27, 1990
UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER
K902585 · KOE
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 76d
Cleared Aug 27, 1990
DRAPE, SURGICAL - UTILITY DRAPE - STERILE
K903726 · KKX
Graham Medical Products
General Hospital · 11d
Cleared Aug 24, 1990
LUMISCOPE EMS 8000
K901849 · IPF
Lumiscope Co., Inc.
Physical Medicine · 122d
Cleared Aug 24, 1990
MODIFIED AML + ACETABULAR CUP SYSTEM
K902395 · JDI
Depuy, Inc.
Orthopedic · 86d
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