FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84169–84192 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1999
DRUG STOP
K991465 · MVO
Texas Immunology, Inc.
Toxicology · 227d
Cleared Dec 10, 1999
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
K991714 · DQD
Doctor'S Research Group, Inc.
Cardiovascular · 204d
Cleared Dec 10, 1999
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
K991756 · DQD
Bio-Research Associates, Inc.
Cardiovascular · 200d
Cleared Dec 10, 1999
LUMA-CATH STEERABLE EP CATHETERS
K991878 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 191d
Cleared Dec 10, 1999
CUSTODIOL
K992209 · KDN
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 163d
Cleared Dec 10, 1999
VIT ENHANCER
K992943 · HQE
Medical Instrument Development...
Ophthalmic · 101d
Cleared Dec 10, 1999
CHEST DRAINAGE TUBING
K993062 · DWE
Olson Medical Sales, Inc.
Cardiovascular · 88d
Cleared Dec 10, 1999
SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
K993072 · MKJ
Survivalink Corp.
Cardiovascular · 87d
Cleared Dec 10, 1999
SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525
K993074 · MAI
Bionx Implants, Ltd.
Orthopedic · 87d
Cleared Dec 10, 1999
ENDOSCOPES,10MM DIAMETER 0 DEGREES
K993103 · GCM
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 85d
Cleared Dec 10, 1999
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
K993226 · EZD
Memcath Technologies, LLC
Gastroenterology & Urology · 74d
Cleared Dec 10, 1999
ENDOPEARL WITH THREADER
K993339 · MAI
Linvatec Corp.
Orthopedic · 66d
Cleared Dec 10, 1999
BARDEX I.C. PEDIATRIC FOLEY CATHETER
K993464 · MJC
C.R. Bard, Inc.
Gastroenterology & Urology · 58d
Cleared Dec 10, 1999
CG-7000DX ECG RECORDER/TRANSMITTER
K993799 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 31d
Cleared Dec 10, 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K993822 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Dec 10, 1999
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
K993833 · BZE
Allegiance Healthcare Corp.
Anesthesiology · 28d
Cleared Dec 10, 1999
PREMIER TOXINS A&B, MODEL 616096
K993914 · LLH
Meridian Diagnostics, Inc.
Microbiology · 23d
Cleared Dec 09, 1999
MICROSTREP PLUS PANEL
K983746 · JWY
Dade Microscan, Inc.
Microbiology · 412d
Cleared Dec 09, 1999
RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
K983907 · GZJ
Woodside Biomedical, Inc.
Neurology · 401d
Cleared Dec 09, 1999
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
K990503 · DSY
Sulzermedica
Cardiovascular · 295d
Cleared Dec 09, 1999
IRIDERM, MODEL APEX 800
K992298 · GEX
Iridex Corp
General & Plastic Surgery · 154d
Cleared Dec 09, 1999
LEMAITRE EMBOLECTOMY CATHETER
K992368 · DXE
Vascutech, Inc.
Cardiovascular · 147d
Cleared Dec 09, 1999
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS,...
K992581 · GEI
Arthrocare Corp.
General & Plastic Surgery · 129d
Cleared Dec 09, 1999
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3
K992939 · JJY
Seracare Technology
Immunology · 100d