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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83665–83688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 09, 1999
AROMATIC AND FLAVORED TONGUE DEPRESSOR
K992995 · FMA
Aga Plastic Ind. Com. Ltda.
General Hospital · 93d
Cleared Dec 09, 1999
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1,...
K993054 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Dec 09, 1999
RUSCH BRILLANT SILICONE FOLEY
K993063 · EZL
Rusch Intl.
Gastroenterology & Urology · 87d
Cleared Dec 09, 1999
FRIALIT-2 SELECT COMPONENTS
K993095 · DZE
Friadent GmbH
Dental · 84d
Cleared Dec 09, 1999
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106 · HRS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Dec 09, 1999
XOMED ENT RF SYSTEM
K993112 · GEI
Xomed, Inc.
General & Plastic Surgery · 83d
Cleared Dec 09, 1999
AUROFLUID M, ALLOY NO. 5315
K993475 · EJS
Metalor Dental USA Corp.
Dental · 56d
Cleared Dec 09, 1999
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
K993631 · JJY
Seracare Technology
Immunology · 43d
Cleared Dec 09, 1999
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
K993821 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 27d