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
166561–166584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1980
NDM DIATEMP ELECTROSURGICAL DIS. PAD
K801158 · GEI
Ndm Corp.
General & Plastic Surgery · 9d
Cleared May 23, 1980
BARRIER PLUS SURGEON GOWNS
K801162 · FYC
American Hospital Supply Corp.
General Hospital · 8d
Cleared May 23, 1980
HYPERSTETHOSCOPE, MODEL Z 00
K801165 · DQD
Demonbinder Electronics
Cardiovascular · 8d
Cleared May 23, 1980
OXYGEN TUBING (CRUSH RESISTANT)/VINYL TP
K801190 · BYX
Airlife, Inc.
Anesthesiology · 4d
Cleared May 20, 1980
MODEL 5985 PACEMAKER PULSE GENERATOR
K800285 · DXY
Medtronic Vascular
Cardiovascular · 102d
Cleared May 20, 1980
VACUDENT LUMIX 65
K800574 · EHP
Vacudent Sales Corp.
Dental · 67d
Cleared May 20, 1980
VACUDENT LUMIX 70
K800575 · EHP
Vacudent Sales Corp.
Dental · 67d
Cleared May 20, 1980
MOD. DM-356 IPS INTERFACE MODULE
K800771 · FKQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 43d
Cleared May 20, 1980
FLARE DIS. CONDUCTIVE&NON. SHOE COVERS
K800809 · FXP
Flare Products, Inc.
General Hospital · 40d
Cleared May 20, 1980
FLARE DIS. NONWOVEN HEAD COVERS
K800810 · FYF
Flare Products, Inc.
General & Plastic Surgery · 40d
Cleared May 20, 1980
VIRAL CULTURETTE HANK'S BAL. SALT SOL.
K800832 · JSM
Marion Health & Safety, Inc.
Microbiology · 36d
Cleared May 20, 1980
KODAK EKTASPEED DENTAL X-RAY FILM
K800901 · IWZ
Eastman Kodak Company
Radiology · 32d
Cleared May 20, 1980
TOMAC WET DRESSING WARMER
K800907 · KGX
W.G. Whitney Corp.
General & Plastic Surgery · 29d
Cleared May 20, 1980
WHITE KNIGHT DISP. STERILE BACK GOWN
K800927 · FYA
G.D. Searle and Co.
General Hospital · 29d
Cleared May 20, 1980
WHITE KNIGHT SUPPLEMENTAL DRAPE
K800928 · KKX
G.D. Searle and Co.
General Hospital · 29d
Cleared May 20, 1980
WHITE KNIGHT SURGICAL PACK
K800929 · FYA
G.D. Searle and Co.
General Hospital · 29d
Cleared May 20, 1980
R2 ELECTROSURG. RETURN ELECT. #225ETC.
K800933 · JOT
R2 Corp.
General & Plastic Surgery · 29d
Cleared May 20, 1980
R2 ESU CABLE-ADAPTER MODELS 160,161
K800934 · IKD
R2 Corp.
Physical Medicine · 29d
Cleared May 20, 1980
FIXOMULL STERILE
K800953 · NAD
Beiersdorf, Inc.
General & Plastic Surgery · 27d
Cleared May 20, 1980
CHARNLEY DESIGN HIP PROSTHESIS
K801006 · JDG
Colmed, Ltd.
Orthopedic · 22d
Cleared May 20, 1980
KIRSCHNER WIRE
K801010 · HSB
American Safety Equipment Corp.
Orthopedic · 22d
Cleared May 20, 1980
125I-IGE RADIOIMMUNOASSAY KIT
K801019 · DGC
Bio-Ria
Immunology · 20d
Cleared May 20, 1980
RICA OR SMIC SURGICAL INSTRUMENTS
K801028 · HXD
Robert I. Chien & Assoc., Inc.
General & Plastic Surgery · 19d
Cleared May 20, 1980
STERILE DRAPE 17X18 CODE D-6A
K801032 · KKX
Veratex Corp.
General Hospital · 19d