Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
167401–167424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1980
CYBREX GENTAMICIN
K801084 · LCQ
Abbott Laboratories
Toxicology · 16d
Cleared May 23, 1980
NEONATAL BREATHING CIRCUIT SYSTEM
K801087 · BZO
Isothermal Systems, Inc.
Anesthesiology · 16d
Cleared May 23, 1980
ROOMMATE-OXYGEN CONCENTRATOR
K801104 · CAW
Cryogenic Assoc.
Anesthesiology · 14d
Cleared May 23, 1980
PEDIATRIC ANESTHESIA CIRCUIT
K801111 · CAI
Vital Signs, Inc.
Anesthesiology · 11d
Cleared May 23, 1980
IL88640 & 88641 CASSETTE-TAPE PROGRAM
K801131 · JQP
Instrumentation Laboratory CO
Toxicology · 11d
Cleared May 23, 1980
USCI INTRALUMINAL GRAFT W/DACRON TIE
K801156 · DSY
C.R. Bard, Inc.
Cardiovascular · 9d
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