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
163417–163440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1981
CONTACT LENS CLEANER
K812172 · HPX
Alcon Laboratories
Ophthalmic · 32d
Cleared Aug 31, 1981
SMITH'S SYSTEMIC FUNGAL MEDIUM
K812187 · JSI
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI
K812188 · GMD
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
COCCIDIOIDES IMMUNODIFFUSION SYSTEM
K812190 · GMI
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
VASPAR SEALENT
K812191 · KEO
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
LACTO-PHENOL ANILINE BLUE MOUNTING FLUID
K812192 · LED
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
KOH MOUNTING FLUID
K812193 · LEB
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
IMMUNODIFFUSION BAND INTENSIFYING FLUID
K812194 · JZS
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
DACRON PLEDGET SUTURE BUTTRESS
K812254 · DXZ
Ethicon, Inc.
Cardiovascular · 19d
Cleared Aug 31, 1981
ACR ENZYMATIC GLUCOSE OXIDASE
K812258 · CGA
Harleco
Chemistry · 19d
Cleared Aug 31, 1981
ACCURATE I
K812261 · JHJ
Organon, Inc.
Chemistry · 19d
Cleared Aug 31, 1981
CENTRAL STATION MONITOR
K812271 · DRT
Datascope Corp.
Cardiovascular · 18d
Cleared Aug 31, 1981
MONOJECT STERILE CORVAC BLOOD TUBE
K812285 · JKA
Sherwood Medical Co.
Chemistry · 18d
Cleared Aug 31, 1981
HUMAN C-PEPTIDE REAGENTS
K812288 · JKD
Immunex Radiochemical Diagnostics
Chemistry · 18d
Cleared Aug 31, 1981
FUN-UV SYSTEM PACK TEST
K812290 · CDQ
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Aug 31, 1981
CENTRICHEM CHOLESTEROL REAGENT & CALIBRA
K812293 · CHH
Baker Diagnostics
Chemistry · 18d
Cleared Aug 31, 1981
CONVEEN URISHEATH & CONVEEN URILINER
K812294 · KNX
Telcam Medical Devices, Inc.
Gastroenterology & Urology · 17d
Cleared Aug 31, 1981
GAMMA GLUTAMY TRANSPEPTIDASE
K812296 · JQB
Pointe Scientific, Inc.,
Chemistry · 17d
Cleared Aug 31, 1981
LANCER BUN RATE REAGENT KIT
K812308 · CDS
Sherwood Medical Co.
Chemistry · 14d
Cleared Aug 31, 1981
THERAPY BENCH
K812319 · IOD
Kaye Products, Inc.
Physical Medicine · 14d
Cleared Aug 31, 1981
COBE PPD 1.9
K812336 · FJG
Cobe Laboratories, Inc.
Gastroenterology & Urology · 13d
Cleared Aug 25, 1981
GLYCERINE DEHYDRATION UNIT
K810400
Xytex Corp.
Ophthalmic · 188d
Cleared Aug 25, 1981
INCONTINENT PAD
K811482 · KNO
Fred Sammons, Inc.
Physical Medicine · 91d
Cleared Aug 25, 1981
PHOSPHATE BUFFERED SALINE (1X)
K811791 · JCC
Dutchland Laboratories, Inc.
Chemistry · 62d