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
162577–162600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 25, 1981
BIOPSY TRANSDUCER
K811843 · ITX
Siemens Gammasonics, Inc.
Radiology · 55d
Cleared Aug 25, 1981
30-30-2 700 SYRINGE EXTENSION SET
K811885 · FPA
Y
General Hospital · 55d
Cleared Aug 25, 1981
CENTURY BIRTHING CHAIR
K811902 · KNC
Century Manufacturing Co.
Obstetrics & Gynecology · 55d
Cleared Aug 25, 1981
VISITEC NEEDLE RANGE (GASTERUROLOGY)
K811965 · FHR
Visitec Co.
General & Plastic Surgery · 46d
Cleared Aug 25, 1981
VIVONEX TUNGSTEN TIP
K811968 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 46d
Cleared Aug 25, 1981
KING DIAGNOSTICS HEMOGLOBIN TEST
K812127 · GKR
King Diagnostics, Inc.
Hematology · 29d