FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132841–132864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1989
BITE BLOCK #59430
K890567 · JXL
Medi-Source, Inc.
Neurology · 11d
Cleared Feb 17, 1989
BION DIRECT IDENTIFICATION CONTROL SLIDE
K890616 · LJG
Bion Ent., Ltd.
Microbiology · 10d
Cleared Feb 17, 1989
JAMES REAGENT
K890625 · JTO
Dms Products, Inc.
Microbiology · 10d
Cleared Feb 16, 1989
PRO DISCS
K882630 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 234d
Cleared Feb 16, 1989
ALN DISCS
K882636 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 234d
Cleared Feb 16, 1989
ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270
K884312 · KPT
Atomic Products Corp.
Radiology · 126d
Cleared Feb 16, 1989
KODAK SURECELL HERPES (HSV) TEST KIT
K884680 · LGC
Eastman Kodak Company
Microbiology · 99d
Cleared Feb 16, 1989
CLINICAL ELECTRONIC THERMOMETERS
K884765 · FLL
Sheridan Catheter Corp.
General Hospital · 94d
Cleared Feb 16, 1989
ANGIOSTAR
K884912 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 80d
Cleared Feb 16, 1989
COULTER 5P CONTROL
K885028 · GKZ
Coulter Electronics, Inc.
Hematology · 73d
Cleared Feb 16, 1989
SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM
K885127 · LMC
Fischer Imaging Corp.
Radiology · 66d
Cleared Feb 16, 1989
EXPANDABLE BILIARY STENT ENDOPROSTHESIS
K885180 · FGE
Schneider Intl., Ltd.
Gastroenterology & Urology · 64d
Cleared Feb 16, 1989
MURINE MONOCLONAL ANTI-ADENOVIRUS IGG
K885310 · GNY
Whittaker Bioproducts, Inc.
Microbiology · 49d
Cleared Feb 16, 1989
KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000
K890097 · LMC
Eastman Kodak Company
Radiology · 37d
Cleared Feb 16, 1989
WELLCOLEX COLOUR SALMONELLA TEST ZL 50
K890146 · GRM
Wellcome Diagnostics
Microbiology · 34d
Cleared Feb 16, 1989
MICROSURGICAL KERATOME
K890216 · GZX
Kinetic Medical Products
Neurology · 29d
Cleared Feb 16, 1989
HYSTERECTOMY FORCEPS
K890383 · HCZ
Kinetic Medical Products
Obstetrics & Gynecology · 24d
Cleared Feb 16, 1989
KODAK PORTABLE IDENTIFICATION CAMERA
K890467 · JAC
Eastman Kodak Company
Radiology · 16d
Cleared Feb 15, 1989
CTS-3060 AUTOMATED SEMEN ANALYZER
K881765 · POV
Motion Analysis Corp.
Hematology · 296d
Cleared Feb 15, 1989
XOMED IONESTHETIZER(TM)
K884834 · EGJ
Xomed, Inc.
Physical Medicine · 89d
Cleared Feb 15, 1989
ENDOSTROBOSCOPE IV
K884933 · EQL
Jedmed Instrument Co.
Ear, Nose, Throat · 79d
Cleared Feb 15, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGA
K890560 · CZP
Atlantic Antibodies
Immunology · 22d
Cleared Feb 14, 1989
HOMER MAMMALOK LOCALIZATION SHIELD
K885090 · LRO
North American Instrument Corp.
General & Plastic Surgery · 64d
Cleared Feb 14, 1989
AIR DISPLACEMENT PIPETTE
K885340 · JQW
Ulster Scientific, Inc.
Chemistry · 48d