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
162121–162144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1981
HIP STEM SYSTEM TITANIUM ALLOY
K812801 · JDI
Osteonics Corp.
Orthopedic · 14d
Cleared Oct 19, 1981
PHOTOGRAPHIC EQUIPMENT
K812201 · FEM
Reznik Instruments
Radiology · 76d
Cleared Oct 19, 1981
PLASTILIX MINIRAD D CASSETTE
K812535 · IXA
Eastman Kodak Company
Radiology · 46d
Cleared Oct 19, 1981
POLAROID INSTANT ENDOCAMERA
K812542 · FEM
Polaroid Corp.
Radiology · 45d
Cleared Oct 19, 1981
MODEL H12-10
K812575 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 40d
Cleared Oct 19, 1981
UNSCENTED MENSTRUAL PADS
K812577 · HHD
Weyerhaeuser Co.
Obstetrics & Gynecology · 40d
Cleared Oct 19, 1981
SCANNER 700
K812588 · IYO
National Ultrasound Corp.
Radiology · 38d
Cleared Oct 19, 1981
FERRITIN KIT
K812597 · DBF
Hybritech, Inc.
Immunology · 35d
Cleared Oct 19, 1981
ADJUSTABLE MICROSURGICAL KNIFE
K812620 · HNN
Vxtra Corp.
Ophthalmic · 34d
Cleared Oct 19, 1981
BECKMAN ICS CALIBRATOR
K812649 · JIX
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Oct 19, 1981
BECKMAN ICS NORMAL CONTROL SERA
K812650 · JJY
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Oct 19, 1981
NEUROMED SELECTRA #7720
K812704 · GZJ
Medtronic Vascular
Neurology · 26d
Cleared Oct 19, 1981
NON-STERILE SHADOW-STRIPE CATHETER
K812717 · FKO
Quinton, Inc.
Gastroenterology & Urology · 24d
Cleared Oct 19, 1981
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
K812718 · FJS
Quinton, Inc.
Gastroenterology & Urology · 24d
Cleared Oct 19, 1981
SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE
K812729 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 19, 1981
SEPTI-CHECK BLOOD CULTURE SLIDE
K812731 · JSI
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 19, 1981
SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE
K812732 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 19, 1981
MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P
K812734 · EQN
Machida America, Inc.
Ear, Nose, Throat · 20d
Cleared Oct 19, 1981
ULTRA-DIG
K812749 · LCS
Antibodies, Inc.
Toxicology · 20d
Cleared Oct 19, 1981
AMES TDA QUINIDINE TEST
K812753 · LBZ
Miles Laboratories, Inc.
Toxicology · 20d
Cleared Oct 19, 1981
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN
K812754 · CIG
Beckman Instruments, Inc.
Chemistry · 19d
Cleared Oct 19, 1981
NML CK-MB RIA
K812759 · JHX
Nuclear Medical Laboratories, Inc.
Chemistry · 18d
Cleared Oct 19, 1981
PERITONEAL DIALYSIS DRAINAGE
K812771 · KDJ
Dravon Medical, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 19, 1981
PERITONEAL DIALYSIS CYCLER SET (8UNIT)
K812772 · KDJ
Dravon Medical, Inc.
Gastroenterology & Urology · 14d