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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
116473–116496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1992
FORTRESS 1704FS FOUR WHEEL SCOOTER
K922966 · INI
Fortress Scientific , Ltd.
Physical Medicine · 45d
Cleared Aug 03, 1992
FORTRESS 1700FS REAR WHEEL DRIVE SCOOTER
K922967 · INI
Fortress Scientific , Ltd.
Physical Medicine · 45d
Cleared Aug 03, 1992
ND:YAG LASER-12
K923050 · GEX
Laser Endo Technic
General & Plastic Surgery · 40d
Cleared Aug 03, 1992
DANNINFLEX CPM 800
K923216 · BXB
Buckman Co., Inc.
Physical Medicine · 33d
Cleared Aug 03, 1992
DANNIFLEX CPM 2000
K923217 · BXB
Buckman Co., Inc.
Physical Medicine · 33d
Cleared Aug 03, 1992
PEEP VALVE
K923618 · BYE
International Respiratory Systems, Inc.
Anesthesiology · 13d
Cleared Jul 30, 1992
LEGIONELLA STAT IGG/IGM TEST KIT
K911356 · MJH
Whittaker Bioproducts, Inc.
Microbiology · 490d
Cleared Jul 30, 1992
MEDRAD MCT-PLUS INJECTOR
K913624 · DXT
Medrad, Inc.
Cardiovascular · 352d
Cleared Jul 30, 1992
FIBEROPTIC TYMPANIC THERMOMETER, MODEL 6000
K914005 · FLL
Daily Medical Products, Inc.
General Hospital · 328d
Cleared Jul 30, 1992
ZIRCONIUM ALLOY FRMORAL HEAD
K914878 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 274d
Cleared Jul 30, 1992
MERIT ADMINISTRATION SET
K915678 · FPA
Merit Medical Systems, Inc.
General Hospital · 224d
Cleared Jul 30, 1992
PERMIER HISTOPLASMA
K915700 · MIZ
Meridian Diagnostics, Inc.
Microbiology · 220d
Cleared Jul 30, 1992
MODELS M1722A, M1723A, M1724A DEFIBRILLATORS
K915757 · DRO
Hewlett-Packard Co.
Cardiovascular · 220d
Cleared Jul 30, 1992
SYNTHETIC ABSORBABLE SUTURE, UNDYED
K920437 · GAW
Ethicon, Inc.
General & Plastic Surgery · 178d
Cleared Jul 30, 1992
3D TOF ANGIOGRAPHY MEASURING FUNCTION
K920441 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 178d
Cleared Jul 30, 1992
AFFIRM VP SAMPLE COLLECTION SET
K920536 · LIO
Microprobe Corp.
Microbiology · 176d
Cleared Jul 30, 1992
WOODLYN CLASSIC LENSMETER
K920861 · HLM
Woodlyn, Inc.
Ophthalmic · 156d
Cleared Jul 30, 1992
GAELTEC MPR SERIES
K921062 · FFX
Medical Measurements, Inc.
Gastroenterology & Urology · 147d
Cleared Jul 30, 1992
ULTRABLADE
K921167 · GDX
Micron Technology, Inc.
General & Plastic Surgery · 141d
Cleared Jul 30, 1992
MODEL 654 ANALYZER
K921403 · JIH
Ciba Corning Diagnostics Corp.
Chemistry · 128d
Cleared Jul 30, 1992
TURKEL THORACENTESIS NEEDLE
K921461 · GSS
Symbiosis Corp.
Microbiology · 125d
Cleared Jul 30, 1992
HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
K921745 · JFH
Hybritech, Inc.
Chemistry · 108d
Cleared Jul 30, 1992
MODIFICATION TO IV SPIKE
K921860 · FPA
Mcgaw, Inc.
General Hospital · 141d
Cleared Jul 30, 1992
CDH HIP SYSTEM
K922008 · JDI
Howmedica, Pfizer Medical Technology...
Orthopedic · 91d