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

Filters: Cleared only ×
175,820 results
124273–124296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1990
QMS TM- PHENYTOIN
K904815 · DIP
Seradyn, Inc.
Chemistry · 13d
Cleared Nov 05, 1990
NELATON-, FEMALE - OR TIEMANN CATHETER
K896729 · KOD
Unoplast A/S
Gastroenterology & Urology · 340d
Cleared Nov 05, 1990
MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)
K900720 · DSI
Mortara Instrument, Inc.
Cardiovascular · 264d
Cleared Nov 05, 1990
WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC
K901015 · DPW
Wright Medical Corp.
Cardiovascular · 245d
Cleared Nov 05, 1990
MONOHAEM (FECAL OCCULT BLOOD TEST)
K901064 · KHE
Silenus Laboratories Proprietary , Ltd.
Hematology · 243d
Cleared Nov 05, 1990
TSRH SACRAL L-CONNECTOR
K901587 · KWP
Danek Medical, Inc.
Orthopedic · 215d
Cleared Nov 05, 1990
SAFEBRIS STERILE CIRCUMCISION KIT
K902119 · FHJ
Kedumin Kits, Ltd.
Obstetrics & Gynecology · 180d
Cleared Nov 05, 1990
MODULOCK POSTERIOR SPINAL FIXATION
K902397 · KWP
Zimmer, Inc.
Orthopedic · 159d
Cleared Nov 05, 1990
CDI (TM) SYSTEM 100 MONITORING SYSTEM
K902654 · DTY
3M Health Care, Ltd.
Cardiovascular · 143d
Cleared Nov 05, 1990
ARTERIAL BLOOD SAMPLING KIT
K902771 · DQO
Medex, Inc.
Cardiovascular · 137d
Cleared Nov 05, 1990
BACTTRAP
K903056 · CAH
Pharma Systems, Inc.
General Hospital · 117d
Cleared Nov 05, 1990
CHANLLENGE 1010 PATIENT KEY PROGRAM STATION
K903149 · IPF
Maximum Performance Technologies,...
Physical Medicine · 110d
Cleared Nov 05, 1990
SOLARSHIELDS ENCORE
K903487 · HQY
Dioptics
Ophthalmic · 97d
Cleared Nov 05, 1990
ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.
K903555 · DRX
Jason Marketing Co.
Cardiovascular · 90d
Cleared Nov 05, 1990
GASTROGRAPH
K903646 · FFT
Medics Instrument Corp.
Gastroenterology & Urology · 83d
Cleared Nov 05, 1990
MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
K903878 · HQQ
Mentor O & O, Inc.
Ophthalmic · 75d
Cleared Nov 05, 1990
TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO
K904091 · EJF
Lancer Orthodontics, Inc.
Dental · 60d
Cleared Nov 05, 1990
CHILDRENS SUNGLASSES
K904197 · HQY
Jasco Products Co., Inc.
Ophthalmic · 54d
Cleared Nov 05, 1990
KWIKMIX
K904225 · LHI
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 53d
Cleared Nov 05, 1990
PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT
K904334 · LJS
Pharmacia Deltec, Inc.
General Hospital · 45d
Cleared Nov 05, 1990
CEDIA(TM) PHENOBARBITAL ASSAY
K904413 · LAF
Microgenics Corp.
Toxicology · 40d
Cleared Nov 05, 1990
ELEGANCE PROLACTIN ELISA
K904483 · CFT
Bioclone Australia Pty , Ltd.
Chemistry · 34d
Cleared Nov 05, 1990
CAP-EVAC ADAPTER
K904803 · CBN
Logan, Inc.
Anesthesiology · 12d
Cleared Nov 05, 1990
MAGNUM
K904817 · ITI
Everest & Jennings, Inc.
Physical Medicine · 12d