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
123745–123768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1990
SCOPESCRUBBER(TM)
K902683 · EOB
Healthtek Microsurgical, Inc.
Ear, Nose, Throat · 134d
Cleared Oct 31, 1990
PRIZM HEARING SYSTEM
K902846 · ESD
Audioscience, Inc.
Ear, Nose, Throat · 125d
Cleared Oct 31, 1990
HME-10 (TM)
K903054 · BYD
Pharma Systems, Inc.
Anesthesiology · 112d
Cleared Oct 31, 1990
GERARD MEDICAL, INC. TRIM-PORT
K903364 · LJT
Gerard Medical Enterprises, Inc.
General Hospital · 97d
Cleared Oct 31, 1990
BIO-MEDICUS CANNULA INTRODUCER
K903410 · DYB
Bio Medicus, Inc.
Cardiovascular · 92d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U
K903747 · GDM
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V
K903748 · GDM
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U
K903749 · GDM
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E
K903750 · GDM
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
K903816 · EZK
Respiratory Support Products, Inc.
Gastroenterology & Urology · 72d
Cleared Oct 31, 1990
MODEL 1850 ELECTRODE
K903918 · DRX
Medtronic Vascular
Cardiovascular · 68d
Cleared Oct 31, 1990
ELLA BREAST FORM
K904085 · KCZ
Coloplast A/S
General & Plastic Surgery · 56d
Cleared Oct 31, 1990
SENSATRACE
K904185 · DRX
Ludlow Corp., Technical Papers Division
Cardiovascular · 49d
Cleared Oct 31, 1990
SUCTION SYSTEM
K904218 · GEA
Axiom Medical, Inc.
General & Plastic Surgery · 49d
Cleared Oct 31, 1990
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
K904273 · LTZ
Carter Products
Obstetrics & Gynecology · 44d
Cleared Oct 31, 1990
ARGENCO 22
K904343 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Oct 31, 1990
ARGILITE 3
K904467 · EIT
Argen Precious Metals, Inc.
Dental · 30d
Cleared Oct 31, 1990
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
K904544 · EWO
Qualitone
Ear, Nose, Throat · 27d
Cleared Oct 31, 1990
MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN
K904701 · BYX
Medical Fittings, Inc.
Anesthesiology · 15d
Cleared Oct 31, 1990
MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS
K904702 · BYX
Medical Fittings, Inc.
Anesthesiology · 15d
Cleared Oct 31, 1990
OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS
K904757 · BYX
Medical Fittings, Inc.
Anesthesiology · 12d
Cleared Oct 31, 1990
TKO TELESCOPING LITHOTOMY STIRRUP
K904826 · FWZ
D.L. Nelson and Assoc., Inc.
General & Plastic Surgery · 6d
Cleared Oct 30, 1990
LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER
K902056 · JDY
Hollister, Inc.
Orthopedic · 176d
Cleared Oct 30, 1990
FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM
K902149 · FKX
Fresenius/Delmed, Inc.
Gastroenterology & Urology · 168d