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
164929–164952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE AP2090V
K802733 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 710
K802734 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 740AP
K802735 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COOLECTION BAG TYPE 2090V
K802736 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 1590V
K802737 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 1505V
K802738 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 710AP
K802739 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
LOMATUELL OINTMENT DRESSING
K802793 · NAE
Secol Co.
General & Plastic Surgery · 44d
Cleared Dec 18, 1980
GAMBRO PERITONEAL DIALYSIS MONITOR
K802831 · KPF
Gambro, Inc.
Gastroenterology & Urology · 36d
Cleared Dec 18, 1980
DIGOXIN RADIOIMMUNOASSAY KIT
K802841 · DNL
American Diagnostic Corp.
Toxicology · 36d
Cleared Dec 18, 1980
SINGLE VIAL LIPASE TEST KIT
K802842 · CHI
Biodynamics Corp.
Chemistry · 36d
Cleared Dec 18, 1980
CLEANSER, ROOT CANAL
K802853 · KJJ
Dentsply Intl.
Dental · 35d
Cleared Dec 18, 1980
SAFE T COUNT
K802865 · KDC
Instranetics, Inc.
General & Plastic Surgery · 36d
Cleared Dec 17, 1980
THE VITA 2 DISPOSABLE DIALYZER
K801634 · FHS
Bellco Artifidial Organ Spec., Inc.
Gastroenterology & Urology · 155d
Cleared Dec 17, 1980
LEWIS TRAPEZO METACARPAL PROSTHESIS
K802106
Howmedica Corp.
Orthopedic · 105d
Cleared Dec 17, 1980
F110 PHOTO BINOCULAR OPHTHALMOSCOPE
K802351 · HLG
Minami, Tomine & Lew
Ophthalmic · 83d
Cleared Dec 17, 1980
METRICON #120 FLUOROPHOTOMETER
K802355 · HJO
Metricon, Ltd.
Ophthalmic · 83d
Cleared Dec 17, 1980
LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.
K802381 · HQC
Fibra Sonics, Inc.
Ophthalmic · 79d
Cleared Dec 17, 1980
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
K802651 · HQG
Chiron Vision Corp.
Ophthalmic · 54d
Cleared Dec 17, 1980
SILANIT
K802679 · EBG
Vivadent (Usa), Inc.
Dental · 50d
Cleared Dec 17, 1980
BLENDED BIFOCAL
K802749 · HQG
Robinson-Houchin, Inc.
Ophthalmic · 44d
Cleared Dec 17, 1980
POROPLAST-EYE DRESSING
K802786 · HOY
Secol Co.
Ophthalmic · 43d
Cleared Dec 17, 1980
METALLINE DRESSINGS
K802787 · KKX
Secol Co.
General Hospital · 43d
Cleared Dec 17, 1980
ZINC PASTE BANDAGE
K802791 · FRO
Secol Co.
General & Plastic Surgery · 43d