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
115033–115056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1992
DIGISCAN 2
K924459 · IXK
Siemens Medical Solutions USA, Inc.
Radiology · 106d
Cleared Dec 17, 1992
ELITE TEST STRIPS GLUCOMETER
K924499 · CGA
Heraeus Kulzer, Inc.
Chemistry · 104d
Cleared Dec 17, 1992
DAVOL KNOT PUSHER
K924592 · GCJ
Davol, Inc.
General & Plastic Surgery · 98d
Cleared Dec 17, 1992
DELFIA DIGOXIN KIT
K924594 · KXT
Wallac OY
Toxicology · 98d
Cleared Dec 17, 1992
BLOOD GAS MIXTURE
K924795 · BXK
Gulf States Airgas
Anesthesiology · 85d
Cleared Dec 17, 1992
LUNG DIFFUSION GAS MIXTURE
K924796 · BXK
Gulf States Airgas
Anesthesiology · 85d
Cleared Dec 17, 1992
BI-N
K924828 · IZI
Xre Corp.
Radiology · 80d
Cleared Dec 17, 1992
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
K925151 · JJT
Bio-Rad
Chemistry · 65d
Cleared Dec 17, 1992
PHILIPS INTEGRIS H/HM SYSTEM
K925302 · IZF
Philips Medical Systems, Inc.
Radiology · 57d
Cleared Dec 17, 1992
BILIARY STONE DISLODGER
K925559 · LQR
Annex Medical, Inc.
Gastroenterology & Urology · 44d
Cleared Dec 17, 1992
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC
K925716 · IYB
Bennett X-Ray Corp.
Radiology · 35d
Cleared Dec 17, 1992
KODAK EKTASCAN SP CASSETTE
K925997 · IXJ
Eastman Kodak Company
Radiology · 20d
Cleared Dec 17, 1992
BARD LEG BAG HOLDER
K926035 · FAQ
C.R. Bard, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 15, 1992
LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
K911731 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 608d
Cleared Dec 15, 1992
ULTRALON POWDERFREE SURGICAL GLOVES
K915218 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 391d
Cleared Dec 15, 1992
LIFESHIELD VIAL ADAPTER
K920737 · FMI
Abbott Laboratories
General Hospital · 300d
Cleared Dec 15, 1992
FORCE 2
K921884 · HGI
Valleylab, Inc.
Obstetrics & Gynecology · 238d
Cleared Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
K922333 · LGC
Baxter Diagnostics, Inc.
Microbiology · 216d
Cleared Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA
K922334 · LGC
Baxter Diagnostics, Inc.
Microbiology · 216d
Cleared Dec 15, 1992
FIBERLIFE
K922807 · GEX
Laser Surgical Systems
General & Plastic Surgery · 188d
Cleared Dec 15, 1992
URESIL SPECIMEN RETRIEVAL BAG
K923219 · GCJ
Uresil Corp.
General & Plastic Surgery · 167d
Cleared Dec 15, 1992
BONE MARROW BIOPSY SYSTEM
K923872 · GDM
The Straumann Co.
General & Plastic Surgery · 134d
Cleared Dec 15, 1992
PATIENT EXAM GLOVES (POWDER FREE)
K923967 · LYY
American Health Products, Inc.
General Hospital · 131d
Cleared Dec 15, 1992
ZORBA(TM) IGG REMOVAL REAGENT
K924197 · DEW
Zeus Scientific, Inc.
Immunology · 117d