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
111241–111264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1993
INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
K934039 · LBR
Intersect Systems, Inc.
Chemistry · 90d
Cleared Nov 16, 1993
OLYMPUS CREATININE REAGENT
K934361 · CGX
Olympus Corp.
Chemistry · 69d
Cleared Nov 15, 1993
BONE DRILLS OR TAPS
K914714 · DZE
Implant Corp. of America
Dental · 759d
Cleared Nov 15, 1993
CUTIFILM(R) FILM
K926399 · MGP
Beiersdorf, Inc.
General & Plastic Surgery · 329d
Cleared Nov 15, 1993
VICTOREEN MODEL 530
K931927 · IYE
Victoreen, Inc.
Radiology · 213d
Cleared Nov 15, 1993
MAJOR, MINOR, BASIN TRAYS (PACKS)
K932217 · LRO
Associated Medical Products Co.
General & Plastic Surgery · 192d
Cleared Nov 15, 1993
ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)
K932732 · KXT
Dupont Medical Products
Toxicology · 161d
Cleared Nov 15, 1993
DISPOSABLE PENILE BLOOD PRESSURE CUFFS
K932851 · DXQ
D. E. Hokanson, Inc.
Gastroenterology & Urology · 158d
Cleared Nov 15, 1993
DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
K932876 · LKJ
Shield Diagnostics, Ltd.
Immunology · 154d
Cleared Nov 15, 1993
TAS ANALYZER
K933092 · GKP
Cardiovascular Diagnostic Services
Hematology · 144d
Cleared Nov 15, 1993
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR
K933400 · KOD
Kendall Healthcare Products Co....
Gastroenterology & Urology · 126d
Cleared Nov 15, 1993
STAGO FACTOR IX-DEFICIENT PLASMA
K933432 · GJT
American Bioproducts Co.
Hematology · 124d
Cleared Nov 12, 1993
DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM
K920689 · FSO
Deemed, Inc.
General & Plastic Surgery · 637d
Cleared Nov 12, 1993
OPTOSCALPEL I LASER SYSTEM
K923531 · HQB
Optomed Corp.
Ophthalmic · 484d
Cleared Nov 12, 1993
K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE
K924324 · FMZ
K-1 Medical Products, Inc.
General Hospital · 442d
Cleared Nov 12, 1993
AHMED GLAUCOMA VALVE IMPLANT
K925636 · KYF
New World Medical, Inc.
Ophthalmic · 368d
Cleared Nov 12, 1993
FORCEPS FOR LAPAROSCOPIC SURGERY GU USE
K925959 · GCJ
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 353d
Cleared Nov 12, 1993
NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE
K926016 · GCJ
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 347d
Cleared Nov 12, 1993
BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO
K926477 · GBW
Core Dynamics, Inc.
General & Plastic Surgery · 318d
Cleared Nov 12, 1993
BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO
K930060 · FYD
Buffalo Filter Co., Inc.
General Hospital · 310d
Cleared Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCULPA
K930063 · FYD
Buffalo Filter Co., Inc.
General Hospital · 310d
Cleared Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCR0030
K930064 · FYD
Buffalo Filter Co., Inc.
General Hospital · 310d
Cleared Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCR0043
K930065 · FYD
Buffalo Filter Co., Inc.
General Hospital · 310d
Cleared Nov 12, 1993
BUFFALO FILTER REPLACEMENT FILTER #BCCHAR
K930066 · FYD
Buffalo Filter Co., Inc.
General Hospital · 310d