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
124489–124512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1990
BAUER TEMNO BIOPSY NEEDLE
K902319 · FCG
Proact, Ltd.
Gastroenterology & Urology · 106d
Cleared Sep 06, 1990
SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*
K902348 · FYA
Futuristic Medical Concepts, Inc.
General Hospital · 104d
Cleared Sep 06, 1990
HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL
K902645 · DZB
Ormco Corp.
Dental · 83d
Cleared Sep 06, 1990
HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP
K902646 · DZB
Ormco Corp.
Dental · 83d
Cleared Sep 06, 1990
DENTURE DYNAMIC'S DENTURE MAGIC
K902838 · EFT
Denture Dynamic'S, Inc.
Dental · 70d
Cleared Sep 06, 1990
TI-CORE (DENTAL COMPOSITE)
K902893 · EBF
Medical Device Inspection Co., Inc.
Dental · 66d
Cleared Sep 06, 1990
TITANIUM/STAINLESS STEEL INSTRUMENTS
K902911 · DZE
Impla-Med
Dental · 66d
Cleared Sep 06, 1990
ANTI-SCI-70 MICROASSAY
K902915 · LJM
Diamedix Corp.
Immunology · 65d
Cleared Sep 06, 1990
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K903008 · EJH
Vident
Dental · 57d
Cleared Sep 06, 1990
OLIVE K-WIRES
K903105 · JEC
Danek Medical, Inc.
Orthopedic · 63d
Cleared Sep 06, 1990
ELECTROMEDICS BT422-120 AND BT422-40
K903392 · CAC
Electromedics, Inc.
Anesthesiology · 41d
Cleared Sep 06, 1990
SMALL JOINT INSTRUMENTS (SCISSOR HANDLE)
K903536 · LOS
Leonard Medical, Inc.
Cardiovascular · 30d
Cleared Sep 06, 1990
ARGENCO 9
K903548 · EJT
Argen Precious Metals, Inc.
Dental · 31d
Cleared Sep 06, 1990
ARGENCO 25
K903549 · EJT
Argen Precious Metals, Inc.
Dental · 30d
Cleared Sep 06, 1990
ARGIDENT 2A DENTAL GOLD ALLOY FOR PORECLAIN
K903677 · EJT
Argen Precious Metals, Inc.
Dental · 24d
Cleared Sep 06, 1990
DISPENSA-LUBE
K903717 · KMJ
Gam-Med Packaging Corp.
General Hospital · 23d
Cleared Sep 05, 1990
SPIRTOS COAXIAL CATHETER SET
K896524 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 294d
Cleared Sep 05, 1990
CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR
K896652 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 285d
Cleared Sep 05, 1990
(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000
K901253 · DTZ
Bio Medicus, Inc.
Cardiovascular · 173d
Cleared Sep 05, 1990
DUAL PORT
K901419 · LJT
Infusaid Corp.
General Hospital · 163d
Cleared Sep 05, 1990
VISION DIAGNOSTIC ULTRASONIC SCANNER
K901467 · IYO
The Probe Corp.
Radiology · 160d
Cleared Sep 05, 1990
AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
K901641 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 149d
Cleared Sep 05, 1990
LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)
K901835 · KNT
Lake Medical Products, Inc.
Gastroenterology & Urology · 139d
Cleared Sep 05, 1990
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
K901972 · LJC
Novo Nordisk Diagnostics, Ltd.
Microbiology · 127d