FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82177–82200 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2000
BIOSOFT RESIN
K001640 · EBI
Biosoft International Corp.
Dental · 46d
Cleared Jun 23, 2000
VARIS 1.4G
K001643 · IYE
Varian Medical Systems, Inc.
Radiology · 24d
Cleared Jun 23, 2000
STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234
K001649 · JOJ
Steritec Products, Inc.
General Hospital · 24d
Cleared Jun 23, 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · KKX
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Jun 23, 2000
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
K001672 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 22d
Cleared Jun 23, 2000
GALILEO VENTILATOR
K001686 · CBK
Hamilton Medical, Inc.
Anesthesiology · 36d
Cleared Jun 23, 2000
GEMINI E
K993623 · DQD
Allen Medical Instruments Corp.
Cardiovascular · 241d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST (THC)
K993663 · LDJ
Worldwide Medical Corp.
Toxicology · 238d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST PANEL 3
K994138 · LDJ
Worldwide Medical Corp.
Toxicology · 199d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST PANEL 2
K994139 · LDJ
Worldwide Medical Corp.
Toxicology · 199d
Cleared Jun 23, 2000
IL TEST LIQUID ANTITHROMBIN
K994238 · JBQ
Instrumentation Laboratory CO
Hematology · 190d
Cleared Jun 22, 2000
CRITERION 60 OR PM 60
K000959 · CAP
Caradyne, Ltd.
Anesthesiology · 90d
Cleared Jun 22, 2000
ANATOMIC TOTAL KNEE PROSTHESIS
K000978 · JWH
Biomet, Inc.
Orthopedic · 87d
Cleared Jun 22, 2000
BIPAP DUET LX BI-LEVEL SYSTEM
K000994 · BZD
Respironics, Inc.
Anesthesiology · 86d
Cleared Jun 22, 2000
CD HORIZON ECLIPSE
K001066 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 80d
Cleared Jun 22, 2000
ULTRASIM CT SYSTEM
K001088 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 79d
Cleared Jun 22, 2000
DBEST HCG 2 IU/ML TEST KIT
K001215 · JHI
Ameritek, Inc.
Chemistry · 69d
Cleared Jun 22, 2000
ORTHOCEPH OC100 D
K001439 · MUH
Instrumentarium Corp.
Radiology · 45d
Cleared Jun 22, 2000
NOVAC7
K990209 · IYE
Hitesys S.P.A.
Radiology · 518d
Cleared Jun 22, 2000
VASO PRESS DVT SYSTEM, MODELS VP500, VP501
K991038 · JOW
Britt Corp., Inc.
Cardiovascular · 451d
Cleared Jun 22, 2000
CLICKER
K994384 · KZE
Bioject, Inc.
General Hospital · 177d
Cleared Jun 22, 2000
AEQUALIS UNIVERSAL SHOULDER GLENOID
K994393 · KWS
Tornier
Orthopedic · 177d
Cleared Jun 21, 2000
BEHRING COAGULATION TIMER ANALYZER (BCT)
K001064 · JPA
Dade Behring, Inc.
Hematology · 79d
Cleared Jun 21, 2000
MEMOGRAPH
K001219 · JEY
Biomedical Ent., Inc.
Dental · 65d