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
81673–81696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 21, 2000
SERAGARD INJECTION PATCH
K001240 · KGX
Platinum Services, Inc.
General & Plastic Surgery · 64d
Cleared Jun 21, 2000
DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
K001269 · EJH
Dentalmatic Technologies, Inc.
Dental · 62d
Cleared Jun 21, 2000
PALCERAM 53
K001479 · EJT
Aurex SA (Pty) , Ltd.
Dental · 41d
Cleared Jun 21, 2000
AURECAST 40 B
K001480 · EJT
Aurex SA (Pty) , Ltd.
Dental · 41d
Cleared Jun 21, 2000
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
K001629 · FRN
Disetronic Medical Systems AG
General Hospital · 26d
Cleared Jun 21, 2000
MILLENNIA ACUPUNCTURE NEEDLE
K001718 · MQX
United Pacific Co., Ltd.
General Hospital · 16d
Cleared Jun 21, 2000
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
K001769 · CGX
Ortho-Clinical Diagnostics
Chemistry · 9d
Cleared Jun 21, 2000
TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
K001786 · DZE
Sulzer Calcitek, Inc.
Dental · 8d
Cleared Jun 21, 2000
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
K992606 · HLI
Canon USA, Inc.
Ophthalmic · 323d