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
160705–160728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1982
SPECTRA305
K820492 · FTC
Ultralite
General & Plastic Surgery · 36d
Cleared Mar 31, 1982
LASER GAS MIXTURES
K820535 · EWG
Union Carbide Corp.
Toxicology · 29d
Cleared Mar 31, 1982
XENAMATIC SERIES OF XENON REBREATH DEV
K820571 · IYT
Diversified P.A.
Radiology · 29d
Cleared Mar 31, 1982
TENSOPLAST SKIN TRACTION KIT
K820612 · HST
Smith & Nephew, Inc.
Neurology · 23d
Cleared Mar 31, 1982
ARRANGE TM
K820688 · JAK
General Electric Co.
Radiology · 19d
Cleared Mar 31, 1982
COBE PPD 1.3L, #18-520-009
K820694 · FJG
Cobe Laboratories, Inc.
Gastroenterology & Urology · 19d
Cleared Mar 31, 1982
DELTA PLAN II RADIATION THERAPY PLANNING SYSTEM
K827122
Technicare Corp.
Radiology · 54d
Cleared Mar 31, 1982
ARS-1000 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K827175
Applied Radiation
Radiology · 41d
Cleared Mar 26, 1982
SHEFFIELD INFANT VENTILATOR MARK 4
K812961 · CBK
Cairco , Ltd.
Anesthesiology · 156d
Cleared Mar 26, 1982
REUSABLE & DISPOSABLE TEMP. PROBES
K813459 · FLL
Electromedics, Inc.
General Hospital · 115d
Cleared Mar 26, 1982
CENTRIA PROLACTIN TEST SET
K813572 · CFT
Ventrex Laboratories, Inc.
Chemistry · 94d
Cleared Mar 26, 1982
CARDIOVASCULAR TEMP. PACEMAKER ELEC
K820003 · LDF
Diag Corp.
Cardiovascular · 81d
Cleared Mar 26, 1982
RESUSCITATION MASK
K820059 · BTM
Cederroth, Inc. USA
Anesthesiology · 74d
Cleared Mar 26, 1982
GORE-TEX TISSUE REINFORCEMENT PATCH
K820193 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 60d
Cleared Mar 26, 1982
RETRIEVAL FORCEPS
K820239 · KOD
American Endoscopy, Inc.
Gastroenterology & Urology · 56d
Cleared Mar 26, 1982
PAPILLOTOMES
K820240 · KNS
American Endoscopy, Inc.
Gastroenterology & Urology · 56d
Cleared Mar 26, 1982
ADAPTAID TEMP. PACING EXT. LEAD #366-02
K820268 · DSA
Intermedics, Inc.
Cardiovascular · 52d
Cleared Mar 26, 1982
FOLLICLE STIMULATING HORMONE KIT
K820358 · CGJ
Pcl-Ria, Inc.
Chemistry · 45d
Cleared Mar 26, 1982
MARK 500 ULTRASOUOND SYSTEM
K820364 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 45d
Cleared Mar 26, 1982
MARK 100 & 300 ULTRASOUND SYSTEM
K820365 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 45d
Cleared Mar 26, 1982
JLS GROUP INFANT MONITOR
K820374 · BZQ
Jls Group, Inc.
Anesthesiology · 45d
Cleared Mar 26, 1982
AVES WRIGHT STAIN
K820437 · IAF
Helena Laboratories
Pathology · 37d
Cleared Mar 26, 1982
THROMBOSCREEN
K820450 · GIT
Pacific Hemostasis
Hematology · 36d
Cleared Mar 26, 1982
INTRODUCER FOR ENDOTRACHEAL TUBE
K820451 · BWB
Imed Corp.
Anesthesiology · 36d