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
77113–77136 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2001
ANISEIKONIA INSPECTOR
K013110 · HJT
Optical Diagnostics, Inc.
Ophthalmic · 161d
Cleared Dec 19, 2001
MICROGYN PLUS STIMULATION DEVICE
K013141 · KPI
Hollister, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 19, 2001
MULTITAK SUTURE SNAP SYSTEM
K013177 · GAM
Bonutti Research, Inc.
General & Plastic Surgery · 86d
Cleared Dec 19, 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Dec 19, 2001
BLUE LATEX EXAMINATION GLOVES, POWDER FREE
K013320 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 75d
Cleared Dec 19, 2001
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
K013346 · LYC
W.L. Gore & Associates, Inc.
Dental · 71d
Cleared Dec 19, 2001
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
K013449 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 63d
Cleared Dec 19, 2001
AUROFLUID PLUS
K013505 · EJT
Metalor Technologies USA
Dental · 58d
Cleared Dec 19, 2001
PRE-LOADED ULTRAFIX RC
K013553 · MBI
Linvatec Corp.
Orthopedic · 55d
Cleared Dec 19, 2001
POLARUS CAP SCREW
K013616 · HSB
Acu Med, Inc.
Orthopedic · 44d
Cleared Dec 19, 2001
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K013798 · DZE
Institut Straumann AG
Dental · 34d
Cleared Dec 19, 2001
XIA SPINAL SYSTEM
K013823 · KWP
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 19, 2001
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Dec 19, 2001
AUTO SUTURE SURGICAL STAPLES
K013860 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Dec 19, 2001
CODMAN SLIM-LOC SYSTEM
K013877 · KWQ
Codman & Shurtleff, Inc.
Orthopedic · 26d
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · LZO
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Dec 19, 2001
GENERATION 4 BONE CEMENT
K993836 · LOD
Biomet, Inc.
Orthopedic · 768d
Cleared Dec 18, 2001
SHAPEABLE DOPPLER FLOW PROBE
K002958 · ITX
Cook Vascular, Inc.
Radiology · 452d
Cleared Dec 18, 2001
HOME-AWAY SYSTEM
K004047 · CAW
In-X Corp.
Anesthesiology · 354d
Cleared Dec 18, 2001
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K010925 · CBK
Siemens Elema AB
Anesthesiology · 266d
Cleared Dec 18, 2001
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
K011907 · DWJ
Sims Level 1, Inc.
Cardiovascular · 183d
Cleared Dec 18, 2001
RAMP MYOGLOBIN ASSAY
K012040 · DDR
Response Biomedical Corp.
Chemistry · 172d
Cleared Dec 18, 2001
NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
K012088 · KNW
Nastech Pharmaceutical Company, Inc.
Gastroenterology & Urology · 168d
Cleared Dec 18, 2001
NO STEP ON SITE DEUG TEST CUP
K012390 · LDJ
Drug Free Enterprises
Toxicology · 144d