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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
36553–36576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2014
ELITE + LASER SYSTEM
K141425 · GEX
Cynosure, Inc.
General & Plastic Surgery · 104d
Cleared Sep 11, 2014
IASSIST KNEE SYSTEM
K141601 · OLO
Zimmer Cas
Orthopedic · 87d
Cleared Sep 10, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130742 · LYZ
Dahoon Plastic Co., Ltd.
General Hospital · 540d
Cleared Sep 10, 2014
ITRAC CERVICAL TRACTION SYSTEM
K131983 · ITH
Pivotal Health Solutions
Physical Medicine · 439d
Cleared Sep 10, 2014
BTL-9000
K134040 · OLI
Btl Industries, Ltd.
General & Plastic Surgery · 253d
Cleared Sep 10, 2014
RENAISSANCE X SYSTEM
K140167 · OLO
Mazor Robotics , Ltd.
Orthopedic · 230d
Cleared Sep 10, 2014
SURGICAL DRAPE
K140195 · KKX
Griffith-Lucas, LLC
General Hospital · 226d
Cleared Sep 10, 2014
TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS
K140390 · MBF
Biomet Manufacturing Corp
Orthopedic · 208d
Cleared Sep 10, 2014
CONTACT LENS CASE
K140488 · LRX
Maca Plastics, Inc.
Ophthalmic · 195d
Cleared Sep 10, 2014
KEGEL SMART, KEGELSMART PEARL
K140780 · HIR
Regulatory Insight, Inc.
Gastroenterology & Urology · 166d
Cleared Sep 10, 2014
TABLO CONSOLE
K140866 · KDI
Home Dialysis Plus
Gastroenterology & Urology · 160d
Cleared Sep 10, 2014
NOVAGUARD S A SAFETY SYSTEM
K141464 · MEG
West Pharmaceutical Services
General Hospital · 99d
Cleared Sep 10, 2014
GLOBE-TROTTER GT5400
K141565 · FPL
Draeger Medical Systems, Inc.
General Hospital · 90d
Cleared Sep 10, 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835 · MNI
Spineart
Orthopedic · 65d
Cleared Sep 10, 2014
TRIDENT FUSION IMPLANT
K141937 · HWC
Vilex IN Tennessee, Inc.
Orthopedic · 55d
Cleared Sep 10, 2014
VIA SPINOUS PROCESS FIXATION SYSTEM
K142213 · PEK
Spineology, Inc.
Orthopedic · 29d
Cleared Sep 10, 2014
Apollo Suture Anchor System and Titan Screws
K142230 · MBI
Valeris Medical
Orthopedic · 28d
Cleared Sep 10, 2014
Direxion Torqueable Microcatheter
K142259 · KRA
Boston Scientific Corp
Cardiovascular · 27d
Cleared Sep 10, 2014
EyeSuite Imaging
K142423 · NFJ
Haag-Streit AG
Ophthalmic · 13d
Cleared Sep 09, 2014
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K131340 · LYZ
Made Plastic Co., Ltd.
General Hospital · 488d
Cleared Sep 09, 2014
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
K133963 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 259d
Cleared Sep 09, 2014
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976 · FCX
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 257d
Cleared Sep 09, 2014
ZEISS CATARACT SUITE MARKERLESS
K141068 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 138d
Cleared Sep 09, 2014
SPACELABS HEALTHCARE TELEMETRY RECEIVER
K141156 · MHX
Spacelabs Healthcare
Cardiovascular · 127d