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
38137–38160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2014
RADIANCE 330 PROTON THERAPY SYSTEM
K134052 · LHN
Protom International, Inc.
Radiology · 73d
Cleared Mar 14, 2014
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K140345 · LJS
C.R. Bard, Inc.
General Hospital · 31d
Cleared Mar 14, 2014
LUMENIS PULSE 120H
K140388 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 28d
Cleared Mar 13, 2014
INTENSIF
K130501 · OUH
Endymed Medical, Ltd.
General & Plastic Surgery · 379d
Cleared Mar 13, 2014
ULTRACONGRUENT INSERT
K132752 · JWH
United Orthopedic Corporation
Orthopedic · 191d
Cleared Mar 13, 2014
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
K133005 · GGP
Instrumentation Laboratory CO
Hematology · 169d
Cleared Mar 13, 2014
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
K133015 · KCT
Summit Medical, Inc.
General Hospital · 169d
Cleared Mar 13, 2014
E-Z LINK
K133097 · LHI
Duoject Medical Systems, Inc.
General Hospital · 164d
Cleared Mar 13, 2014
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 146d
Cleared Mar 13, 2014
ARSENAL SPINAL FIXATION SYSTEM
K133221 · NKB
Alphatec Spine, Inc.
Orthopedic · 146d
Cleared Mar 13, 2014
OMNI ARC MONOBLOCK HIP STEM
K133381 · LZO
Omnilife Science
Orthopedic · 129d
Cleared Mar 13, 2014
MALLEABLE SUCTION INSTRUMENTS
K133665 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 104d
Cleared Mar 13, 2014
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
K133764 · FRO
Avery Dennison Belgie Bvba
General & Plastic Surgery · 92d
Cleared Mar 13, 2014
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
K133832 · LPH
Total Joint Orthopedics, Inc.
Orthopedic · 86d
Cleared Mar 13, 2014
EMERGE MEDICAL DISTAL RADIUS SET
K140107 · HRS
Emerge Medical
Orthopedic · 57d
Cleared Mar 13, 2014
CD HORIZON SPINAL SYSTEM
K140276 · OSH
Medtronic Sofamor Danek
Orthopedic · 38d
Cleared Mar 12, 2014
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
K130981 · FGE
Cordis Corp.
Gastroenterology & Urology · 337d
Cleared Mar 12, 2014
BODIHEALTH SYSTEM
K131675 · GZJ
Eprt Technologies, Inc.
Neurology · 278d
Cleared Mar 12, 2014
SNAP WOUND CARE SYSTEM
K132080 · OKO
Spiracur, Inc.
General & Plastic Surgery · 250d
Cleared Mar 12, 2014
STELLARIS PC VISION ENHANCEMENT SYSTEM
K133486 · HQC
Bausch & Lomb
Ophthalmic · 119d
Cleared Mar 12, 2014
POLARIS SPINAL SYSTEM
K133746 · NKB
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 93d
Cleared Mar 12, 2014
SURGISLEEVE WOUND PROTECTOR
K140064 · KKX
Covidien
General Hospital · 61d
Cleared Mar 12, 2014
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
K140098 · HRS
Emerge Medical
Orthopedic · 57d
Cleared Mar 12, 2014
EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
K140119 · HRS
Emerge Medical
Orthopedic · 55d