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
37201–37224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2014
DUAL SHOT ALPHA 7
K133189 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 256d
Cleared Jun 30, 2014
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION...
K133575 · MNH
Spinevision S.A.
Orthopedic · 222d
Cleared Jun 30, 2014
SHUNTONG
K140243 · LYZ
Shuntong Glove Co., Ltd.
General Hospital · 151d
Cleared Jun 30, 2014
EXACTECH TAPERED WEDGE FEMORAL STEM
K140674 · LZO
Exactech, Inc.
Orthopedic · 104d
Cleared Jun 30, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K140751 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 97d
Cleared Jun 30, 2014
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
K140833 · JWH
Conformis, Inc.
Orthopedic · 89d
Cleared Jun 30, 2014
MBD PLATE SYSTEM
K141045 · HRS
Mbd Medical, LLC
Orthopedic · 68d
Cleared Jun 30, 2014
BICARBONATE CALIBRATOR
K141374 · JIT
Beckman Coulter Ireland, Inc.
Chemistry · 34d
Cleared Jun 30, 2014
DELTA TT ACETABULAR SYSTEM
K141395 · LPH
Lima Corporate S.P.A.
Orthopedic · 33d
Cleared Jun 30, 2014
PRECICE TRAUMA NAIL SYSTEM
K141447 · HSB
Ellipse Technologies, Inc.
Orthopedic · 28d
Cleared Jun 27, 2014
HICUT HIGHSPEED INSTRUMENT
K130755 · HBE
Adeor Medical AG
Neurology · 465d
Cleared Jun 27, 2014
EUROIMMUN ANTI-PLA2R ELISA (IGG)
K132195 · PGV
Euroimmun Us, Inc.
Immunology · 347d
Cleared Jun 27, 2014
MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE...
K133260 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 247d
Cleared Jun 27, 2014
PERICAN ULTRA
K133632 · BSP
B.Braun Medical, Inc.
Anesthesiology · 213d
Cleared Jun 27, 2014
SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER
K133843 · LIT
Cordis Corporation
Cardiovascular · 191d
Cleared Jun 27, 2014
PARI-PATH SURGICAL NAVIGATION SYSTEM
K133901 · JAK
Paritic, Inc.
Radiology · 189d
Cleared Jun 27, 2014
BIODENTINE
K140132 · KIF
Septodont
Dental · 161d
Cleared Jun 27, 2014
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
K140289 · KCT
Summit Medical, Inc.
General Hospital · 142d
Cleared Jun 27, 2014
NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER
K140542 · KMA
Rhinosystems, Inc.
Ear, Nose, Throat · 115d
Cleared Jun 27, 2014
HIVOX ELECTRIC STIMULATOR OTC TENS
K140650 · NUH
Hivox Biotek, Inc.
Neurology · 106d
Cleared Jun 27, 2014
NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG
K140701 · OQG
Novosource, Inc.
Orthopedic · 99d
Cleared Jun 27, 2014
P-STIM
K140788 · BWK
Biegler GmbH
Neurology · 88d
Cleared Jun 27, 2014
SURGICAL NAVIGATION ADVANCED PLATFORM
K140819 · LLZ
Surgical Theater, LLC
Radiology · 87d
Cleared Jun 27, 2014
PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER
K140823 · IYE
Varian Medical Systems, Inc.
Radiology · 87d