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
35449–35472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2015
iMAR
K142584 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Jan 16, 2015
All Safe Huber Safety Infusion Set
K142590 · FPA
Nexus Medical, LLC
General Hospital · 123d
Cleared Jan 16, 2015
PRECISE Trauma Nail System
K142599 · HSB
Ellipse Technologies, Incorporated
Orthopedic · 123d
Cleared Jan 16, 2015
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
K142862 · LZA
Careplus (M) Sdn Bhd
General Hospital · 107d
Cleared Jan 16, 2015
P200DTx
K142897 · MYC
Optos Plc.
Ophthalmic · 105d
Cleared Jan 16, 2015
SpyGlass DS Direct Visualization System
K142922 · FBN
Boston Scientific Corporation
Gastroenterology & Urology · 100d
Cleared Jan 16, 2015
Proficient (TM) Facet Screw Spine System
K142980 · MRW
Spine Wave, Inc.
Orthopedic · 93d
Cleared Jan 16, 2015
GUARDIAN-SG Inflatable Bone Expander System
K143006 · NDN
Bm Korea Co., Ltd.
Orthopedic · 88d
Cleared Jan 16, 2015
Nitinol Compression Plating System
K143023 · HRS
Biomedical Enterprises, Inc.
Orthopedic · 87d
Cleared Jan 16, 2015
CrossRoads Screw System
K143039 · HWC
Orthodiscovery Group, LLC (D.B.A....
Orthopedic · 86d
Cleared Jan 16, 2015
Arthrex Fracture System
K143139 · HRS
Arthrex, Inc.
Orthopedic · 74d
Cleared Jan 16, 2015
Medline ReNewal Reprocessed Compression Limb Sleeves
K143166 · JOW
Surgical Instrument Service and...
Cardiovascular · 73d
Cleared Jan 16, 2015
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
K143190 · MVN
Yung Sheng Optical Co., Ltd.
Ophthalmic · 72d
Cleared Jan 16, 2015
Ultrasound Scanner System bk2300
K143298 · IYN
Bk Medical Aps
Radiology · 60d
Cleared Jan 16, 2015
Audit MicroControls Linearity FD Tumor Markers II
K143573 · JJY
Aalto Scientific, Ltd.
Immunology · 30d
Cleared Jan 16, 2015
GEM Flow COUPLER Device and System
K143589 · MVR
Synovis Life Technologies, Inc.
General & Plastic Surgery · 29d
Cleared Jan 16, 2015
Arthrex Low Profile Screws
K143614 · HWC
Arthrex, Inc.
Orthopedic · 28d
Cleared Jan 15, 2015
NEONATALIE RESUSCITATOR
K132172 · BTM
Laerdal Medical A/S
Anesthesiology · 549d
Cleared Jan 15, 2015
PRO X OTC 5
K140471 · OHS
La Lumiere, LLC
General & Plastic Surgery · 324d
Cleared Jan 15, 2015
GENASIS HIPATH IHC FAMILY
K140957 · NQN
Applied Spectral Imaging , Ltd.
Pathology · 276d
Cleared Jan 15, 2015
SUPER SHEATH
K141070 · DRE
Togo Medikit Co., Ltd.
Cardiovascular · 265d
Cleared Jan 15, 2015
IMPIX ALIF S/A
K141187 · OVD
Medicrea International SA
Orthopedic · 252d
Cleared Jan 15, 2015
JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K141224 · LYZ
Shijiazhunag Jiuyuan Plastic Co., Ltd.
General Hospital · 248d
Cleared Jan 15, 2015
SImmetry Sacroiliac Joint Fusion System
K141549 · OUR
Zyga Technology, Inc.
Orthopedic · 218d