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
37225–37248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2014
A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR
K141179 · DXN
A & D Co., Ltd.
Cardiovascular · 51d
Cleared Jun 27, 2014
CRC PC WITH SMART CHAMBER
K141413 · KPT
Capintec, Inc.
Radiology · 29d
Cleared Jun 27, 2014
MDMC-12133
K141428 · PGY
Barco N.V.
Radiology · 28d
Cleared Jun 27, 2014
DEVON CIRONA 6200 DVT
K141578 · JOW
Devon Medical
Cardiovascular · 14d
Cleared Jun 26, 2014
DIAMOND RATTLESNAKE SYSTEM
K133194 · KWQ
Eminent Spine
Orthopedic · 252d
Cleared Jun 26, 2014
CONSURE STOOL MANAGEMENT SYSTEM
K133465 · KNT
Consure Medical Pvt , Ltd.
Gastroenterology & Urology · 226d
Cleared Jun 26, 2014
MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
K133579 · MBI
Pontis Orthopaedics, LLC
Orthopedic · 217d
Cleared Jun 26, 2014
SURESIGNS VS3, SURESIGNS VS4
K133961 · DSJ
Philips Medical Systems
Cardiovascular · 184d
Cleared Jun 26, 2014
KANGLI PEDICLE SCREW SPINAL SYSTEM
K140053 · MNH
Suzhou Kangli Orthopaedics Instrument...
Orthopedic · 168d
Cleared Jun 26, 2014
MEDLEY GOLD
K140435 · LRK
American Dental Sleep Medicine, Ip, LLC
Dental · 125d
Cleared Jun 26, 2014
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
K140588 · FXY
Stryker Corporation
General Hospital · 111d
Cleared Jun 26, 2014
COROENT THORACOLUMBAR IMPLANTS
K140659 · MAX
Nu Vasive, Incorporated
Orthopedic · 104d
Cleared Jun 26, 2014
LUNERAY
K140803 · JAQ
Nucletron B.V.
Radiology · 87d
Cleared Jun 26, 2014
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K141002 · HRX
Visionsense, Ltd.
Orthopedic · 69d
Cleared Jun 26, 2014
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
K141346 · LMC
Sony Electronics, Inc.
Radiology · 35d
Cleared Jun 26, 2014
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE...
K141376 · MNH
Nexxt Spine, LLC
Orthopedic · 30d
Cleared Jun 26, 2014
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
K141397 · MNI
Precision Spine, Inc.
Orthopedic · 29d
Cleared Jun 26, 2014
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
K141454 · LMC
Sony Electronics, Inc.
Radiology · 24d
Cleared Jun 25, 2014
ABSOLUTE DENTIN 2
K132115 · EBF
Parkell, Inc.
Dental · 351d
Cleared Jun 25, 2014
IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM
K132180 · NBW
Ideal Life, Inc.
Chemistry · 345d
Cleared Jun 25, 2014
BONDILOXS TOPICAL HEMOSTATIC DRESSING
K132333 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 334d
Cleared Jun 25, 2014
SATURNO(TM) OVERDENTURE IMPLANT SYSTEM
K133327 · DZE
Zest Anchors, LLC
Dental · 239d
Cleared Jun 25, 2014
RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK
K133848 · LNH
Heartvista, Inc.
Radiology · 189d
Cleared Jun 25, 2014
MASIMO ROOT MONITORING SYSTEM
K140188 · MWI
Masimo Corporation
Cardiovascular · 152d