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
38857–38880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2013
PRESSUREWIRE AERIS AGILE TIP
K133587 · DRG
St. Jude Medical Systems AB
Cardiovascular · 29d
Cleared Dec 20, 2013
BD MAX MRSA XT, BD MAX INSTRUMENT
K133605 · NQX
Geneohm Sciences Canada, Inc.
Microbiology · 25d
Cleared Dec 20, 2013
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K133626 · KRD
MicroVention, Inc.
Cardiovascular · 24d
Cleared Dec 20, 2013
GMK SHORT STEM
K133630 · JWH
Medacta International
Orthopedic · 24d
Cleared Dec 20, 2013
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
K133641 · IYO
Volcano Corporation
Radiology · 23d
Cleared Dec 20, 2013
CAPSTONE SPINAL SYSTEM
K133650 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 23d
Cleared Dec 19, 2013
COMPRESSOR NEBULIZER MODEL MCN-S600XX
K123030 · CAF
Dongguan Aidisy Machinery &...
Anesthesiology · 447d
Cleared Dec 19, 2013
SOFTVUE
K123209 · IYO
Delphinus Medical Technologies, Inc.
Radiology · 433d
Cleared Dec 19, 2013
YOUNG AGAIN
K124064 · OHS
Espansione Marketing S.P.A
General & Plastic Surgery · 353d
Cleared Dec 19, 2013
PHYSOFT AMS
K130579 · MQS
Physicians Software Systems, LLC
Gastroenterology & Urology · 289d
Cleared Dec 19, 2013
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
K130611 · KNT
Xeridiem Medical Devices
Gastroenterology & Urology · 287d
Cleared Dec 19, 2013
ELISIO-H HEMODIALYZER
K131381 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 219d
Cleared Dec 19, 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086 · NBW
ACON Laboratories, Inc.
Chemistry · 167d
Cleared Dec 19, 2013
VAPOR CERAMIC BRACKET
K132368 · NJM
Orthodontic Design and Production, Inc.
Dental · 142d
Cleared Dec 19, 2013
LP(A) CALIBRATORS, AND LP(A) CONTROLS
K132400 · JIT
Biokit, S.A.
Chemistry · 140d
Cleared Dec 19, 2013
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
K132623 · DQX
Medtronic
Cardiovascular · 119d
Cleared Dec 19, 2013
SMARTVEST AIRWAY CLEARANCE SYSTEM
K132794 · BYI
Electromed, Inc.
Anesthesiology · 104d
Cleared Dec 19, 2013
LINA POWERBLADE PLUS
K132837 · GEI
Lina Medical Aps
General & Plastic Surgery · 100d
Cleared Dec 19, 2013
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K132952 · HCG
MicroVention, Inc.
Neurology · 91d
Cleared Dec 19, 2013
SMARTLOG DIABETES MANAGEMENT SOFTWARE
K133346 · NBW
I-Sens, Inc.
Chemistry · 50d
Cleared Dec 19, 2013
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K133475 · KWQ
Nexxt Spine, LLC
Orthopedic · 37d
Cleared Dec 19, 2013
21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)
K133511 · LLZ
Jvckenwood Corporation
Radiology · 35d
Cleared Dec 19, 2013
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
K133561 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 29d
Cleared Dec 18, 2013
LUCO HYBRID OSA APPLIANCE
K130797 · LRK
Luco Hybrid Osa Appliance, Inc.
Dental · 271d