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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74041–74064 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2002
RANDOX APOLIPOPROTEIN CALIBRATOR
K023158 · JIX
Randox Laboratories, Ltd.
Chemistry · 31d
Cleared Oct 24, 2002
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA...
K023182 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 30d
Cleared Oct 24, 2002
E.CAM COMPUTER / E.SOFT WORKSTATION
K023190 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Oct 24, 2002
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
K023194 · CGA
Lifescan, Inc.
Chemistry · 29d
Cleared Oct 24, 2002
CEDIA CYCLOSPORINE PLUS ASSAY
K023208 · MKW
Microgenics Corp.
Chemistry · 29d
Cleared Oct 24, 2002
MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER
K023223 · DQY
Lumend, Inc.
Cardiovascular · 27d
Cleared Oct 24, 2002
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
K023475 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 8d
Cleared Oct 23, 2002
CMA CEREBRAL TISSUE MONITORING SYSTEM
K020285 · GWM
Cma Microdialysis AB
Neurology · 268d
Cleared Oct 23, 2002
MICROSCAN SYNERGIES PLUS
K023202 · JWY
Dade Microscan, Inc.
Microbiology · 28d
Cleared Oct 23, 2002
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332 · JAK
GE Medical Systems
Radiology · 16d
Cleared Oct 22, 2002
SMITHWICK CAROTID SHUNT
K021608 · DXC
Implantable Devices
Cardiovascular · 159d
Cleared Oct 22, 2002
MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
K022420 · HCG
Micrus Corp.
Neurology · 90d
Cleared Oct 22, 2002
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED...
K022450 · DTZ
Dideco S.P.A.
Cardiovascular · 88d
Cleared Oct 22, 2002
MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100
K022535 · EFB
Microtech
Dental · 83d
Cleared Oct 22, 2002
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
K022582 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Oct 22, 2002
HCMI X-RAY
K022667 · KPR
Health Care Mfg., Inc.
Radiology · 71d
Cleared Oct 22, 2002
HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
K022737 · KPR
Health Care Mfg., Inc.
Radiology · 64d
Cleared Oct 22, 2002
CEDARA I-SOFTVIEW
K022881 · LLZ
Cedara Software Corp.
Radiology · 53d
Cleared Oct 22, 2002
BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200
K023055 · DXN
Vsm Medtech , Ltd.
Cardiovascular · 39d
Cleared Oct 22, 2002
USG 2000SA
K023227 · HHJ
Ultraguide , Ltd.
Radiology · 25d
Cleared Oct 22, 2002
DRYSTAR 5500
K023287 · LMC
Agfa Corp.
Radiology · 20d
Cleared Oct 21, 2002
DIASOL-ADDITIVES
K020231 · KPO
Diasol, Inc.
Gastroenterology & Urology · 271d
Cleared Oct 21, 2002
56 SERIES JET NEBULIZER
K021443 · CAF
Project Marketing
Anesthesiology · 168d
Cleared Oct 21, 2002
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
K022391 · KDN
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 90d