Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
71833–71856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2003
VAXCEL PORT, MODELS 45-336 AND 45-338
K032375 · LJT
Boston Scientific Corp
General Hospital · 18d
Cleared Aug 18, 2003
STERRAD 200 STERILIZER
K030429 · MLR
Advanced Sterilization Products
General Hospital · 189d
Cleared Aug 18, 2003
JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET
K030479 · FOZ
Jms North America Corp.
General Hospital · 186d
Cleared Aug 18, 2003
FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT
K030730 · CDZ
Diagnostics Biochem Canada, Inc.
Chemistry · 161d
Cleared Aug 18, 2003
BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
K031742 · DQA
Bci, Inc.
Anesthesiology · 75d
Cleared Aug 18, 2003
PEM 2400 PET SCANNER
K032063 · KPS
Pem Technologies
Radiology · 46d
Cleared Aug 18, 2003
BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE...
K032131 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Aug 18, 2003
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K032287 · JIX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Aug 15, 2003
VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
K023140 · BSO
Epimed International, Inc.
Anesthesiology · 329d
Cleared Aug 15, 2003
VPAP III
K030843 · BZD
Resmed, Ltd.
Anesthesiology · 151d
Cleared Aug 15, 2003
POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE...
K031157 · LZA
Qingdao Bestex Rubber & Plastic...
General Hospital · 126d
Cleared Aug 15, 2003
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
K031958 · FLL
Microlife Intellectual Property GmbH
General Hospital · 51d
Cleared Aug 15, 2003
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
K032168 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 30d
Cleared Aug 15, 2003
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
K032369 · MHX
Ge Medical Systems Information...
Cardiovascular · 14d
Cleared Aug 15, 2003
NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007
K032372 · JAQ
Nucletron Corporation
Radiology · 14d
Cleared Aug 14, 2003
AUSAM TOTAL ALBUMIN ASSAY
K013643 · JIQ
Ausam Biotecthnologies, Inc.
Chemistry · 647d
Cleared Aug 14, 2003
MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K021560 · FIP
Ameriwater
Gastroenterology & Urology · 458d
Cleared Aug 14, 2003
VIANOX DELIVERY SYSTEM, MODEL I
K023014 · MRP
Pulmonox Medical, Inc.
Anesthesiology · 338d
Cleared Aug 14, 2003
MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM
K031674 · DZE
Friadent GmbH
Dental · 76d
Cleared Aug 14, 2003
STATCO2METER, MODEL 10-55372
K031814 · CCK
Mercury Medical
Anesthesiology · 63d
Cleared Aug 14, 2003
DVNET MDV-PACS
K031816 · LLZ
Dvnet International Technology Co., Ltd.
Radiology · 63d
Cleared Aug 14, 2003
PHILIPS FRESCO RELEASE 1
K031836 · LLZ
Philips Medical Systems North America...
Radiology · 62d
Cleared Aug 14, 2003
MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC
K031866 · JAI
Med-Tec,Inc.
Radiology · 59d
Cleared Aug 14, 2003
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
K031957 · LPN
Ciba Vision Corporation
Ophthalmic · 50d