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
71233–71256 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 14, 2003
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
K032080 · HIL
Rostam , Ltd.
Obstetrics & Gynecology · 38d
Cleared Aug 14, 2003
XIVE DENTAL IMPLANT SYSTEM MULTIPLE
K032158 · DZE
Friadent GmbH
Dental · 30d
Cleared Aug 14, 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K032172 · LYZ
Synmertex Co, Ltd.
General Hospital · 29d
Cleared Aug 14, 2003
DISPOSABLE POWDERED VINYL EXAM GLOVES
K032190 · LYZ
Synmertex Co, Ltd.
General Hospital · 28d
Cleared Aug 14, 2003
XIVE TG DENTAL IMPLANT SYSTEM
K032284 · DZE
Friadent GmbH
Dental · 21d
Cleared Aug 14, 2003
ORTHOVIEW
K032401 · LLZ
Omsbar, Ltd.
Radiology · 10d
Cleared Aug 13, 2003
IVENT 201 PORTABLE VENTILATOR
K021981 · NOU
Versamed , Ltd.
Anesthesiology · 422d
Cleared Aug 13, 2003
PBN GUIDEWIRES
K031442 · DQX
Medical Device Technologies, Inc.
Cardiovascular · 99d