FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73633–73656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2002
ENCIRCLE LOCALIZATION DEVICE
K022286 · KNW
Vivant Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Oct 11, 2002
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD
K022336 · LYZ
Tangshan Zhonghong Pulin Group Co., Ltd.
General Hospital · 85d
Cleared Oct 11, 2002
COMFORT WINDJOY SCOOTER, MODEL LY-EW302
K022369 · INI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 81d
Cleared Oct 11, 2002
HITACHI ALTAIRE
K022390 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 80d
Cleared Oct 11, 2002
REUSABLE BRONCHIAL BIOPSY FORCEPS
K022398 · BWH
Ballard Medical Products
Ear, Nose, Throat · 80d
Cleared Oct 11, 2002
BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST
K022415 · FMI
Waismed, Ltd.
General Hospital · 79d
Cleared Oct 11, 2002
PULPDENT SEMI-GEL ETCH
K022492 · EBF
Pulpdent Corporation
Dental · 74d
Cleared Oct 11, 2002
EMS 400
K022493 · IPF
Body Clock Health Care, Ltd.
Physical Medicine · 74d
Cleared Oct 11, 2002
GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
K022545 · NBW
Hypoguard USA, Inc.
Chemistry · 71d
Cleared Oct 11, 2002
VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION
K022562 · DZE
Nobel Biocare AB
Dental · 70d
Cleared Oct 11, 2002
KIMAX QMA
K022585 · LLZ
Medical Metrics, Inc.
Radiology · 67d
Cleared Oct 11, 2002
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND...
K022620 · FKA
Spire Biomedical, Inc.
Gastroenterology & Urology · 65d
Cleared Oct 11, 2002
VOXELPLUS PACS
K022692 · LLZ
Mevisys Co., Ltd.
Radiology · 59d
Cleared Oct 11, 2002
SMARTPACS
K022710 · LLZ
Taiwan Electronic Data Processing...
Radiology · 58d
Cleared Oct 11, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
K022716 · HNO
Med-Logics, Inc.
Ophthalmic · 57d
Cleared Oct 11, 2002
AUDIOTRAVELLER, MODEL AA222
K022728 · ETY
Interacoustics A/S, Assens
Ear, Nose, Throat · 56d
Cleared Oct 11, 2002
SPIFE CK KIT, MODEL 3332, 3333
K022757 · JHY
Helena Laboratories
Chemistry · 52d
Cleared Oct 11, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K022765 · LZA
Allegiance Healthcare Corp.
General Hospital · 52d
Cleared Oct 11, 2002
E-SPEED EBT SCANNER SYSTEM
K022794 · JAK
Ge Imatron
Radiology · 49d
Cleared Oct 11, 2002
COBRASCAN CR-1 FILMLESS
K022810 · LMA
Radiographic Digital Imaging, Inc.
Radiology · 49d
Cleared Oct 11, 2002
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K022897 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 38d
Cleared Oct 11, 2002
IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
K022940 · LLZ
Intelligent Images Srl
Radiology · 37d
Cleared Oct 11, 2002
ACUITY RADIATION THERAPY SIMULATOR
K023052 · KPQ
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Oct 11, 2002
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
K023061 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 25d