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
74137–74160 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2002
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL
K020936 · MSD
Medcomp
Gastroenterology & Urology · 203d
Cleared Oct 11, 2002
NEICH NM ADVANCE CATHETER SHEATH INTRODUCER
K020964 · DYB
Neich Medical(Shenzhen)Company, Ltd.
Cardiovascular · 200d
Cleared Oct 11, 2002
HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300
K021087 · DQD
Erecords Limited
Cardiovascular · 191d
Cleared Oct 11, 2002
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL...
K021446 · BTM
Oemedic International, Inc.
Anesthesiology · 158d
Cleared Oct 11, 2002
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS...
K021752 · HQD
Lucid Korea Co., Ltd.
Ophthalmic · 136d
Cleared Oct 11, 2002
COMFORT DREAMRIDER SCOOTER, LY-EW402
K021910 · INI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 123d
Cleared Oct 11, 2002
TGDC-01 PRA
K021937 · HKX
Truevision Instruments
Ophthalmic · 121d
Cleared Oct 11, 2002
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM)...
K022117 · DRC
Merit Medical Systems, Inc.
Cardiovascular · 102d
Cleared Oct 11, 2002
STOCKERT CORONARY PERFUSION CANNULAE
K022280 · DWF
Stockert Instrumente GmbH
Cardiovascular · 88d
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