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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
48001–48024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2011
FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001
K101552 · CAF
Foshan Care Medical Technology Co., Ltd.
Anesthesiology · 283d
Cleared Mar 14, 2011
ECHO BLASTER
K102253 · IYO
Telemed
Radiology · 217d
Cleared Mar 14, 2011
TRANS1 AXIALIF PLUS
K102334 · KWQ
Trans1 Incorporated
Orthopedic · 209d
Cleared Mar 14, 2011
OSSPRAY SYLC CR
K103114 · EJR
Osspray, Ltd.
Dental · 144d
Cleared Mar 14, 2011
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM
K103156 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 139d
Cleared Mar 14, 2011
UBM PLUS
K103471 · IYN
Accutome, Inc.
Radiology · 110d
Cleared Mar 14, 2011
SILVER ANTIMICROBIAL WOUND GEL
K110458 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 25d
Cleared Mar 11, 2011
MERIT EMBOLECTOMY CATHETER MODEL ASAP100
K100569 · QEZ
Merit Medical Systems, Inc.
Cardiovascular · 375d
Cleared Mar 11, 2011
LINA XCISE MODEL MOR-1515
K101458 · HET
Lina Medical Aps
Obstetrics & Gynecology · 289d
Cleared Mar 11, 2011
BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS
K101607 · NHA
Biomet 3i, Inc.
Dental · 276d
Cleared Mar 11, 2011
BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS
K101608 · NHA
Biomet 3i, Inc.
Dental · 276d
Cleared Mar 11, 2011
ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM
K101913 · DZE
Anthogyr Sas
Dental · 246d
Cleared Mar 11, 2011
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102102 · JAK
VATECH Co., Ltd.
Radiology · 227d
Cleared Mar 11, 2011
NP15
K102515 · BZD
Weinmann Gerate Fur Medizin GmbH +...
Anesthesiology · 190d
Cleared Mar 11, 2011
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR,...
K102692 · FYA
Hangzhou Jincheng Medical Supplier...
General Hospital · 172d
Cleared Mar 11, 2011
DISCOVRED
K102821 · LFC
Phoenix Dental, Inc.
Dental · 164d
Cleared Mar 11, 2011
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL...
K102919 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 161d
Cleared Mar 11, 2011
FUKUDA DENSHI
K103134 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 137d
Cleared Mar 11, 2011
ISOGRAY TREATMENT PLANNING SYSTEM
K103146 · MUJ
Dosisoft SA
Radiology · 137d
Cleared Mar 11, 2011
AIDA DIAGNOSTIC ULTRASOUND SYSTEM
K103148 · IYO
Panasonic Healthcare Co., Ltd.
Radiology · 137d
Cleared Mar 11, 2011
CIV-OB (PLUS)
K103172 · HGM
Civnet Communication, Ltd.
Obstetrics & Gynecology · 134d
Cleared Mar 11, 2011
COUDE/ OR TIEMANN
K103371 · EZL
Degania Silicone , Ltd.
Gastroenterology & Urology · 114d
Cleared Mar 11, 2011
HEAD FIATION DEVICE (HFD 100)
K103493 · HBL
Imris, Inc.
Neurology · 102d
Cleared Mar 11, 2011
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD
K103712 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 81d