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
74305–74328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2002
AART SILICONE SHEETING
K022223 · MIB
Aesthetic and Reconstructive...
General & Plastic Surgery · 30d
Cleared Aug 08, 2002
MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
K022305 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 23d
Cleared Aug 08, 2002
ACTIBAND
K022404 · ILX
Paw, LLC
Physical Medicine · 16d
Cleared Aug 08, 2002
BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE,...
K022426 · JKA
Becton, Dickinson & CO
Chemistry · 14d
Cleared Aug 07, 2002
ALPHA DRIVE SYSTEM
K013396 · HAW
Alpha Omega , Ltd.
Neurology · 296d
Cleared Aug 07, 2002
ULTIMA SNORING MIKE, MODEL 0540
K020312 · MNR
Braebon Medical Corp.
Anesthesiology · 189d
Cleared Aug 07, 2002
800 SERIES EASYNEB NEBULIZER
K020357 · CAF
Nellcor Puritan Bennett, Inc.
Anesthesiology · 184d
Cleared Aug 07, 2002
K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
K021492 · NUC
Personal Products Co., Div. of Mcneil...
Obstetrics & Gynecology · 90d
Cleared Aug 07, 2002
OPUSDUO EC DENTAL LASER SYSTEM
K021508 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 90d
Cleared Aug 07, 2002
MDA D-DIMER
K021877 · GHH
bioMerieux, Inc.
Hematology · 61d
Cleared Aug 07, 2002
COAMATIC AT-400
K022195 · JBQ
Instrumentation Laboratory CO
Hematology · 33d
Cleared Aug 06, 2002
PRISMA SYSTEM
K010805 · KDI
Gambro Renal Products
Gastroenterology & Urology · 508d
Cleared Aug 06, 2002
LODOX, MODEL BASELINE
K013999 · JAK
Lodox Systems (Pty), Ltd.
Radiology · 245d
Cleared Aug 06, 2002
EASYTEM EAR THERMOMETER, MODEL BT-020
K020520 · FLL
Metatech Co., Ltd.
General Hospital · 168d
Cleared Aug 06, 2002
ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400
K020897 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 140d
Cleared Aug 06, 2002
HMS-DHR-3 NEUROMUSCULAR STIMULATOR
K021472 · IPF
Home Medical Services
Physical Medicine · 90d
Cleared Aug 06, 2002
BRESAGEN CATHETER, MODEL CS-3000
K021481 · HCA
Bresagen, Inc.
Neurology · 90d
Cleared Aug 06, 2002
HMS-DHR-3 NEUROMUSCULAR STIMULATOR
K021496 · GZJ
Home Medical Services
Neurology · 89d
Cleared Aug 06, 2002
CYTOFLEX MESH
K021511 · JEY
Unicare Biomedical, Inc.
Dental · 89d
Cleared Aug 06, 2002
ADC DENTAL
K021542 · MUH
Agfa Corp.
Radiology · 88d
Cleared Aug 06, 2002
PERF (OMMAYA STYLE) RESERVOIRS
K021644 · JXG
Phoenix Biomedical Corp.
Neurology · 78d
Cleared Aug 06, 2002
CRYOBAG, MODEL CB
K021702 · LPZ
Origen Biomedical, Inc.
General Hospital · 75d
Cleared Aug 06, 2002
E-CARE INFARED EAR THERMOMETER, MODEL LCT-200
K021753 · FLL
E-Care Technology Corporation
General Hospital · 69d
Cleared Aug 06, 2002
MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
K021974 · MRZ
Minimed, Inc.
General Hospital · 50d