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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
75433–75456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 06, 2002
F 900
K022054 · HKY
C.S.O. S.R.L.
Ophthalmic · 43d
Cleared Aug 06, 2002
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
K022065 · JEC
Sintea Biotech, Inc.
Orthopedic · 42d
Cleared Aug 06, 2002
ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
K022209 · FPA
Alaris Medical Systems, Inc.
General Hospital · 29d
Cleared Aug 06, 2002
MOBILE MILLENNIUM MG SYSTEM
K022240 · KPS
Ge Medical Systems, Inc.
Radiology · 26d
Cleared Aug 06, 2002
STRYKER L3 HYDROLERT
K022248 · FLN
Stryker Endoscopy
General Hospital · 25d
Cleared Aug 06, 2002
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
K022281 · DTN
Polystan A/S
Cardiovascular · 22d
Cleared Aug 06, 2002
BLACKSTONE SPINAL FIXATION SYSTEM SPACER
K022399 · KWQ
Blackstone Medical, Inc.
Orthopedic · 14d