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
63697–63720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2006
MODIFICATION TO S4 SPINAL SYSTEM
K060152 · MNI
Aesculap, Inc.
Orthopedic · 14d
Cleared Feb 02, 2006
GRANTALDER RHAPSODY ACCESS PORT AND CATHETER
K043178 · LJT
Grantadler Corportation
General Hospital · 443d
Cleared Feb 02, 2006
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
K052192 · HIB
Femspec LLC
Obstetrics & Gynecology · 175d
Cleared Feb 02, 2006
LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM
K052446 · DRT
Hoana Medical, Inc.
Cardiovascular · 148d
Cleared Feb 02, 2006
AQUADEX FLEXFLOW SYSTEM
K060008 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 01, 2006
TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)
K052608 · DRG
Bl Healthcare, Inc.
Cardiovascular · 132d
Cleared Feb 01, 2006
KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES
K052731 · MQX
Daxin LI
General Hospital · 125d
Cleared Feb 01, 2006
RADIANCY FACIAL SKINCARE DEVICE
K052991 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 99d
Cleared Feb 01, 2006
INTERFACE
K053103 · KLE
Apex Dental Materials, Inc.
Dental · 89d
Cleared Feb 01, 2006
PREFORMANCE POSTS
K053170 · NHA
Implant Innovations, Inc.
Dental · 79d
Cleared Feb 01, 2006
SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS
K053178 · ELC
Hu-Friedy Mfg. Co., Inc.
Dental · 79d
Cleared Feb 01, 2006
LUCAS
K053403 · DRM
Jolife AB
Cardiovascular · 57d
Cleared Feb 01, 2006
YAG MIR FAMILY LASER
K053421 · GEX
Cynosure, Inc.
General & Plastic Surgery · 55d
Cleared Feb 01, 2006
BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
K053443 · KGO
Regent Medical Americas, LLC
General Hospital · 54d
Cleared Jan 31, 2006
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
K050952 · KDI
Minntech Corp.
Gastroenterology & Urology · 291d
Cleared Jan 31, 2006
GALIX ECG PROFESSIONAL STATION
K051163 · DPS
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 271d
Cleared Jan 31, 2006
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
K051648 · CGS
Arkray, Inc.
Chemistry · 224d
Cleared Jan 31, 2006
EMG HANDLE NEBULIZER NB02 SERIES
K052438 · CAF
Emg Technology Co., Ltd.
Anesthesiology · 147d
Cleared Jan 31, 2006
NAVIGATOR ENDOSCOPY SYSTEM
K052930 · FDF
Neoguide Systems, Inc.
Gastroenterology & Urology · 104d
Cleared Jan 31, 2006
TECHDEVICE GUIDEWIRE
K053028 · OCY
Techdevice Corporation
Gastroenterology & Urology · 96d
Cleared Jan 31, 2006
BIOSIGN
K053112 · MWI
Oxford Biosignals Limited
Cardiovascular · 88d
Cleared Jan 31, 2006
MINI-WRIGHT DIGITAL, MODEL 3120001
K053156 · BZH
Clement Clarke Intl., Ltd.
Anesthesiology · 78d
Cleared Jan 31, 2006
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
K053177 · LZG
Medtronic Minimed
General Hospital · 78d
Cleared Jan 31, 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND...
K053226 · FRN
Zimmer, Inc.
General Hospital · 75d