510(k) Submissions Written by Kamm & Associates: fda-consultant.com
|
Company Name |
Device Name |
510(k) Number |
|
Grass-Astromed |
EEG Software |
K963669 |
|
Yoshida
( |
Panoramic Dental X-Ray |
K965072 |
|
Snap Laboratories |
Apnea Monitor |
K971184 |
|
Amplifon ( |
Evoked Potential Monitor |
K971740 |
|
Amplifon ( |
Audiometer |
K971747 |
|
|
Periodontal Depth Probe, Electronic |
K972642 |
|
Amplifon ( |
Audiometer |
K972862 |
|
Amplifon ( |
Evoked Potential Monitor |
K972959 |
|
Ortivus ( |
ECG Monitor, Ambulance |
K973318 |
|
Amplifon ( |
Auditory Impedance Tester |
K974235 |
|
Lorac |
Acupuncture Needles |
K974616 |
|
Sam Technologies |
EEG/MRI Software |
K980477 |
|
NidaCon International ( |
Sperm Separation Medium |
K980814 |
|
Amplifon ( |
Audiometers |
K983712 |
|
Amplifon ( |
Audiometers |
K983915 |
|
Snap Laboratories |
Ventilatory Effort Recorder |
K984169 |
|
NidaCon International ( |
Sperm Separation Medium |
K984172 |
|
ElectraMed |
Measuring Ergometer |
K990813 |
|
Intercontinental New Technologies |
Breathing Exercise Device |
K992256 |
|
Ljungberg-Kogel ( |
Bloodbank Scale/Mixer |
|
|
Snap Laboratories |
Ventilatory Effort Recorder |
|
|
Amplifon ( |
Auditory Impedance Meter |
|
|
IODP (France) |
3D
Ultrasound Software |
|
|
Sewoon Medical Device ( |
Silicone Foley Catheters |
|
|
E.S.W.L. Products, Inc |
Extracorporeal Lithotripter |
|
|
CANČ S.r.l. ( |
Ambulatory Infusion Pump |
|
|
CANČ S.r.l. ( |
Insulin Infusion Pump |
|
|
CANČ S.r.l. ( |
Ambulatory Infusion Pump for Pain Management |
|
|
CANČ S.r.l. ( |
Ambulatory Infusion Pump |
|
|
CANČ S.r.l. ( |
Ambulatory Infusion Pump |
|
|
|
MRI Coil |
|
|
PadPro LLC |
Disposable Defibrillator Electrode |
K014209 (Special) |
|
Vector Research and Development |
High-speed Dental Handpieces |
|
|
Capsule Technologie (France) |
Modification to Data Acquisition Software |
K020197 (Special) |
|
PadPro LLC |
Disposable Defibrillator Electrode |
|
|
PadPro LLC |
Disposable Defibrillator Electrode |
K020288 (Special) |
|
|
Breast Biopsy Intervention Aid for MRI |
|
|
Sedecal
( |
Portable X-Ray System |
|
|
Evans Medical, Inc |
Winged Subcutaneous Infusion Set |
|
|
PadPro LLC |
Disposable Defibrillator Electrode |
|
|
Toei
Electric Company Limited ( |
Dental Root Apex Locator |
K022020 (Special) |
|
|
Sperm Re-suspension Medium for Assisted Reproductive Technology |
|
|
Health Care Manufacturing, Inc. |
General Purpose Radiographic X-Ray System |
|
|
Health Care Manufacturing, Inc. |
Chiropractic X-Ray System |
|
|
|
Sperm Cryopreservative for Assisted Reproductive Technology |
|
|
Meridian
Co. Ltd. ( |
Photoelectric Plethysmograph |
|
|
Jeil Medical Corporation ( |
LeForte System Bone Plates |
|
|
Jeil Medical Corporation ( |
LeForte System Bone Screws |
|
|
BioSpace Corp. Ltd. ( |
Body Composition Analyzer |
|
|
Analyticon Biotechnologies AG ( |
Urine Test Strips |
|
|
Ralco
S.r.l. ( |
X-Ray Collimator |
|
|
SEZ Corporation ( |
Safety Syringe |
|
|
Ethox, Inc. |
Blood Pressure Cuff Cover |
|
|
GS
Technology Co., Ltd. ( |
Electronic Stethoscope |
|
|
Nihon
Seimitsu Sokki Co., Ltd. ( |
Combination Blood Pressure Meter/Body Composition Analyzer |
|
|
Carematix, Inc |
Home Wellness System |
|
|
KaVo America Corporation |
Dental Polishing Agent |
K031868 (Special) |
|
Med
Systems Inc |
Chest
Percussor |
|
|
Amplaid ( |
Screening Auditory Impedance Tester |
K031978 (Special) |
|
KaVo America Corporation |
Zirconium Oxide Dental Device |
K032081 (Special) |
|
Capsule Technologie (France) |
Data Acquisition Software |
K032142 (Special) |
|
Remco Italia S.p.A. ( |
Electrocardiograph with Analysis |
K032200 (Abbreviated) |
|
OMI
Manufacturing Pty Ltd ( |
Safety Scalpel |
|
|
Livingston
Products, Inc. |
Breast
Compression Paddle |
|
|
The Buzz Group LLC |
Digital Blood Pressure Monitor |
|
|
KaVo America Corporation |
Zirconium Oxide Dental Device |
K033221 (Special) |
|
Medlink Imaging |
Digital X-Ray System |
K033599 (Abbreviated) |
|
Jeil Medical Corporation ( |
Titanium Screw Implants, Orthodontic |
|
|
Meridian
Co. ( |
Laser for pain therapy |
|
|
Mikasa ( |
Portable X-Ray |
K040046 (Special) |
|
Nissei ( |
Digital Blood Pressure Monitor |
K040309 |
|
Canamet ( |
Ambulatory Blood Pressure Monitor |
|
|
KHN Solutions LLC |
Digital Breath Alcohol Test System |
K041334 |
|
CANČ S.r.l. ( |
Ambulatory Infusion Pump |
K041414 (Special) |
|
Tympany |
Combination -Pure tone and speech audiometer, impedance audiometer, and distortion product otoacoustic emissions analyzer |
|
|
CANČ S.r.l. ( |
Ambulatory Infusion Pump |
K042085 (Special) |
|
Sedecal
( |
Digital X-Ray System |
K042361 (Special) |
|
Vatech |
Digital Dental X-Ray Sensor |
|
|
KaVo Dental Corporation |
Subgingival Dental Calculus Detector (Laser) |
|
|
EDDA Technology, Inc. |
PACS System |
K042408 |
|
BioSpace Corp. Ltd. ( |
Body Composition Analyzer |
|
|
KaVo America Corporation |
Dental Handpiece- Airbrush |
K042872 (Special) |
|
Sedecal
( |
Digital X-Ray System |
K042876 (Special) |
|
Q3 Innovations, LLC |
Digital Breath Alcohol Test System |
|
|
Medexel ( |
Safety Syringe |
|
|
Panoramic Corp |
Panoramic Dental X-Ray |
K043557 |
|
FIM Medical |
Spirometer Filter |
|
|
Jeil Medical Corporation ( |
Dental Bone Fixation System |
|
|
KaVo Dental Corporation |
Dental Video System |
|
|
CRS Medical |
Endoluminal Brush |
|
|
VitalCare Group, Inc. |
IV Administration Set |
|
|
eemagine Medical Imaging Solutions GmbH ( |
EEG and Evoked Potential Hardware and Software |
|
|
KaVo Dental Corporation |
Laser Caries Detector |
|
|
Heeyoung Co. Ltd ( |
LCD Monitors for Cardiology |
|
|
Connectables LLC |
Breath Alcohol Tester |
|
|
Shanghai
Fimet ( |
Dental Chair with Operative Unit |
|
|
|
Diagnostic X-Ray System |
|
|
Biospace
( |
Body Composition Monitors |
|
|
Mikasa ( |
Portable X-Ray |
K052721 (Special) |
|
Cardiocom LLC |
Non-invasive automated blood pressure meter. |
|
|
Waldmann Lighting |
Surgical Lamp |
|
|
Scorpion (France) |
Ultrasonic Scaling Inserts |
|
|
Diagnostic Devices Inc. |
Blood Glucose Meter |
|
|
KaVo Dental Corporation |
Subgingival Dental Calculus Detector (Laser) |
K060080 (Special) |
|
KaVo Dental Corporation |
Dental Imaging System |
|
|
Implant Logic Systems |
Dental Implant Planning Software |
|
|
B&L Biotech Co. Ltd ( |
Gutta Percha Gun |
|
|
MBL International Corporation ( |
ELISA Kit |
|
|
Diagnostic Devices Inc. |
Blood Glucose Meter |
|
|
Mikasa ( |
Podiatric X-Ray |
K060566 (Special) |
|
OMI
( |
Safety Syringe |
|
|
Medical Devices/Padpro |
Defibrillator Tester |
|
|
Sedecal
( |
Diagnostic X-Ray System |
K062335 (Special) |
|
RMI, Incl. |
Breath
Alcohol Detector |
|
|
Pishon High Tech Co., Ltd ( |
Electronic Stethoscope |
|
|
BioSpace Corp. Ltd. ( |
Body Composition Analyzer |
|
|
Virtual Imaging |
Mobile X-Ray System |
|
|
GE Medical |
Digital X-Ray System |
|
|
Amann Girrbach ( |
Dental Material |
|
|
Yoshida
( |
Dental CT |
|
|
KaVo Dental Corporation |
Dental Material |
|
|
Daejin ( |
Insulin Syringe |
|
|
Daejin ( |
Insulin Pen Needle |
|
|
Resource Management International LLC |
Breath Alcohol Detector |
|
|
Vidar Systems Corp |
Digital X-Ray System |
K071193 (Special) |
|
Synvasive Technology Inc |
Knee Implant Adjustment Tool |
|
|
Eemagine Medical Imaging Solutions ( |
EEG
Software |
|
|
Virtual Imaging |
Digital Fluoroscopic Camera |
|
|
CDL Technologies Inc |
Dental Material |
|
|
Feel Tech ( |
Insulin Syringe |
|
KHN Solutions
|
Breath Alcohol Detector |
|
MBL International Corp (
|
IVD Elisa Kits |
|
MI Tech Co. Ltd (
|
Esophageal Stent |
|
|
Airistar |
Medical Air Purifier |
|
|
CRS Medical |
Fibrin Analysis Catheter Test
System |
|
|
Dooyang Systems ( |
LCD Monitors |
|
|
Takara Belmont ( |
Cone |
|
|
Almana Medical ( |
Diagnostic X-Ray Systems |
|
|
Ralco ( |
X-Ray Collimator, Automatic |
|
|
Kavo ( |
Surgical Laser |
|
|
IMIX ADR ( |
Digital X-Ray System |
|
|
EBI, Inc. ( |
Endosseous Implant |
|
|
AIIA Communication Inc. ( |
Body Composition Analyzer |
|
|
Fujifilm Medical Systems |
Digital X-Ray System |
|
|
FIM Medical ( |
CO Tester |
|
|
The Ashley Collection |
Key Ring Alcohol Tester |
|
|
Meinntech CO., LTD ( |
Intravascular Administration Set |
|
|
Medicatech
|
Digital X-Ray Systems |
|
|
MAC
Medical |
Irrigation
Solution Warmer |
|
|
Almana
Medical Imaging ( |
Digital
X-Ray System |
|
|
Almana
Medical Imaging ( |
Fluoroscopy
System |
|
|
Q3
Innovations |
Breath
Alcohol Detector |
|
|
Feel
Tech ( |
Insulin
Pen Needle |
|
|
Elekta
Neuromag OY ( |
EEG
with Filter |
|
|
Amplivox ( |
Auditory
Impedance Tester |
|
|
Almana Medical Imaging ( |
Diagnostic
X-Ray Systems |
|
|
dxRAD ( |
Digital
X-Ray Systems |
|
|
Viztek |
Digital
X-Ray Systems |
|
|
Minxray |
Digital
X-Ray Systems |
|
|
Medicatech |
Digital
X-Ray Systems |
|
|
Ralco
s.r.l. ( |
X-Ray
Collimator, Automatic |
|
|
Suinsa ( |
Diagnostic
X-Ray Systems |
|
|
Virtual
Imaging |
Fluoroscopic
C-Arm |
|
|
KHN Solutions |
Breath
Alcohol Tester |
|
|
KHN Solutions |
Breath
Alcohol Tester |
|
|
Masters
Healthcare |
Insulin
Syringes |
|
|
Ljungberg-Kogel ( |
Wireless
Option for Bloodbank Scale/Mixer |
|
|
Sedecal
( |
Modified
Mobile X-Ray (Film and Digital) |
|
|
Sedecal
( |
Digital
X-Ray Systems |
|
|
Sedecal
( |
Digital
X-Ray Systems |
|
|
Ralco
s.r.l. ( |
X-Ray
Collimator, Automatic |
Revised 26 August 2009