510(k) Submissions Written by Kamm
& Associates: fda-consultant.com
(Over 200 successful clearances)
|
Company Name |
Device Name |
510(k) Number |
|
Grass-Astromed |
EEG
Software |
K963669 |
|
Yoshida
(Japan) |
Panoramic
Dental X-Ray |
K965072 |
|
Snap
Laboratories |
Apnea
Monitor |
K971184 |
|
Amplifon (Italy) |
Evoked
Potential Monitor |
K971740 |
|
Amplifon (Italy) |
Audiometer |
K971747 |
|
|
Periodontal
Depth Probe, Electronic |
K972642 |
|
Amplifon (Italy) |
Audiometer |
K972862 |
|
Amplifon (Italy) |
Evoked
Potential Monitor |
K972959 |
|
Ortivus (Sweden) |
ECG
Monitor, Ambulance |
K973318 |
|
Amplifon (Italy) |
Auditory
Impedance Tester |
K974235 |
|
Lorac |
Acupuncture
Needles |
K974616 |
|
Sam
Technologies |
EEG/MRI
Software |
K980477 |
|
NidaCon International
(Sweden) |
Sperm
Separation Medium |
K980814 |
|
Amplifon (Italy) |
Audiometers |
K983712 |
|
Amplifon (Italy) |
Audiometers |
K983915 |
|
Snap
Laboratories |
Ventilatory Effort
Recorder |
K984169 |
|
NidaCon International
(Sweden) |
Sperm
Separation Medium |
K984172 |
|
ElectraMed |
Measuring
Ergometer |
K990813 |
|
Intercontinental
New Technologies |
Breathing
Exercise Device |
K992256 |
|
Ljungberg-Kogel (Sweden) |
Bloodbank Scale/Mixer |
BK990013 |
|
Snap
Laboratories |
Ventilatory Effort
Recorder |
K992322 |
|
Amplifon (Italy) |
Auditory
Impedance Meter |
K992370 |
|
IODP
(France) |
3D
Ultrasound Software |
K011095 |
|
Sewoon Medical Device
(Korea) |
Silicone
Foley Catheters |
K013276 |
|
E.S.W.L.
Products, Inc |
Extracorporeal
Lithotripter |
K013471 |
|
CANČ
S.r.l. (Italy) |
Ambulatory
Infusion Pump |
K013776 |
|
CANČ
S.r.l. (Italy) |
Insulin
Infusion Pump |
K013807 |
|
CANČ
S.r.l. (Italy) |
Ambulatory
Infusion Pump for Pain Management |
K013822 |
|
CANČ
S.r.l. (Italy) |
Ambulatory
Infusion Pump |
K013840 |
|
CANČ
S.r.l. (Italy) |
Ambulatory
Infusion Pump |
K013855 |
|
|
MRI
Coil |
K013985 |
|
PadPro LLC |
Disposable
Defibrillator Electrode |
K014209 (Special) |
|
Vector
Research and Development |
High-speed
Dental Handpieces |
K020113 |
|
Capsule
Technologie (France) |
Modification
to Data Acquisition Software |
K020197 (Special) |
|
PadPro LLC |
Disposable
Defibrillator Electrode |
K020203 |
|
PadPro LLC |
Disposable
Defibrillator Electrode |
K020288 (Special) |
|
|
Breast
Biopsy Intervention Aid for MRI |
K020289 |
|
Sedecal
(Spain) |
Portable
X-Ray System |
K020436 |
|
Evans
Medical, Inc |
Winged
Subcutaneous Infusion Set |
K020530 |
|
PadPro LLC |
Disposable
Defibrillator Electrode |
K020743 |
|
Toei
Electric Company Limited (Japan) |
Dental
Root Apex Locator |
K022020 (Special) |
|
|
Sperm
Re-suspension Medium for Assisted Reproductive Technology |
K022443 |
|
Health
Care Manufacturing, Inc. |
General
Purpose Radiographic X-Ray System |
K022667 |
|
Health
Care Manufacturing, Inc. |
Chiropractic
X-Ray System |
K022737 |
|
|
Sperm
Cryopreservative for Assisted Reproductive
Technology |
K023206 |
|
Meridian
Co. Ltd. (Korea) |
Photoelectric
Plethysmograph |
K023238 |
|
Jeil Medical
Corporation (Korea) |
LeForte System Bone Plates |
K023360 |
|
Jeil Medical
Corporation (Korea) |
LeForte System Bone Screws |
K023365 |
|
BioSpace
Corp. Ltd. (Korea) |
Body
Composition Analyzer |
K023478 |
|
Analyticon Biotechnologies AG
(Germany) |
Urine
Test Strips |
K023885 |
|
Ralco
S.r.l. (Italy) |
X-Ray
Collimator |
K030487 |
|
SEZ
Corporation (Korea) |
Safety
Syringe |
K031163 |
|
Ethox, Inc. |
Blood
Pressure Cuff Cover |
K031195 |
|
GS
Technology Co., Ltd. (Korea) |
Electronic
Stethoscope |
K031446 |
|
Nihon
Seimitsu Sokki Co., Ltd. (Japan) |
Combination
Blood Pressure Meter/Body Composition Analyzer |
K031582 |
|
Carematix, Inc |
Home
Wellness System |
K031840 |
|
KaVo America
Corporation |
Dental
Polishing Agent |
K031868 (Special) |
|
Med
Systems Inc |
Chest
Percussor |
K031876 |
|
Amplaid (Italy) |
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. (Italy) |
Electrocardiograph
with Analysis |
K032200 (Abbreviated) |
|
OMI
Manufacturing Pty Ltd (Australia) |
Safety
Scalpel |
K032242 |
|
Livingston
Products, Inc. |
Breast
Compression Paddle |
K033202 |
|
The
Buzz Group LLC |
Digital
Blood Pressure Monitor |
K033216 |
|
KaVo America
Corporation |
Zirconium
Oxide Dental Device |
K033221 (Special) |
|
Medlink
Imaging |
Digital
X-Ray System |
K033599 (Abbreviated) |
|
Jeil Medical
Corporation (Korea) |
Titanium
Screw Implants, Orthodontic |
K033767 |
|
Meridian
Co. (Korea) |
Laser
for pain therapy |
K034009 |
|
Mikasa (Japan)/MinXray |
Portable
X-Ray |
K040046 (Special) |
|
Nissei (Japan) |
Digital
Blood Pressure Monitor |
K040309 |
|
KHN
Solutions LLC |
Digital
Breath Alcohol Test System |
K041334 |
|
Tympany |
Combination
-Pure tone and speech audiometer, impedance audiometer, and distortion
product otoacoustic emissions analyzer |
K041853 |
|
CANČ
S.r.l. (Italy) |
Ambulatory
Infusion Pump |
K042085 (Special) |
|
Sedecal
(Spain) |
Digital
X-Ray System |
K042361 (Special) |
|
Vatech |
Digital
Dental X-Ray Sensor |
K042372 |
|
KaVo Dental Corporation |
Subgingival Dental Calculus
Detector (Laser) |
K042394 |
|
EDDA
Technology, Inc. |
PACS
System |
K042408 |
|
BioSpace
Corp. Ltd. (Korea) |
Body
Composition Analyzer |
K042528 |
|
KaVo America
Corporation |
Dental
Handpiece- Airbrush |
K042872 (Special) |
|
Sedecal
(Spain) |
Digital
X-Ray System |
K042876 (Special) |
|
Q3
Innovations, LLC |
Digital
Breath Alcohol Test System |
K043188 |
|
Medexel (Korea) |
Safety
Syringe |
K043419 |
|
Panoramic
Corp |
Panoramic
Dental X-Ray |
K043557 |
|
FIM
Medical |
Spirometer Filter |
K050424 |
|
Jeil Medical
Corporation (Korea) |
Dental
Bone Fixation System |
K050669 |
|
KaVo Dental Corporation |
Dental
Video System |
K050744 |
|
CRS
Medical |
Endoluminal Brush |
K050889 |
|
VitalCare Group, Inc. |
IV
Administration Set |
K050906 |
|
eemagine Medical Imaging
Solutions GmbH (Germany) |
EEG
and Evoked Potential Hardware and Software |
K051825 |
|
KaVo Dental Corporation |
Laser
Caries Detector |
K051909 |
|
Heeyoung Co. Ltd (Korea) |
LCD
Monitors for Cardiology |
K052120 |
|
Connectables LLC |
Breath
Alcohol Tester |
K052448 |
|
Shanghai
Fimet (China) |
Dental
Chair with Operative Unit |
K052470 |
|
|
Diagnostic
X-Ray System |
K052541 |
|
Biospace (Korea) |
Body
Composition Monitors |
K052646 |
|
Mikasa (Japan)/MinXray |
Portable
X-Ray |
K052721 (Special) |
|
Cardiocom LLC |
Non-invasive
automated blood pressure meter. |
K053303 and K053304 |
|
Waldmann Lighting |
Surgical
Lamp |
K053364 |
|
Scorpion
(France) |
Ultrasonic
Scaling Inserts |
K053578 |
|
Diagnostic
Devices Inc. |
Blood
Glucose Meter |
K053593 |
|
KaVo Dental Corporation |
Subgingival Dental Calculus
Detector (Laser) |
K060080 (Special) |
|
KaVo Dental Corporation |
Dental
Imaging System |
K060178 |
|
Implant
Logic Systems |
Dental
Implant Planning Software |
K060267 |
|
B&L
Biotech Co. Ltd (Korea) |
Gutta Percha Gun |
K060347 |
|
MBL
International Corporation (Japan) |
ELISA
Kit |
K060431 |
|
Diagnostic
Devices Inc. |
Blood
Glucose Meter |
K060467 |
|
Mikasa (Japan)/MinXray |
Podiatric
X-Ray |
K060566 (Special) |
|
OMI
(Australia) |
Safety
Syringe |
K060971 |
|
Medical
Devices/Padpro |
Defibrillator
Tester |
K061606 |
|
Sedecal
(Spain) |
Diagnostic
X-Ray System |
K062335 (Special) |
|
Pishon High Tech Co., Ltd
(Korea) |
Electronic
Stethoscope |
K062481 |
|
RMI,
Incl. |
Breath
Alcohol Detector |
K062545 |
|
Resource
Management International LLC |
Breath
Alcohol Detector |
K062545 |
|
BioSpace
Corp. Ltd. ( |
Body
Composition Analyzer |
K062603 |
|
Virtual
Imaging |
Mobile
Digital X-Ray System |
K063262 |
|
GE
Medical |
Digital
X-Ray System |
K063283 |
|
Daejin (Korea) |
Insulin
Syringe |
K063348 |
|
Daejin (Korea) |
Insulin
Pen Needle |
K063466 |
|
Amann Girrbach (Austria) |
Dental
Material |
K063511 |
|
Yoshida
(Japan) |
Dental
CT |
K063622 |
|
KaVo Dental Corporation |
Dental
Material |
K063624 |
|
Synvasive Technology Inc |
Knee
Implant Adjustment Tool |
K070108 |
|
Eemagine Medical Imaging
Solutions (Germany) |
EEG
Software |
K070358 |
|
Virtual Imaging |
Digital
Fluoroscopic Camera |
K070390 |
|
CDL
Technologies Inc |
Dental
Material |
K070537 |
|
Feel Tech (Korea) |
Insulin Syringe |
K070917 |
KHN Solutions
|
Breath Alcohol
Detector |
K071067 |
|
Vidar Systems Corp |
Digital
X-Ray System |
K071193 (Special) |
MBL International
Corp (Japan)
|
IVD Elisa Kits |
K071961 |
MI Tech Co. Ltd
(Korea)
|
Esophageal Stent |
K072094 |
|
Airistar |
Medical Air
Purifier |
K072185 |
|
CRS Medical |
Fibrin Analysis
Catheter Test System |
K072518 |
|
Dooyang Systems (Korea) |
LCD Monitors |
K072532 |
|
Takara Belmont
(Japan) |
Cone Beam CT |
K072574 |
|
Almana Medical
(Saudi Arabia) |
Diagnostic X-Ray
Systems |
K072659 |
|
Ralco (Italy) |
X-Ray Collimator,
Automatic |
K072780 |
|
Kavo (Germany) |
Surgical Laser |
K073074 |
|
IMIX ADR (Finland) |
Digital X-Ray
System |
K073114 |
|
EBI, Inc. (Korea) |
Endosseous Implant |
K073116 |
|
AIIA Communication
Inc. (Korea) |
Body Composition
Analyzer |
K073227 |
|
Fujifilm Medical
Systems |
Digital X-Ray
System |
K073650 |
|
FIM Medical
(France) |
CO Tester |
K080278 |
|
The Ashley
Collection |
Key Ring Alcohol
Tester |
K080286 |
|
Meinntech CO., LTD (Korea) |
Intravascular
Administration Set |
K080303 |
|
Ralco
s.r.l. (Italy) |
X-Ray
Collimator, Automatic |
K080329 |
|
Medicatech USA |
Digital
X-Ray Systems |
K080582 |
|
MAC
Medical |
Irrigation
Solution Warmer |
K080609 |
|
Almana
Medical Imaging (Saudi Arabia) |
Digital
X-Ray System |
K080614 |
|
Almana
Medical Imaging (Saudi Arabia) |
Fluoroscopy
System |
K080847 |
|
Q3
Innovations |
Breath
Alcohol Detector |
K080848 |
|
Feel
Tech (Korea) |
Insulin
Pen Needle |
K080904 |
|
Elekta Neuromag OY (Finland) |
EEG
with Filter |
K081430 |
|
Warantec Co. Ltd (Korea) |
Dental Implant System |
K081748 |
|
Amplivox (UK) |
Auditory
Impedance Tester |
K081841 |
|
Almana
Medical Imaging (Saudi Arabia) |
Diagnostic
X-Ray Systems |
K082064 |
|
dxRAD (Canada) |
Digital
X-Ray Systems |
K082261 |
|
Viztek
|
Digital
X-Ray Systems |
K082604 |
|
Minxray |
Digital
X-Ray Systems |
K082627 |
|
Medicatech USA |
Digital
X-Ray Systems |
K082798 |
|
Suinsa
(Spain) |
Diagnostic
X-Ray Systems |
K083109 |
|
Stingray Surgical Products |
Electrosurgical Forceps |
K083162 |
|
Virtual
Imaging |
Fluoroscopic
C-Arm |
K083725 |
|
KHN
Solutions |
Breath
Alcohol Tester |
K083801 |
|
Ljungberg-Kogel (Sweden) |
Wireless
Option for Bloodbank Scale/Mixer |
BK090010 |
|
KHN
Solutions |
Breath
Alcohol Tester |
K090061 |
|
KHN
Solutions |
Breath
Alcohol Tester |
K090067 |
|
Sedecal
(Spain) |
Digital
X-Ray Systems |
K090238 |
|
Sedecal
(Spain) |
Digital
X-Ray Systems |
K090279 |
|
Sedecal
(Spain) |
Modified
Mobile X-Ray (Film and Digital) |
|
|
Minxray (Japan) |
Dental X-Ray |
K091255 |
|
Elekta Neuromag
OY (Finland) |
Source Localization Software |
K091393 |
|
Silver Bay LLC |
Light Therapy Device |
K091467 |
|
Masters
Healthcare |
Insulin
Syringes |
K091474 |
|
Ralco
s.r.l. (Italy) |
X-Ray
Collimator, Automatic |
K091517 |
|
Viztek |
Digital Stationary X-Ray |
K091752 |
|
Eidosmed |
Electronic Depth Gauge |
K091992 |
|
Nidacon International AB (Sweden) |
Reproductive Media |
K092107 |
|
Virtual Imaging (Canon) |
Radiographic Printer |
K092280 |
|
GN Otometrics (Denmark) |
Evoked Response System |
K092373 |
|
Virtual Imaging (Canon) |
Digital Fluoroscopic Panel |
K092439 |
|
Biospace Corporation LTD (Korea) |
Body Composition Analyzer |
K092786 |
|
Synvasive Technology |
Intraoperative Orthopedic Joint Assessment Aid |
K093046 |
|
MEDSYNAPTIC PRIVATE, LTD (India) |
PACS Software |
K093247 |
|
Lumos, Inc |
Collimator |
K093596 |
|
Virtual Imaging (Canon) |
Digital Fluoroscopic System |
K093688 |
|
Almana Medical Imaging (Saudi Arabia) |
Digital Mobile X-Ray |
K100001 |
|
Xceram USA |
Dental Material |
K100250 |
|
Minxray (Japan) |
Digital Mobile X-Ray |
K100449 |
|
Brain Tunnelgenix Technologies |
Electronic Clinical Thermometer |
K100843 |
|
Imix ADR Finland OY (Finland) |
Digital Stationary X-Ray |
K101435 |
|
Viztek |
Digital Stationary X-Ray |
K102123 |
|
MHC Medical Products |
Piston Syringe |
K102178 |
|
Stephanix Radiological Systems (France) |
Digital Fluoroscopic System |
K102529 |
|
Sedecal (Spain) |
Portable X-Ray |
K103522 |
|
Panoramic Corp |
Digital Panographic Dental X-Ray |
K110371 |
Revised April
2011