FDA 510(k) Applications Submitted by DANIEL HOEFER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010046 |
01/05/2001 |
NUVOLASE 532 MEDICAL LASER SYSTEM |
AMERICAN LASER CORP. |
| K160275 |
02/02/2016 |
Fuse Endoscopic System with FuseBox Processor |
EndoChoice Inc. |
| K160403 |
02/12/2016 |
SmartStart Air/Water and Suction Valves |
ENDOCHOICE, INC. |
| K970667 |
02/24/1997 |
NUVO-LASE 660 LASER SYSTEM |
AMERICAN LASER MEDICAL |
| K990665 |
03/02/1999 |
BQ/BM INTEGRATED LASER DELIVERY SYSTEM |
AMERICAN LASER CORP. |
| K990780 |
03/09/1999 |
NUVOLASE 532 CUTANEOUS LASER SYSTEM |
AMERICAN LASER MEDICAL |
| K091186 |
04/23/2009 |
KODAK 1500 INTRAORAL CAMERA |
CARESTREAM HEALTH, INC. |
| K161167 |
04/26/2016 |
Seal Single-Use Biopsy Valve |
ENDOCHOICE, INC. |
| K001511 |
05/15/2000 |
O-LAS OPHTHALMIC PHOTODISRUPTOR |
A.R.C. LASER AG |
| K111423 |
05/23/2011 |
CS 1600 INTRAORAL CAMERA |
CARESTREAM HEALTH,INC. |
| K111649 |
06/13/2011 |
CS 7600 |
CARESTREAM HEALTH, INC. |
| K131991 |
06/28/2013 |
ENDOCHOICE HOT BIOPSY FORCEPS |
ENDOCHOICE, INC. |
| K972561 |
07/09/1997 |
NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY |
AMERICAN LASER MEDICAL |
| K972765 |
07/24/1997 |
NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER |
AMERICAN LASER MEDICAL |
| K152182 |
08/05/2015 |
Fuse Gastroscopy System |
ENDOCHOICE INC. |
| K142155 |
08/06/2014 |
ENDOCHOICE WATER BOTTLE CAP SYSTEM |
ENDOCHOICE, INC. |
| K122427 |
08/09/2012 |
CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE |
CARESTREAM DENTAL LLC |
| K112321 |
08/12/2011 |
CS 1200 |
CARESTREAM HEALTH,INC. |
| K132535 |
08/13/2013 |
AUTOBAND LIGATOR |
ENDOCHOICE, INC. |
| K132776 |
09/05/2013 |
SEAL BIOPSY VALVE - REUSABLE |
ENDOCHOICE, INC. |
| K132839 |
09/10/2013 |
FUSE 1C COLONOSCOPY SYSTEM |
ENDOCHOICE, INC. |
| K152580 |
09/10/2015 |
rescuenet |
ENDOCHOICE, INC. |
| K993154 |
09/21/1999 |
LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM |
A.R.C. LASER CORP. |
| K002986 |
09/25/2000 |
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 |
A.R.C. LASER AG |
| K043104 |
11/09/2004 |
KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 |
PRACTICEWORKS, INC. |
| K003512 |
11/14/2000 |
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II |
A.R.C. LASER AG |
| K133747 |
12/09/2013 |
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM |
ENDOCHOICE, INC. |
| K153588 |
12/16/2015 |
EndoChoice Water Bottle Cap System |
ENDOCHOICE, INC. |
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