FDA 510(k) Applications Submitted by Barry E. Sands
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190170 |
02/01/2019 |
MVP Cervical Plate System |
GS Medical Co., Ltd. |
| K031424 |
05/06/2003 |
EBI SPINELINK SPINAL FIXATION SYSTEM |
EBI, L.P. |
| K032390 |
08/04/2003 |
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM |
EBI, L.P. |
| DEN210032 |
08/09/2021 |
AccuMeasure System |
RQMIS Inc. |
| K960068 |
01/05/1996 |
SH-1 SURGICAL HOLDER FOR TELESCOPE |
OLYMPUS AMERICA, INC. |
| K060148 |
01/19/2006 |
EBI VERTEBROPLASTY SYSTEMS |
EBI, L.P. |
| K980358 |
01/29/1998 |
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM |
SYNTHES (USA) |
| K950719 |
02/16/1995 |
OES UROLOGY |
OLYMPUS AMERICA, INC. |
| K980761 |
02/27/1998 |
SYNTHES SPINE PEDIATRIC ROD SYSTEM |
SYNTHES SPINE |
| K980928 |
03/11/1998 |
SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM |
SYNTHES SPINE |
| K961048 |
03/15/1996 |
OLYMPUS MH-246R BALLOON SHEATH |
OLYMPUS AMERICA, INC. |
| K110821 |
03/24/2011 |
BARF BAND |
DOODLEBUG PRODUCTS, LLC |
| K140875 |
04/04/2014 |
OPTOSSOL COMPRESSION DEVICE SYSTEM |
GENOSSIS, LLC |
| K961611 |
04/25/1996 |
OLYMPUS BASKET GRASPERS (UROLOGY) |
OLYMPUS AMERICA, INC. |
| K951994 |
04/28/1995 |
OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER |
OLYMPUS AMERICA, INC. |
| K961860 |
05/14/1996 |
A4907 LENS CLEANING SHEATH |
OLYMPUS AMERICA, INC. |
| K971883 |
05/22/1997 |
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM |
SYNTHES (USA) |
| K101525 |
06/02/2010 |
PIONEER SPINOUS PROCESS FUSION PLATE |
PIONEER SURGICAL TECHNOLOGY |
| K962367 |
06/19/1996 |
OLYMPUS BASKET GRASPERS |
OLYMPUS AMERICA, INC. |
| K962378 |
06/20/1996 |
OLYMPUS FG-45/46-1 GRASPING FORCEPS |
OLYMPUS AMERICA, INC. |
| K962380 |
06/20/1996 |
OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) |
OLYMPUS AMERICA, INC. |
| K962387 |
06/20/1996 |
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) |
OLYMPUS AMERICA, INC. |
| K952892 |
06/23/1995 |
OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) |
OLYMPUS AMERICA, INC. |
| K962474 |
06/25/1996 |
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) |
OLYMPUS AMERICA, INC. |
| K962485 |
06/26/1996 |
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) |
OLYMPUS AMERICA, INC. |
| K962533 |
06/28/1996 |
OLYPUS FG SERIES GRASPING FORCEPS |
OLYMPUS AMERICA, INC. |
| K101790 |
06/28/2010 |
QUANTUM SPINAL SYSTEM, QUANTUM MIS |
PIONEER SURGICAL TECHNOLOGY |
| K962555 |
07/01/1996 |
OLYMPUS FB SERIES BIOPSY FORCEPS |
OLYMPUS AMERICA, INC. |
| K962901 |
07/25/1996 |
OLYMPUS B5-2C/B7-2C BALLOON CATHETER |
OLYMPUS AMERICA, INC. |
| K962925 |
07/29/1996 |
OLYMPUS B-5/B-7 SERIESBALLOON CATHETER |
OLYMPUS AMERICA, INC. |
| K963033 |
08/05/1996 |
BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES |
OLYMPUS AMERICA, INC. |
| K963160 |
08/14/1996 |
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE |
OLYMPUS AMERICA, INC. |
| K963184 |
08/14/1996 |
OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM |
OLYMPUS AMERICA, INC. |
| K954488 |
09/27/1995 |
ROLLER ELECTRODE |
OLYMPUS AMERICA, INC. |
| K955066 |
11/06/1995 |
OLYMPUS FG SERIES GRASPING FORCEPS |
OLYMPUS AMERICA, INC. |
| K955065 |
11/06/1995 |
OLYMPUS FB SERIES BIOPSY FORCEPS |
OLYMPUS AMERICA, INC. |
| K955063 |
11/06/1995 |
OLYMPUS BASKET GRASPERS |
OLYMPUS AMERICA, INC. |
| K955404 |
11/27/1995 |
OTV-S5 OES VIDEO SYSTEM |
OLYMPUS AMERICA, INC. |
| K955403 |
11/27/1995 |
OES LAPARO-THORACO VIDEOSCOPE TYPE V |
OLYMPUS AMERICA, INC. |
| K955456 |
11/29/1995 |
OES LAPARO-THORACO VIDEOSCOPE (RIGID) |
OLYMPUS AMERICA, INC. |
| K974525 |
12/02/1997 |
SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM |
SYNTHES SPINE |
| K955623 |
12/11/1995 |
OLYMPUS BIPOLAR FORCEPS |
OLYMPUS AMERICA, INC. |
| K955650 |
12/12/1995 |
OLYMPUS SD SERIES SNARES |
OLYMPUS AMERICA, INC. |
| K212038 |
06/30/2021 |
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage |
K&J Consulting Corporation |
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