Panels › Ear, Nose, Throat › Product code OGR · Class 1
Ear, Nose, And Throat Surgical Tray
Regulation 874.4420
0510(k)s in 12 months (0 all time)
24recalls in 12 months (77 all time)
1recalls that name a 510(k)
Top companies in OGR
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470 Open, Classified |
OGR | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. EAR CDS-LF
b. SINUS CDS-1
c. ZALE FESS CDS
d. ZALE OTOLOGY CDS
e. ZALE HEAD & NECK CDS
f. CUH PARA/THYROIDECTOMY CDS
g. CAM ENDOSCOPIC SINUS/SEP Open, Classified |
OGR | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742 Open, Classified |
OGR | None listed |
| Nov 23, 2022 | ROi CPS LLC regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit Terminated |
OGR | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various ENT Packs Open, Classified |
OGR | None listed |
| Jun 6, 2022 | MEDLINE INDUSTRIES, LP - SPT Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927
Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927 Open, Classified |
OGR | None listed |
| Nov 30, 2021 | ROi CPS LLC Regard, T AND A - Rogers, sterilized convenience kits Terminated |
OGR | None listed |
| Aug 10, 2021 | ROi CPS LLC REGARD Ear Tray Terminated |
OGR | None listed |
| Nov 13, 2020 | Medline Industries Inc Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries. Terminated |
OGR | None listed |
| Nov 13, 2020 | Medline Industries Inc Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries. Terminated |
OGR | None listed |
| Apr 13, 2020 | American Contract Systems Sterile Custom Packs to be used in surgical procedures. Terminated |
OGR | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- ENT
SNUF3 SNUFFER KIT Y Terminated |
OGR | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Nasal Speculum
NSP500ST STERILE NASAL SPECULUM Terminated |
OGR | None listed |
| Jun 24, 2019 | Centurion Medical Products Corporation NOSEBLEED TRAY
Kit Code: MNS3885 Terminated |
OGR | None listed |
| Jun 24, 2019 | Centurion Medical Products Corporation YNHH SCOPE KIT
Kit Code: MNS10475 Terminated |
OGR | None listed |
| Jun 24, 2019 | Centurion Medical Products Corporation EPISTAXIS TRAY
Kit Code: MNS10165 Terminated |
OGR | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001482
ENT SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OGR | None listed |
| Sep 3, 2015 | Customed, Inc EENT PACK I (1) 10/CS CUSTOMED
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OGR | None listed |
| Sep 3, 2015 | Customed, Inc EAR PACK 3/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OGR | None listed |
| Sep 3, 2015 | Customed, Inc EAR PACK 3/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OGR | None listed |
| Sep 3, 2015 | Customed, Inc E.N.T. PK 7/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OGR | None listed |
| Dec 16, 2014 | Customed, Inc Ear Pack, catalog #900-2234
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OGR | None listed |
| Dec 16, 2014 | Customed, Inc ENT Pack, Catalog number 900-1482.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OGR | None listed |
| Aug 29, 2014 | Customed, Inc EENT PACK I
CUSTOMED
CONTENT:
(2) TOWEL ABSORBENT 15" X 20"
(1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL
(1) SHEET ENT SPLIT 110" X 77" SMS
(1) TABLE COVER REINFORCED 50" X 90" (1) D Terminated |
OGR | None listed |
| Aug 29, 2014 | Customed, Inc EAR PACK
CONTENTS:
(I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc
(2) LABEL FOR SKIN MARKERS
( I) NEEDLE HYPODERMIC 1 80 X I Y,
( I) WASI-l BASIN ROUND 6QT
(I) Terminated |
OGR | None listed |
| Aug 29, 2014 | Customed, Inc EAR PACK
CONTENTS:
( I ) B LADE SU RG ICA L # 15 CARBON STEEL
( I ) EMESI S BASIN lO in 700cc
( I ) GOWN XL SMS IM P. REINFORCED
( I ) NEEDLE HYPODERM IC 1 8G X I 'h
( I ) WASH BASIN ROU Terminated |
OGR | None listed |
| Aug 29, 2014 | Customed, Inc E..N.T. PACK -
(5) SPONGE TONSIL 7/8 XRD
(1) TABLE COVER REINFORCED 50" X 90" LIF
(1) MAYO STAND COVER REINFORCED L/F
(1) TUBE SUCTION CONNECT %" X 12' L/F
(1) CAUTERY TIP POLISHER LIF
(1) SUTURE BAG Terminated |
OGR | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.