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) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) EAR, Medline product number/SKU DYNJ909020B;
2) EAR, Medline product number/SKU DYNJ909020A;
3) CAROTID PACK, Medline product number/SKU DYNJ42922C Open, Classified |
OGR | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) PEDS SINUS PACK, Catalog Number: DYNJ02516G;
2) SINUS PACK-LF, Catalog Number: DYNJ0342705J;
3) NASAL-LF, Catalog Number: DYNJ40094G;
4) ENT PACK, Catalog Number: DYNJ5 Open, Classified |
OGR | None listed |
| Sep 18, 2026 | Medline Industries, LP Medline convenience kits containing Healthmark Instrument Channel Brushes.
SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F. Open, Classified |
OGR | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX;
2) KIT, ENT HARVEST , Catalog Number: Open, Classified |
OGR | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S Open, Classified |
OGR | None listed |
| Aug 21, 2026 | Medline Industries, LP Medline medical convenience kits, labeled as:
1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F;
2) ENT PACK, Medline Kit SKU DYNJ40154D;
3) ENT PACK, Medline Kit SKU DYNJ40154F;
4) ENT SCOPE PACK, Open, Classified |
OGR | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) ENT TRAY , Catalog Number: 24-0726A;
2) KIT,SINUS , Catalog Number: PE13SPAJA;
3) KIT,SINUS , Catalog Open, Classified |
OGR | None listed |
| Jul 24, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) ENT Pack, Pack Number AMS12206;
2) ENT Pack, Pack Number AMS15517;
3) ENT Facial Pack, Pack Number AMS15863A. Open, Classified |
OGR | None listed |
| Jul 1, 2026 | Windstone Medical Packaging, Inc. A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit Open, Classified |
OGR | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as:
ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products) Open, Classified |
OGR | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
DISCECTOMY PACK
DYNJ86476B
EAR
DYNJ81460C
DYNJ900004J
DYNJ901779J
DYNJ902900F
EAR PACK
DYNJ81419D
ENT PACK
DYNJ40498B
HEAD & NECK CDS
DYNJ901246J
JEWISH DR SEVERTSON EA Open, Classified |
OGR | None listed |
| May 8, 2026 | Medline Industries, LP Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B Open, Classified |
OGR | None listed |
| May 7, 2026 | Medline Industries, LP See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Numbe Open, Classified |
OGR | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc. Open, Classified |
OGR | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
MINOR ENT SINUS PACK-LF
DYNJ0101278F
DYNJ0101278G
DYNJ0101278I
SINUS PACK DYNJ56262 Open, Classified |
OGR | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) ENT PACK, Model Number: DYNJ59030B;
2) ENT, Model Number: DYNJ908586C;
3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C Open, Classified |
OGR | None listed |
| Apr 7, 2026 | Medline Industries, LP Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K;
2. Open, Classified |
OGR | None listed |
| Apr 1, 2026 | Medline Industries, LP Medline kits containing Olympus biopsy valves:
1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G
2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J
3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A
4. RIGID KIT Open, Classified |
OGR | None listed |
| Feb 20, 2026 | Medline Industries, LP Medline Convenience Kits:
1) NAIL KIT, Model Number: POD14214 Open, Classified |
OGR | K112666 |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G;
2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I;
3) HEAD & NECK CDS-LF, Model Number: CDS983782C;
4) BAP Open, Classified |
OGR | None listed |
| Jan 28, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) MIDDLE EAR CDS, Kit SKU CDS984347O;
2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N;
3) NECK PACK-LF, Kit SKU DYNJ0966130K;
4) NECKLINE PACK- Open, Classified |
OGR | None listed |
| Jan 12, 2026 | Medline Industries, LP Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R;
2) RR-ASC EAR PACK-LF, Medline Kit SK Open, Classified |
OGR | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) HEAD AND NECK, REF CDS984259O;
2) HEAD AND NECK, REF CDS984259P;
3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F;
4) MAJOR ENT HARPER PACK-LF, REF DYNJ016171 Open, Classified |
OGR | None listed |
| Nov 13, 2025 | Medline Industries, LP Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;
ENT
DYNJ909128I;
LARYNGOSCOPY - BRONCHOSCOPY
DYNJ909114D Open, Classified |
OGR | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
RCEN25B ENT SDSC 0246972
RCHN27D HEAD AND NECK RCH 0246951 Open, Classified |
OGR | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792 Open, Classified |
OGR | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) T A PACK, Model Number: DYNJ67791A;
2) NASAL PACK, Model Number: DYNJ66514;
3) ENT PACK, Model Number: DYNJ67775A;
4) T/A ENDO PACK, Model Open, Classified |
OGR | None listed |
| Mar 26, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C;
2) BLEPH/RHINO PACK, Pack Number DYNJ64669A;
3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C;
4) DENTAL Open, Classified |
OGR | None listed |
| Mar 14, 2025 | MEDLINE INDUSTRIES, LP - Northfield Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. Open, Classified |
OGR | None listed |
| Mar 14, 2025 | American Contract Systems Inc EAR PACK
, Model No SFEA12A Open, Classified |
OGR | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4;
2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5
3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Numb Open, Classified |
OGR | None listed |
| Jan 15, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
0 ) DESCRIPTION Catalog Number: CATALOG #;
1 ) KIT, NASAL , Catalog Number: PE23NSMEA;
2 ) KIT, NASAL , Catalog Number: PE23NSMEC;
3 ) KIT,SEPTOPLASTY NEW HAN Open, Classified |
OGR | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield See DocMan Open, Classified |
OGR | None listed |
| Dec 20, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS Open, Classified |
OGR | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand medical procedure convenience kits, labeled as:
1) T&A CDS-LF, REF CDS982091I;
2) TONSIL CDS, REF CDS984492B;
3) RV T&A PACK-LF, REF DYNJ0798129I;
4) DIRECT MICRO LARYNG PK-LF, REF Open, Classified |
OGR | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit Open, Classified |
OGR | None listed |
| Oct 8, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. Open, Classified |
OGR | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Nasal Sinus Pack, MTSN26B; Medical convenience kit Open, Classified |
OGR | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. ENT, COEN27N; Medical convenience kit Open, Classified |
OGR | None listed |
| Sep 11, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D;
b) ENT MINOR, Pack Number DYNJ908099B;
c) HEAD & NECK, Pack Nu Open, Classified |
OGR | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) HEAD & NECK TRAY, Pack Number AM310B ;
2) HEAD & NECK CDS , Pack Number CDS780161K ;
3) HEAD & NECK CDS , Pack Number CDS780161L ;
4) HEAD & NECK PROCEDURE Open, Classified |
OGR | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure packs, containing Caina syringes, labeled as:
1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920;
2) RETINAL INJECTION KIT, Pack Number MNS12465 Open, Classified |
OGR | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) TYMPANOPLASTY , Pack Number CDS980203S;
2) MAJOR EAR , Pack Number CDS982016T;
3) MAJOR EAR PACK, Pack Number CMPJ01846O;
4) EAR PACK, Pack Number CMPJ05884 Open, Classified |
OGR | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure kits labeled as:
1) BIOPSY KIT, Pack Number DYNDA1466A;
2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;
3) CHEST TUBE INSERTION TRAY, Pack Number CHT560;
4) CUSTOM BIOPS Open, Classified |
OGR | None listed |
| Aug 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits labeled as follows:
a) BASIC NASAL, REF DYNJ909932;
b) BRONCH KIT, REF DYKE1007B;
c) ENT, REF DYNJ909935;
d) NASAL SINUS-LF, REF DYNJ902624G;
e) ORAL, REF DYNJ902 Open, Classified |
OGR | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Kits, trays, and packs labeled as follows:
a) ASC MINOR THYROID CDS, REF CDS983682F;
b) BRONCHOSCOPY KIT, REF DYKE1718A;
c) BRONCHOSCOPY KIT, REF DYKE1718B;
d) DOUBLE CENTRAL LINE CAP CHA Open, Classified |
OGR | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Custom procedural convenience kits and trays, ear, nose & throat, labeled as:
a) T AND A PACK AGH ASC, kit number AGTA48J;
b) OPSC EAR PACK, kit number LLEO66;
c) T AND A PACK, kit number MMTA41F Open, Classified |
OGR | None listed |
| Oct 10, 2023 | Cardinal Health 200, LLC Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile. Open, Classified |
OGR | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. CAROTID, Model Number: DYNJ54287A;
b. CAROTID PACK, Model Number: DYNJ66190;
c. Open, Classified |
OGR | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I;
b) HEAD AND NECK PACK, Model Number DYNJ30245;
c) IR T Open, Classified |
OGR | None listed |
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