FDA.reportPublic FDA data

Search

145 matching records for S-LINE.

NDC#

Linezolid

Hikma Pharmaceuticals USA Inc.

linezolid

Linezolid

Hikma Pharmaceuticals USA Inc.

Linezolid

Linezolid

Camber Pharmaceuticals, Inc.

Linezolid

Linezolid

Camber Pharmaceuticals, Inc.

Linezolid

Linezolid

Macleods Pharmaceuticals Limited

Linezolid

Linezolid

Alembic Pharmaceuticals Limited

Linezolid

Linezolid

Sun Pharmaceutical Industries, Inc.

linezolid

Linezolid

Sun Pharmaceutical Industries, Inc.

linezolid

Linezolid

Alembic Pharmaceuticals Inc.

Linezolid

Linezolid

Rising Pharma Holdings, Inc.

Linezolid

Zyvox

Pharmacia & Upjohn Company LLC

linezolid

Zyvox

Pharmacia & Upjohn Company LLC

linezolid

Zyvox

Pharmacia & Upjohn Company LLC

linezolid

Zyvox

Pharmacia & Upjohn Company LLC

linezolid

Zyvox

Hp Halden Pharma AS

LINEZOLID

Zyvox

Hp Halden Pharma AS

linezolid

Zyvox

Hp Halden Pharma AS

LINEZOLID

Medpride

Shield Line LLC

Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate

Linezolid

Teva Pharmaceuticals USA, Inc.

Linezolid

LINEZOLID

Teva Pharmaceuticals USA Inc

Linezolid

DailyMed#

Linezolid

Mylan Pharmaceuticals Inc. | Pfizer Inc | Pfizer Asia Manufacturing Pte Ltd

20260522

Zyvox

Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd | NEOLPHARMA, INC. | Pfizer Manufacturing Deutschland GmbH

20260519

Linezolid

Hospira, Inc. | Pfizer Asia Manufacturing Pte Ltd

20260513

Linezolid

Major Pharmaceuticals | Alkem Laboratories Limited

20251113

Linezolid

Ascend Laboratories, LLC | Alkem Laboratories Limited

20250613

Linezolid

Hikma Pharmaceuticals USA Inc.

20250509

Linezolid

Sun Pharmaceutical Industries, Inc.

20250217

Linezolid

Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.

20250130

Linezolid

Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit V

20250109

Linezolid

Rising Pharma Holdings, Inc. | APPCO PHARMA LLC

20241121

Linezolid

Macleods Pharmaceuticals Limited

20241010

Linezolid

Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.

20240905

Linezolid

Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED

20240706

Linezolid

Fresenius Kabi USA, LLC | HP Halden Pharma AS

20240430

Linezolid

Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited

20230915

Linezolid

American Health Packaging | Annora Pharma Private Limited

20230818

Linezolid

Alembic Pharmaceuticals Limited

20230130

Linezolid

Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited

20200826

GMDN Terms#

In-line arterial blood sampling set

167 GUDID devices

A collection of sterile devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. It is a haemodynamic pressure monitoring and blood gas sampling device, typically designed for use with disposable/reusable pressure tra...

In-line CPAP set, non-nebulizing

60 GUDID devices

A portable collection of devices intended to be connected to a medical gas supply to assist non-intubated ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory...

Inspiratory line humidification chamber, single-use

34 GUDID devices

A device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a pla...

In-line CPAP set, nebulizing

11 GUDID devices

A portable collection of devices intended to be connected to a medical gas supply to assist noninvasive ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory e...

Inspiratory line humidification chamber, reusable

10 GUDID devices

A device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a pla...

Inspiratory line humidification chamber, single-use

9 GUDID devices

A non-sterile device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases....

Surgical suction system Y-piece valve-connector

4 GUDID devices

A noninvasive tubular device intended to provide a connection between devices so that it is integrated within the tubing line of a suction assembly (e.g., of a tissue morcellation system with suction) where it can be used to introduce fluid into the suction...

Hess-screen

2 GUDID devices

A tangent screen designed for manual testing of extra ocular muscle function (i.e., strabismus). It typically consists of a series of lines (Hess coordinates) configured in small sections in a curved pin-cushion pattern (i.e., the middle of the lines is clo...

Intravenous line connector disinfection scrubber

2 GUDID devices

A hand-held device intended to be used to manually disinfect an in-line connector of an intravenous line (e.g., catheter injection port, needleless valve, Luer access valve) with scrubbing to reduce the risk of infection between intravenous administrations....

Pneumatic line tester, battery-powered

2 GUDID devices

A portable, battery-powered, general-purpose device intended to measure pneumatic line flow rates and pressures (positive and negative) in order to calibrate or test a medical (e.g., anaesthesia machines, suction devices) or industrial device and is not ded...

Craniotomy power tool system handpiece, line-powered

1 GUDID devices

A hand-held device which is a component of a line-powered (AC-powered) craniotomy system or multi-purpose line-powered surgical power tool system, intended to be used to rotate a cranial cutting tool (i.e., a drill bit, bur, trephine or perforator) in order...

Radiology picture archiving and communication system workstation

567 GUDID devices

A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance im...

Cell culture line IVD

401 GUDID devices

A cell line of known origin intended to be used alone or in combination with other IVDs, for cytogenetic analyses and/or for the detection/cultivation of viruses present in clinical laboratory specimens.

Stationary panoramic/tomographic dental x-ray system, digital

392 GUDID devices

A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity...

Surgical power tool system control unit, line-powered

343 GUDID devices

A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions...

Intravenous line recessed-needle connector

212 GUDID devices

A sterile device designed to allow access to either the Y-site of an intravenous (IV) line or an injection adaptor on the infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard septum and a Luer fitting locat...

Endoscopic manual linear cutting stapler, single-use

194 GUDID devices

A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecologic, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may als...

Surgical power tool system handpiece, sawing, line-powered

193 GUDID devices

A hand-held, line-powered device (which may in addition include a rechargeable battery) that consists of a motorized saw handpiece intended to provide sagittal, oscillating, or reciprocating movement for attachable serrated blades designed to cut through ha...

Neutral-pressure intravenous line needleless valve-connector

177 GUDID devices

A small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position...

Luer/Luer linear connector, single-use

175 GUDID devices

A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape;...

Accelerator system quality assurance device

171 GUDID devices

An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments u...

Stationary x-ray grid

133 GUDID devices

A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" ar...

Linear accelerator system

123 GUDID devices

An assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam wit...

Line-powered surgical power tool system motor

96 GUDID devices

A compact line-powered engine (that may include a rechargeable battery) intended to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures that include drilling, sawing, and inserting involving bones and...

Open-surgery manual linear cutting stapler, single-use

78 GUDID devices

A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device oper...

Tissue morcellation system handpiece, line-powered

65 GUDID devices

A hand-held component of a tissue morcellation system intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery. It consists of a high-speed rotating blade in a h...

Intravenous line filter

59 GUDID devices

A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.

Intravenous fluid bag spike

38 GUDID devices

A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other ...

Accelerator system table, non-powered

37 GUDID devices

A non-electrical radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during therapeutic radiation treatments administered using a medical linear accelerator or non-linea...

Cardiopulmonary bypass system filter, arterial blood line

37 GUDID devices

A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e....