FDA.reportPublic FDA data

Search

107 matching records for SINGLE J.

NDC#

Sunmark Saline Single

Strategic Sourcing Services LLC

Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form

HealthMart Saline Single

Strategic Sourcing Services LLC

Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form

QUALITY CHOICE SINGLE SALINE

Alcyon Health, LLC.

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

Pro-Enema Single Saline

Propharma Medical Supplies

Sodium Phosphate, Dibasic and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

DailyMed#

Adderall XR

Takeda Pharmaceuticals America, Inc. | Cambrex Charles City, Inc | Patheon Manufacturing Services LLC | Unither Manufacturing LLC | Sharp Packaging Services, LLC

20260430

MYDAYIS

Takeda Pharmaceuticals America, Inc. | Cambrex Charles City, Inc | Patheon Manufacturing Services LLC

20260430

Single-Use

Covetrus|Pegasus Laboratories, Inc|Macco Organiques, Inc

2025-12-31

GMDN Terms#

Peripheral anaesthesia single-administration set, non-medicated

1,990 GUDID devices

A collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes an anaesthesia needle and a syringe often with additional devices u...

Peripheral anaesthesia single-administration set, medicated

1,582 GUDID devices

A collection of devices intended for the single-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent with an anaesthesia needle and a syringe often with additional devices utilized fo...

Peripheral anaesthesia single-administration set, non-medicated

538 GUDID devices

A collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dr...

Endoscopic manual linear cutting stapler, single-use

326 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...

Single-chamber venous compression system garment, reprocessed

292 GUDID devices

A non-sterile, inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent...

Single-chamber venous compression system garment, single-use

251 GUDID devices

An inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent inflation o...

Open-surgery manual linear cutting stapler, single-use

136 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...

Open-surgery manual linear stapler, single-use

55 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 application of surgical staples to approximate internal soft tissues (e.g., two ends of b...

Single-lumen haemodialysis catheter, peripheral vascular

18 GUDID devices

A sterile, flexible, single-lumen tube intended to be used for short-term (< 30 days) peripheral arteriovenous access during extracorporeal blood therapies (i.e., haemodialysis haemoperfusion and/or apheresis), to conduct blood from a patient and to return ...

Surgical clip applier, single-use

18 GUDID devices

A hand-held manual surgical instrument designed to apply small atraumatic clips for the ligation of blood vessels, or similar tubular anatomy, mainly to stop and/or prevent bleeding (i.e., haemostasis) during an open-surgery procedure. The device is typical...

Endoscopic manual linear cutting stapler, reprocessed

6 GUDID devices

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

Dental implant suprastructure, temporary, preformed, single-use

16,494 GUDID devices

A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue heal...

Vascular guide-catheter, single-use

7,945 GUDID devices

A sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular syste...

Polyolefin suture, monofilament

4,495 GUDID devices

A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision ...

Coronary angioplasty balloon catheter, basic

3,691 GUDID devices

A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that ...

Vascular guide-catheter, single-use

3,305 GUDID devices

A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may...

Vascular guide-catheter, single-use

2,988 GUDID devices

A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system....

Nylon suture, non-bioabsorbable, monofilament

2,838 GUDID devices

A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached need...

Orthodontic archwire/bracket ligature

2,729 GUDID devices

A device intended to securely tether an orthodontic archwire to an orthodontic bracket, or securely hold the archwire in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie, or a circular band made of elastomeric ...

Orthodontic bracket, plastic, single-use

2,547 GUDID devices

A plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used f...

Laparoscopic access cannula, single-use

2,274 GUDID devices

A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and o...

Orthodontic archwire/bracket ligature

1,573 GUDID devices

A device intended to hold an orthodontic archwire securely in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie or circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a sin...

Ophthalmic knife, single-use

1,523 GUDID devices

A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip ...

CPAP/BPAP face mask, single-use

1,512 GUDID devices

A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambie...

Single-administration urethral catheterization kit, single-use

1,379 GUDID devices

A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient...

Hand/finger splint, single-use

1,309 GUDID devices

A rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fast...

Surgical/emergency suction cannula, non-illuminating, single-use

1,274 GUDID devices

An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intr...

General-purpose absorbent tip applicator/swab, single-use

1,260 GUDID devices

A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orific...

Laparoscopic access cannula, reprocessed

1,221 GUDID devices

A sterile, single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/flui...