Medtronic Xomed, Inc.

Jacksonville, FL, US

MEDTRONIC XOMED, INC. appears in FDA device records in Jacksonville, FL. FDA records list 46 510(k) clearances between 1996-09-23 and 2026-02-10, 9 PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 38 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 46
PMA records: 9
Recall records: 38
Registered establishments: 2

510(k) clearance history

FDA records hold 46 510(k) clearances for Medtronic Xomed, Inc. between 1996 and 2026. The busiest year on record is 2001, with 4. The most recent is 2026, with 1.

Clearances by year, as a table

510(k) clearance decisions for Medtronic Xomed, Inc., by decision year
Year	Clearances
1996	1
1997	1
1999	1
2000	3
2001	4
2002	2
2003	3
2004	4
2005	1
2006	2
2008	4
2009	1
2011	1
2012	4
2013	2
2015	4
2018	1
2020	2
2021	1
2022	1
2023	2
2026	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K251672	NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)	ETN	Substantially Equivalent	2026-02-10
K230320	NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube	ETN	Substantially Equivalent	2023-10-26
K231580	NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)	ETN	Substantially Equivalent	2023-08-30
K213246	NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long	ETN	Substantially Equivalent	2022-03-21
K210841	NuVent Eustachian Tube Dilation Balloon	PNZ	Substantially Equivalent	2021-08-16
K202623	Novapak Nasal Sinus Packing and Stent	LYA	Substantially Equivalent	2020-12-08
K200759	NIM Vital, Nerve Integrity Monitor	GWF	Substantially Equivalent	2020-10-28
K173855	Sharpsite AC Rigid Endsocope	EOB	Substantially Equivalent	2018-04-20
K152121	NuVent EM Sinus Dilation System	LRC	Substantially Equivalent	2015-12-01
K151758	ALAR Nasal Valve Stent	GAT	Substantially Equivalent	2015-10-29
K150728	XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole	ERL	Substantially Equivalent	2015-08-14
K151067	Ventilation (Tympanostomy) Tubes	ETD	Substantially Equivalent	2015-07-22
K132297	EM SINUS DILATION SYSTEM	LRC	Substantially Equivalent	2013-11-05
K122391	MEDTRONIC XOMED, INC.	LRK	Substantially Equivalent	2013-01-10
K122434	MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL	NHB	Substantially Equivalent	2012-10-31
K112686	NEXT GEN EMG ENDOTRACHEAL TUBE	ETN	Substantially Equivalent	2012-06-27
K110623	PILLAR PALATAL IMPLANT SYSTEM	LRK	Substantially Equivalent	2012-02-10
K112662	MICROFRANCE(R) WORMALD VASCULAR CLAMP	DXC	Substantially Equivalent	2012-01-20
K111520	IPC POWEREASE SYSTEM	HBE	Substantially Equivalent	2011-10-26
K083124	NIM 3.0	GWF	Substantially Equivalent	2009-02-27
K081475	ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]	HBE	Substantially Equivalent	2008-10-17
K081277	XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)	ERL	Substantially Equivalent	2008-09-05
K080257	MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS	GCJ	Substantially Equivalent	2008-05-22
K073255	XPS 3000 SYSTEM	ERL	Substantially Equivalent	2008-03-24
K063305	STIMULATING BUR GUARD	ETN	Substantially Equivalent	2006-11-29
K053430	TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER	HKY	Substantially Equivalent	2006-03-03
K050162	CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE	ETN	Substantially Equivalent	2005-03-03
K041381	MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT	LYA	Substantially Equivalent	2004-09-10
K041985	XPS CURVED BUR	EQJ	Substantially Equivalent	2004-08-12
K041523	XPS 3000 SYSTEM	ERL	Substantially Equivalent	2004-07-23
K041413	XPS 3000 SYSTEM	ERL	Substantially Equivalent	2004-07-12
K031510	NIM-SPINE	ETN	Substantially Equivalent	2003-06-18
K031003	STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES	ETN	Substantially Equivalent	2003-04-11
K024316	NIM-PRS	IKN	Substantially Equivalent	2003-01-06
K022370	FRAMELOCK; FRAMELOCK ACCESSORIES	HBG	Substantially Equivalent	2002-10-18
K014165	STIMULUS - DISSECTION INSTRUMENTS	ETN	Substantially Equivalent	2002-01-22
K011321	MODIFICATION TO XPS 3000 SYSTEM	ERL	Substantially Equivalent	2001-06-26
K011191	MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES	HOZ	Substantially Equivalent	2001-06-26
K010677	XPS 3000 SYSTEM	HRX	Substantially Equivalent	2001-05-07
K010666	XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE	QPB	Substantially Equivalent	2001-05-07
K002972	MEROGEL CONTROL GEL ENT SURGICAL DRESSING	KHJ	Substantially Equivalent	2000-12-15
K002224	XPS 3000 SYSTEM	ERL	Substantially Equivalent	2000-12-04
K000728	MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE	FST	Substantially Equivalent	2000-03-21
K990793	ACCUGUIDE MUSCLE INJECTION MONITOR	GXZ	Substantially Equivalent	1999-10-22
K963727	HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER	ETD	Substantially Equivalent	1997-02-11
K963246	TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT	ERL	Substantially Equivalent	1996-09-23

Registered establishments

FDA registered establishments for Medtronic Xomed, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1045254	1045254	MEDTRONIC XOMED, INC.	6743 SOUTHPOINT DR. NORTH, Jacksonville, FL 32216 US	2026	BSR BTR EMX EOB EOX EPP EPW EQJ ERL ESZ and 71 more, listed in full below
1219071	1000159144	MEDTRONIC XOMED, INC.	950 Flanders Rd, Mystic, CT 06355 US	2026	EFQ EMX HBA HOZ KCN LYA NAB

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Showing 25 of 38

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2461-2025	IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.	Due to out of the box wobble of the driver.	Class II	2025-07-17	Open, Classified
Z-1623-2025	NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164	Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.	Class II	2025-03-10	Open, Classified
Z-3130-2024	Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069	Product was distributed past expiration date.	Class II	2024-07-05	Open, Classified
Z-2409-2024	NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143	Potential for false negative response on the NIM Vital Nerve Monitoring System	Class I	2024-06-24	Open, Classified
Z-0696-2024	NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK	Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,	Class II	2023-11-07	Open, Classified
Z-1224-2022	NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2	Software anomaly was identified.	Class II	2022-05-03	Open, Classified
Z-1223-2022	NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2	Software anomaly was identified.	Class II	2022-05-03	Open, Classified
Z-1521-2022	NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J	The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.	Class I	2022-04-29	Open, Classified
Z-1520-2022	NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306	The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.	Class I	2022-04-29	Open, Classified
Z-1519-2022	NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506	The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.	Class I	2022-04-29	Open, Classified
Z-0743-2022	NIM TRIVANTAGE EMG Endotracheal Tube	There is potential for multiple issues due to a manufacturing nonconformity.	Class II	2021-12-22	Open, Classified
Z-0961-2022	Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300	As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.	Class II	2021-12-15	Terminated
Z-0158-2022	Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Blade, 25 cm x 4.0 mm; (6) REF 45A2000, Nucleus Removal Angled Blade, 20 cm x 4.5 mm; (7) REF 45A2500, Nucleus Removal Angled Blade, 25 cm x 4.5 mm; (8) REF 45R2000, Nucleus Removal Set, 20 cm x 4.5 mm; (9) REF 45R2500, Nucleus Removal Set, 25 cm x 4.5 mm; (10) REF 45S2000, Nucleus Removal Straight Blade, 20 cm x 4.5 mm; (11) REF 45S2500, Nucleus Removal Straight Blade, 25 cm x 4.5 mm.	There was an increase in complaints related to tip breaks and wobble/vibration.	Class II	2021-08-31	Open, Classified
Z-0157-2022	Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.	There was an increase in complaints related to tip breaks and wobble/vibration.	Class II	2021-08-31	Open, Classified
Z-0156-2022	Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6) REF 1884033, Tracheal Blade, Angle Tip; (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable; (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable; (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable; (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm; (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm; (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable; (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable; (14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable; (18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable; (19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable; (20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable; (21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable; (22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable; (23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable; (24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.	There was an increase in complaints related to tip breaks and wobble/vibration.	Class II	2021-08-31	Open, Classified
Z-2673-2020	Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.	During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.	Class II	2020-06-12	Terminated
Z-0735-2020	Lamicel 10PK 10MM INTL	Routine sterilization dose does not meet the required Sterility Assurance Level.	Class II	2019-11-13	Open, Classified
Z-0734-2020	Lamicel 20PK 5MM INTL	Routine sterilization dose does not meet the required Sterility Assurance Level.	Class II	2019-11-13	Open, Classified
Z-0733-2020	Lamicel 20PK 3MM INTL Cervical dilator	Routine sterilization dose does not meet the required Sterility Assurance Level.	Class II	2019-11-13	Open, Classified
Z-0901-2017	NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.	Wire in tubing can become exposed, posing potential harm to the intubated patient.	Class II	2016-06-28	Terminated
Z-2284-2013	Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.	One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.	Class II	2013-08-23	Terminated
Z-1934-2013	Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.	The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"	Class II	2013-07-09	Terminated
Z-1420-2013	REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.	In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.	Class I	2013-03-04	Terminated
Z-1700-2011	Recall of Alcohol Pads contained in the following kits distributed by Medtronic: *REF 1529100Thermasplint Kit, SmallX5. REF 1529110Thermasplint Kit, MediumX5. REF 1529120Thermasplint Kit, LargeX5. RECALLED PRODUCT - Front: Allegiance Alcohol Prep PadAntiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only Cat. 40000-090NDC 63517-300-10Qty. 1 eaDistributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04Cardinal Health. RECALLED PRODUCT - Back: Drug FactsActive ingredient Isopropyl Alcohol, 70% v/v....Purpose AntisepticUse For preparation of skin prior to injectionWarnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Wipe injection site vigorously and discard.Inactive ingredient purified water.**	Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 1528126 (med), 1528136 (lg) and the Thermasplints REF 1529100 (sm), 1529110 (med), and 1529120 (lg) distributed from Jan 2008 through Aug 2010. The alcohol supplier, Cardinal Health, issued a recall on the alcohol pads on Jan		2011-02-21	Terminated
Z-1699-2011	An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. Recall of Alcohol Pads contained in the following kits distributed by Medtronic: *REF 1528116External Nasal Splint Kit, SmallX5. REF 1528126External Nasal Splint Kit, MediumX5. REF 1528136External Nasal Splint Kit, LargeX5. RECALLED PRODUCT - Front: Allegiance Alcohol Prep PadAntiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only Cat. 40000-090NDC 63517-300-10Qty. 1 eaDistributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04Cardinal Health. RECALLED PRODUCT - Back: Drug FactsActive ingredient Isopropyl Alcohol, 70% v/v....Purpose AntisepticUse For preparation of skin prior to injectionWarnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Wipe injection site vigorously and discard.Inactive ingredient purified water.** Each Kit Includes the dorsum pad (splint), an alcohol sponge (prep pad), skin preparation and skin closure tapes (steri-strips).	Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 1528126 (med), 1528136 (lg) and the Thermasplints REF 1529100 (sm), 1529110 (med), and 1529120 (lg) distributed from Jan 2008 through Aug 2010. The alcohol supplier, Cardinal Health, issued a recall on the alcohol pads on Jan		2011-02-21	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain