DeRoyal Industries, Inc.
Maynardville, TN, US
DEROYAL INDUSTRIES, INC. appears in FDA device records in Maynardville, TN. FDA records list 92 510(k) clearances between and , no PMA records and 9 registered establishments. As of , FDA records show 239 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to DeRoyal Industries, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- DeRoyal Processing Centerrecall
- DeRoyal Surgical Trayrecall
- DeRoyal Technologies Increcall
510(k) clearance history
Showing 50 of 92FDA records hold 92 510(k) clearances for DeRoyal Industries, Inc. between 1984 and 2025. The busiest year on record is 1994, with 11. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 6 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 1 |
| 1990 | 3 |
| 1991 | 7 |
| 1992 | 6 |
| 1993 | 2 |
| 1994 | 11 |
| 1995 | 7 |
| 1996 | 11 |
| 1997 | 10 |
| 1998 | 4 |
| 1999 | 1 |
| 2003 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 5 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | OMP | Substantially Equivalent | |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K200631 | DeRoyal Temperature Monitoring Probe | FLL | Substantially Equivalent | |
| K200757 | Foley Catheter with Temperature Sensor | EYC | Substantially Equivalent | |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable | FMT | Substantially Equivalent | |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French | BZT | Substantially Equivalent | |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover | FMT | Substantially Equivalent | |
| K173072 | Algidex Ag Silver Alginate Wound Dressing | FRO | Substantially Equivalent | |
| K171475 | DeRoyal Laprador Specimen Retrieval System | GCJ | Substantially Equivalent | |
| K152978 | DeRoyal Angiography Kits | DXT | Unknown | |
| K142962 | PROTOCOL Incision Dressing | FRO | Substantially Equivalent | |
| K131292 | DEROYAL SPINE SPACER SYSTEM | MAX | Substantially Equivalent | |
| K132199 | DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST | GEI | Substantially Equivalent | |
| K090975 | DEROYAL NON-LOCKING BONE FIXATION SYSTEM | HRS | Substantially Equivalent | |
| K092317 | DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM | HRS | Substantially Equivalent | |
| K023591 | ULTRA HIGH PRESSURE INJECTOR LINES | DQO | Substantially Equivalent | |
| K030365 | DEROYAL DRAPES, STERILE, NON-STERILE | KKX | Substantially Equivalent | |
| K030364 | DEROYAL GOWNS, STERILE, NON-STERILE | FYA | Substantially Equivalent | |
| K991525 | DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | |
| K983750 | DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER | FMI | Substantially Equivalent | |
| K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER | OCT | Substantially Equivalent | |
| K974763 | DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA | HET | Substantially Equivalent | |
| K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | IMD | Substantially Equivalent | |
| K972693 | DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR | HOZ | Substantially Equivalent | |
| K970993 | DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE | GEI | Substantially Equivalent | |
| K963466 | PEDIATRIC LIMB HOLDER | FMQ | Substantially Equivalent | |
| K963479 | WHEELCHAIR BELT | KID | Substantially Equivalent | |
| K963480 | MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER | KID | Substantially Equivalent | |
| K963476 | DISPOSABLE LIMB HOLDER | FMQ | Substantially Equivalent | |
| K963475 | PONCHO VEST RESTRAINT | KID | Substantially Equivalent | |
| K963474 | TUXEDO VEST RESTRAINT | FMQ | Substantially Equivalent | |
| K963468 | RESTRICTIVE LIMB HOLDER | FMQ | Substantially Equivalent | |
| K963467 | ROLL BELTS | FMQ | Substantially Equivalent | |
| K963465 | PELVIC HOLDER | FMQ | Substantially Equivalent | |
| K963478 | SLEEVED/SLEEVELESS VEST RESTRAINT | FMQ | Substantially Equivalent | |
| K963473 | REUSABLE LIMB HOLDER | FMQ | Substantially Equivalent | |
| K963472 | PEDIATRIC VEST RESTRAINT | FMQ | Substantially Equivalent | |
| K963471 | SUPER SECURITY RESTRAINT | FMQ | Substantially Equivalent | |
| K963470 | CRISS-CROSS VEST RESTRAINT | FMQ | Substantially Equivalent | |
| K963469 | MITTENS | FMQ | Substantially Equivalent | |
| K963477 | PEDIATRIC MITTENS | FMQ | Substantially Equivalent | |
| K963464 | RESTRAINT NET | FMQ | Substantially Equivalent | |
| K963463 | STRAIT JACKET | FMQ | Substantially Equivalent | |
| K961647 | DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL | GEI | Substantially Equivalent | |
| K950565 | DEROYAL SURGICAL INSTRUMENT DRAPE | KKX | Substantially Equivalent | |
| K953403 | DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS | KMF | Substantially Equivalent for Some Indications | |
| K952775 | DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING | MGQ | Substantially Equivalent for Some Indications | |
| K953953 | DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF | KCY | Substantially Equivalent | |
| K953952 | DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | |
| K951178 | UROLOGICAL CATHETER & ACCESSORIES | FCM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1034876 | 1034876 | DEROYAL INDUSTRIES, INC. | 185 RICHARDSON WAY, MAYNARDVILLE, TN 37807 US | 2026 | and 15 more, listed in full below |
| 1043214 | 1043214 | DEROYAL INDUSTRIES, INC. | 200 DEBUSK LN., POWELL, TN 37849 US | 2026 | and 347 more, listed in full below |
| 1051550 | 1051550 | DEROYAL INDUSTRIES, INC. | 165 RICHARDSON WAY, MAYNARDVILLE, TN 37807 US | 2026 | |
| 1055236 | 1000112968 | DEROYAL INDUSTRIES, INC. | 1211 HWY. 33 SOUTH, NEW TAZEWELL, TN 37825 US | 2026 | and 255 more, listed in full below |
| 2320762 | 3003040625 | DEROYAL INDUSTRIES, INC. | 1595 Highway 33 S, NEW TAZEWELL, TN 37825 US | 2026 | and 194 more, listed in full below |
| 1054241 | 1000112877 | DeRoyal Industries, Inc. | 1135 HWY. 33 SOUTH, NEW TAZEWELL, TN 37825 US | 2026 | and 259 more, listed in full below |
| 1057404 | 1000208576 | DeRoyal Industries, Inc. | 300 DEBUSK LN., POWELL, TN 37849 US | 2026 | and 6 more, listed in full below |
| 1060680 | 1000208624 | DeRoyal Industries, Inc. | 1703 Highway 33 S, NEW TAZEWELL, TN 37825 US | 2026 | and 124 more, listed in full below |
| 3008583452 | 3008583452 | DeRoyal Industries, Inc. | 213 DeBusk Lane, Powell, TN 37849 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CAZAnesthesia Conduction Kit
- BTCBag, Reservoir
- EMXBalloon, Epistaxis
- DWHBlade, Saw, Surgical, Cardiovascular
- DXQBlood Pressure Cuff
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- BSOCatheter, Conduction, Anesthetic
- EZCCatheter, Coude
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- EZLCatheter, Retention Type, Balloon
- EZDCatheter, Straight
- EYCCatheter, Upper Urinary Tract
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- DXCClamp, Vascular
- DSSClip, Vascular
- EFNCotton, Roll
- CBHDevice, Fixation, Tracheal Tube
- DREDilator, Vessel, For Percutaneous Catheterization
- DWPDilator, Vessel, Surgical
- DRXElectrode, Electrocardiograph
- BXBExerciser, Powered
- CAHFilter, Bacterial, Breathing-Circuit
- EYQGarment, Protective, For Incontinence
- EFQGauze/Sponge, Internal
- EMDHemostat, Surgical
- DXTInjector And Syringe, Angiographic
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- FDELaparoscopy Kit
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- DRIMonitor, Line Isolation
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- BTAPump, Portable, Aspiration (Manual Or Powered)
- FAMSigmoidoscope And Accessories, Flexible/Rigid
- BZTStethoscope, Esophageal, With Electrical Conductors
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass
- CCXSupport, Patient Position
- EICSyringe, Periodontic, Endodontic, Irrigating
- DWJSystem, Thermal Regulating
- EYHTable, Cysto, Non-Electrical
- EFWToothbrush, Manual
- DRSTransducer, Blood-Pressure, Extravascular
- DXOTransducer, Pressure, Catheter Tip
- BYZTrap, Sterile Specimen
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- EXMTruss, Umbilical
- BYYTube, Aspirating, Flexible, Connecting
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation
- BYXTubing, Pressure And Accessories
- DWETubing, Pump, Cardiopulmonary Bypass
- EBRUnit, Suction Operatory
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 239| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2305-2026 | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm) | Sterile wound dressing, lacks sterility assurance | Class II | Open, Classified | |
| Z-1291-2025 | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement | Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care. | Class II | Open, Classified | |
| Z-1174-2025 | DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement | The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care. | Class II | Open, Classified | |
| Z-0309-2025 | DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released. | Class II | Open, Classified | |
| Z-0308-2025 | DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released. | Class II | Open, Classified | |
| Z-0307-2025 | DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released. | Class II | Open, Classified | |
| Z-0306-2025 | DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released. | Class II | Open, Classified | |
| Z-1382-2024 | GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART | DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled. | Class I | Open, Classified | |
| Z-0622-2024 | DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 | Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences. | Class II | Open, Classified | |
| Z-0116-2024 | DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit | DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe. | Class II | Open, Classified | |
| Z-2090-2023 | Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183 | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | Class II | Open, Classified | |
| Z-2089-2023 | Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219 | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | Class II | Open, Classified | |
| Z-2088-2023 | Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478 | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | Class II | Open, Classified | |
| Z-2087-2023 | Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014 | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | Class II | Open, Classified | |
| Z-2086-2023 | Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK, REF '89-7540; n) EPIDURAL TRAY/CUSTOM, REF '89-8061; o) BREAST BIOPSY TRAY, REF '89-8187; p) BEACH CHAIR PACK, REF '89-8439; q) TOTAL KNEE PACK PGYBK, REF '89-8445; r) CYSTO PACK, REF '89-8482; s) SINGLE BASIN PLUS, REF '89-9131; t) TOTAL HIP PACK, REF '89-9287; u) ARTHROSCOPY PACK, REF '89-9626; v) SHOULDER PACK, REF '89-9632 CYSTO PACK, REF '89-10049 BEACH CHAIR SHOULDER PACK, REF '89-10721 EXTREMITY PACK, REF '89-10959 HYSTEROSCOPY PACK, REF '89-10960 VERITHENA VENOUS ABLATION PACK, REF '89-10977 CYSTO BASIN SET, REF '89-2577 OPEN HEART PACK, REF '89-8572 BACK PACK, REF '89-9292 | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | Class II | Open, Classified | |
| Z-1692-2023 | Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital. | The custom procedure packs contain light handle covers that have been recalled by another firm. | Class II | Open, Classified | |
| Z-1691-2023 | Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp; (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital; (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital; (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital; (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital; (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital; (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (17) 89-10560.03, CMC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (18) 89-10561.02, CMC LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (19) 89-10562.02, CMC MINOR ENT/PLASTIC PACK, Carilion Roanoke Memorial Hospital; (20) 89-10564.02, CMC MAJOR PLASTIC PACK, Carilion Roanoke Memorial Hospital; (21) 89-10569.02, CMC PEDIATRIC PACK, Carilion Roanoke Memorial Hospital; (22) 89-10570.02, CMC POSTERIOR SPINE PACK, Carilion Roanoke Memorial Hospital; (23) 89-10574.02, CMC SHOULDER ARTHROSCOPY PACK, Carilion Roanoke Memorial Hospital; (24) 89-10575.02, OWEN HIP PACK, Carilion Roanoke Memorial Hosp; (25) 89-10576.03, THORACOSCOPY / THORACOTOMY, Carilion Roanoke Memorial Hosp; (26) 89-10580.03, VALVE REPLACEMENT PACK PGYBK, Carilion Roanoke Memorial Hosp. | The custom procedure packs contain light handle covers that have been recalled by another firm. | Class II | Open, Classified | |
| Z-1283-2023 | DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B | The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum. | Class II | Open, Classified | |
| Z-0927-2023 | DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach. | Class II | Terminated | |
| Z-0906-2023 | DeRoyal Tonsillectomy Tray, REF 89-10698.01 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use. | Class II | Terminated | |
| Z-0715-2023 | DeRoyal CATARACT PACK, REF 89-10086.05 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | Class II | Open, Classified | |
| Z-0714-2023 | DeRoyal CATARACT PACK, REF 89-10040.01 | XXX | Class II | Open, Classified | |
| Z-0713-2023 | DeRoyal CATARACT PACK, REF 89-9241.04 | XXX | Class II | Open, Classified | |
| Z-0712-2023 | DeRoyal CATARACT PACK, REF 89-9241.03 | XXX | Class II | Open, Classified | |
| Z-0711-2023 | DeRoyal CATARACT PACK, REF 89-8859.08 | XXX | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain