Deroyal Industries, Inc.
Deroyal Industries, Inc. holds FDA 510(k) medical device clearances, first cleared 1984, most recent 2025, with 226 FDA device recalls on record.
Top product codes for Deroyal Industries, Inc.
FDA recalls by Deroyal Industries, Inc.
10 most recent of 226- Z-2305-2026 — DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
- 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
- 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
- Z-0307-2025 — DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
- Z-0309-2025 — DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
- Z-0306-2025 — DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
- Z-0308-2025 — DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
- Z-1382-2024 — GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
- Z-0622-2024 — DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
- Z-0116-2024 — DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Deroyal Industries, Inc.
- K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
- K230233 — Prospera Spectruum Negative Pressure Wound Therapy System
- K200631 — DeRoyal Temperature Monitoring Probe
- K200757 — Foley Catheter with Temperature Sensor
- K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
- K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
- K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover
- K173072 — Algidex Ag Silver Alginate Wound Dressing
- K171475 — DeRoyal Laprador Specimen Retrieval System
- K152978 — DeRoyal Angiography Kits
- K131292 — DEROYAL SPINE SPACER SYSTEM
- K132199 — DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST
- K090975 — DEROYAL NON-LOCKING BONE FIXATION SYSTEM
- K092317 — DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM
- K023591 — ULTRA HIGH PRESSURE INJECTOR LINES
- K030365 — DEROYAL DRAPES, STERILE, NON-STERILE
- K030364 — DEROYAL GOWNS, STERILE, NON-STERILE
- K991525 — DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
- K983750 — DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
- K982465 — DEROYAL INDUSTRIES, INC. DEFOGGER
- K974763 — DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
- K980509 — DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
- K972693 — DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
- K970993 — DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE
- K963466 — PEDIATRIC LIMB HOLDER
- K963479 — WHEELCHAIR BELT
- K963468 — RESTRICTIVE LIMB HOLDER
- K963474 — TUXEDO VEST RESTRAINT
- K963475 — PONCHO VEST RESTRAINT
- K963476 — DISPOSABLE LIMB HOLDER
- K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
- K963467 — ROLL BELTS
- K963465 — PELVIC HOLDER
- K963469 — MITTENS
- K963470 — CRISS-CROSS VEST RESTRAINT
- K963471 — SUPER SECURITY RESTRAINT
- K963472 — PEDIATRIC VEST RESTRAINT
- K963473 — REUSABLE LIMB HOLDER
- K963478 — SLEEVED/SLEEVELESS VEST RESTRAINT
- K963464 — RESTRAINT NET
- K963477 — PEDIATRIC MITTENS
- K963463 — STRAIT JACKET
- K961647 — DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL
- K950565 — DEROYAL SURGICAL INSTRUMENT DRAPE
- K952775 — DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING
- K953403 — DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS
- K953953 — DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
- K953952 — DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
- K951178 — UROLOGICAL CATHETER & ACCESSORIES
- K945789 — DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER
- K935985 — DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION
- K944435 — DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER
- K940169 — DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE
- K942879 — DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH
- K941390 — DISPOSABLE ASPIRATION/IRRIGATION TRUMPET VALVE PROBE
- K925792 — EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
- K934188 — DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART
- K934131 — DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING
- K925791 — EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR
- K935725 — EPISEAL ADHESIVE WOUND CLOSURE STRIPS
- K925006 — HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
- K925789 — DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
- K925790 — EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S
- K923300 — DEROYAL EYE DRESSING
- K921350 — QUALTEX TUBE/CORD ORGANIZER
- K920796 — DEROYAL TRANSPARENT FILM DRESSIGN
- K921349 — STERILE,DISPOSABLE EYE DRESSING
- K915182 — DEROYAL HYDROGEL DRESSING
- K913486 — QUALTEX SURGICAL DRAPE, MODIFICATION
- K914369 — QUALTEX MAGNETIC INSTRUMENT DRAPE
- K912472 — DEROYAL WOUND DRESSING
- K910657 — QUALTEX ISLAND DRESSING
- K911369 — QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER
- K911204 — QUALTEX SKIN STAPLE EXTRACTOR
- K911895 — QUALTEX SUTURE BOOTIES
- K910495 — QUALTEX SURGICAL DRAPE
- K904960 — QUALTEX SURGICAL DRAPE
- K903947 — QUALTEX NEEDLE COUNTERS
- K895427 — MEDISEAL SUCTION CANISTER
- K884790 — QUALTEX NEUROLOK SURGICAL SPONGE
- K864388 — MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY
- K861969 — STERILE TOWEL W/ANTIMICROBIAL AGENT
- K861196 — STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
- K860326 — TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT
- K842647 — CATARACT TRAY
- K842644 — TPN/HYPERALIMENTATION TRAY
- K842626 — HIP PROSTHESIS PACK
- K842627 — C-SECTION TRAY
- K842625 — CUSTOM NEURO TRAY
- K842648 — GENERAL SURGERY TRAY
- K842645 — CARDIAC SUPPLY TRAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.