404 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IASH65A SHOULDER PACK IHUE40AI UPPER EXTREMITY PK| STRL F G ILTJ47AA TOTAL JOINT PACK LMHP14Z ORIF HIP, ST LUKES METHODIS LMSN44AE SPINAL PACK MHHP25H HAND PACK - 206002 MHTH90AJ TOTAL HIP PACK - 206016 MWAH32P ANTERIOR HIP PACK MWTK13AH TOTAL KNEE PLOR89H ORTHO MINOR PACK RCUE81B UPPER EXTREMITY RCH 0247031 TSTH54D TOTAL HIP TRAY UDEX85Y DSC EXTREMITY - 206050 UDHD69U HAND PACK - 206055 UDKN68AH CUSTOM KNEE - 206061 UIHN18AW ACS HAND PACK (PS 020640) UIHN18AX ACS HAND PACK (PS 020640) UIKN28AR ASC KNEE PACK (PS 020641) UISO44I SFCH SMALL ORTHO PACK (PS 143213)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PACK - 206005, MHRB88AO ROBOTIC PACK - 242561, RCLC51C LAP CHOLE RCH 0246969, SMLC53C LAP CHOLE PACK, UDLC17AE DSC LAP CHOLE PACK - 206062, UIRU84AE ROBOTIC UROLOGY PACK (PS 060571)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
FDA Enforcement
Class II
·Ongoing·CAREFUSION·September 22, 2021
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC DRAPE PACK (PS 907284) UIVA75I VASCULAR PACK
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML SYRINGE; Dover HYDROGEL COATED LATEX FOLEY TRAY 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover SILICONE COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover SILICONE COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover HYDROGEL COATED LATEX FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover 100% SILICONE FOLEY TRAY, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover URINE METER ADD-A-FOLEY TRAY, 400 ML, TOP VENT, LUER-LOCK SAMPLING, DRAIN SPOUT, PREP TRAY; Dover 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2-WAY, CATH SECUREMENT; Dover 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 14 FR (4.7 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY, 30 ML LUBE SYRINGE; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, 14 FR (4.7 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT ; Dover HYDROGEL COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML BAG; Dover 100% SILICONE 200 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLELESS SAMPLING, A/R CHAMBER, DRAIN SPOUT, PREP TRAY; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover 100% SILICONE SILVERHYDROGEL FOLEY TRAY; Dover Silicone 100% 16FR/18F; Dover 100% Silver Hydro tray
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 28, 2024
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL (PS 64405) UISH15AV SHUNT PACK (PS 039360)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2-WAY; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY INSERTION TRAY, 5 CC, PREP TRAY, 16 FR (5.3 MM); Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 18 FR (6.0 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover" HYDROGEL COATED COUD¿ TIP LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER-LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED COUD¿ TIP LATEX 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML BAG
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 28, 2024
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; 5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.
FDA Enforcement
Class II
·Ongoing·SunMed Holdings, LLC·November 29, 2023
BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006
FDA Enforcement
Class II
·Ongoing·CAREFUSION·September 22, 2021