BEUDAMED
    44 results · 21ms · Sources: EU EUDAMED, US FDA

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    Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP

    FDA Enforcement
    Class II ·Ongoing·InfuTronix LLC·April 6, 2022

    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.

    FDA Enforcement
    Class I ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 16, 2025

    Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL. 6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL. 7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL. 8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. 9. SESK UAB SPINAL EPIDURAL. 10. SESK CREIGHTON UNIV BMH SOINAL EPIDURAL. 11. SESK, BSW SPINAL EPIDURAL TRAY. 12. LYNDON B JOHNSON HOSPITAL SPINAL EPID.

    FDA Enforcement
    Class II ·Ongoing·B BRAUN MEDICAL INC·October 15, 2025

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025

    CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·December 3, 2025

    Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018

    Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018

    3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.

    FDA Enforcement
    Class II ·Terminated·3M Company/3m Espe Dental Products·September 4, 2013

    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7051; SAFE-T-FILL Micro Capillary Blood Collection, 150 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7052; SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7053; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7056; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Flat Bottom Microtube, Purple, Model: 07 7058 SAFE-T-FILL¿ End-to-End Capillary Tubes, 30 ¿L; Plastic, Prepared with EDTA Dipotassium Model: 06 0910

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 5, 2025

    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025