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8,939 catalysts · 3,229 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 584 earnings
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8,939 catalysts · 3,229 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 584 earnings
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10. — Reason: Tablets/Capsules Imprinted with Wrong ID — Status: Ongoing
Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. — Reason: Defective Delivery System: Missing or duplicated needles within the injection kit — Status: Ongoing
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11 — Reason: cGMP deviations — Status: Ongoing
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32 — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: NBC. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: MEG. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OWE. Advisory committee: PA. Decision: OK30
Supplement type: Real-Time Process. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: SFJ. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: SDQ. Advisory committee: GU. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: PNK. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Advisory committee: PA. Decision: OK30
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. — Reason: Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. — Status: Ongoing
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc, — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target. — Reason: Due to adapter not being properly aligned or locked in place. — Status: Ongoing
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc) — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014). — Reason: Increased risk of purge leaks with Generation 1 purge cassettes. — Status: Ongoing
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Cub Pediatric Crib, Model FL19H — Reason: Cribs sold in the USA are missing two access door warning labels. — Status: Ongoing