calendar
18,072 catalysts · 4,728 grant · 3,404 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
next 91 dayslessmore
MonWedFri
18,072 catalysts · 4,728 grant · 3,404 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION
Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL
Sponsor: GRANULES. Form: TABLET. Route: ORAL
Sponsor: CARWIN PHARM ASSOC. Form: SOLUTION/DROPS. Route: OTIC
Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION
Sponsor: BIOCON PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: BIOCON PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: KARYOPHARM THERAPS. Form: TABLET. Route: ORAL
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INHALATION, ORAL
Sponsor: ENCUBE. Form: GEL. Route: TOPICAL
Sponsor: DR REDDYS LABS SA. Form: TABLET. Route: ORAL
Product code: BWH. Advisory committee: Ear, Nose, Throat. Type: Special
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: HCG. Advisory committee: Neurology. Type: Special
Product code: FDA. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DXG. Advisory committee: Cardiovascular. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: OCX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PNL. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: SFV. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SCR. Advisory committee: Ear, Nose, Throat. Type: Traditional
Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30
Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: PJQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: Real-Time Process. Product code: PMP. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NXW. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
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. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
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 — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3/19/26 updated to add B105P Patient Monitor 6160001-061 B125P Patient Monitor 6160001-062 B105M-C Patient Monitor 6160002-033 B105M-A Patient Monitor 6160000-113 B155M-A Patient Monitor 6160000-115 B125P-B Patient Monitor 6160002-022 B105M-B Patient Monitor 6160002-023 B125M-B Patient Monitor 6160002-024 B105M-OR Patient Monitor 6160000-143 B105M-OR Patient Monitor 6160000-144 B155M-OR Patient Monitor 6160000-145 — Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment. — Status: Ongoing
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001 — Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment. — Status: Ongoing
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
CODMAN Disposable Perforator 11mm. Cranial Perforator. — Reason: Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution. — Status: Ongoing
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
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. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105 502-106 - Calf Implant style 1 size 6 UDI-DI code: B490502106 502-201 - Calf Implant style 2 size 1 UDI-DI code: B490502201 502-303 - Calf Implant style 3 size 3 UDI-DI code: B490502303 502-304 - Calf Implant style 3 size 4 UDI-DI code: B490502304 — Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis — Reason: Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa. — Status: Ongoing