Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device condom, synthetic
Regulation Description Condom.
Product CodeMOL
Regulation Number 884.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
CHURCH & DWIGHT CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL PROTECTION CORP.
  SUBSTANTIALLY EQUIVALENT 2
OKAMOTO USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
RB HEALTH (US), LLC
  SUBSTANTIALLY EQUIVALENT 1
SURETEX LIMITED
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 2 2
2023 2 2
2024 2 2
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Material Integrity Problem 2 2
Patient Device Interaction Problem 2 2
Device Slipped 1 1
Device Markings/Labelling Problem 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Fungal Infection 2 2
Urinary Tract Infection 2 2
Emotional Changes 1 1
Muscle Weakness 1 1
Purulent Discharge 1 1
Itching Sensation 1 1
Localized Skin Lesion 1 1
Discomfort 1 1
Scar Tissue 1 1
Swelling/ Edema 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 1 1
Abortion 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
-
-