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 needle, hypodermic, single lumen
Regulation Description Hypodermic single lumen needle.
Product CodeFMI
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
ACE MEDICAL INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ACTUATED MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALTAVIZ, LLC
  SUBSTANTIALLY EQUIVALENT 2
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
AZUR MEDICAL COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 4
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARRTECH CORP
  SUBSTANTIALLY EQUIVALENT 1
CC BIOTECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 1
CMT HEALTH PTE., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EINSTEIN WORKS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HH GLOBAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
HTL STREFA SA
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
NINGBO MEDSUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NOVO NORDISK, INC.
  SUBSTANTIALLY EQUIVALENT 2
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 3
OWEN MUMFORD, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE SPA
  SUBSTANTIALLY EQUIVALENT 2
PROMAMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
SANDSTONE MEDICAL (SUZHOU), INC.
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO EUROPE N.V.
  SUBSTANTIALLY EQUIVALENT 4
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TSK LABORATORY, JAPAN
  SUBSTANTIALLY EQUIVALENT 1
ULTIMED INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
VACUTEST KIMA SRL
  SUBSTANTIALLY EQUIVALENT 1
W. L. MED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WAISMED, LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEPON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG KINDLY MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZIEN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4532 4581
2022 4885 4940
2023 4986 5019
2024 4053 4059
2025 2464 2464
2026 396 396

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 4353 4359
Complete Blockage 2887 2887
Break 2410 2442
Leak/Splash 1551 1555
Device Contamination with Chemical or Other Material 1042 1043
Defective Device 686 700
Fluid/Blood Leak 678 687
Misconnection 600 600
Detachment of Device or Device Component 584 612
Defective Component 568 584
Device Markings/Labelling Problem 415 419
Difficult or Delayed Activation 410 410
Contamination 336 336
Product Quality Problem 303 308
Material Twisted/Bent 260 289
Component Missing 250 250
Material Protrusion/Extrusion 248 249
Material Separation 226 233
No Flow 224 224
Packaging Problem 221 225
Obstruction of Flow 219 221
Separation Problem 214 215
Physical Resistance/Sticking 175 179
Partial Blockage 162 162
Fail-Safe Problem 152 153
Failure to Cut 152 154
Adverse Event Without Identified Device or Use Problem 147 148
Off-Label Use 139 139
Delivered as Unsterile Product 137 137
Material Deformation 133 133
Crack 130 131
Failure to Prime 122 123
Difficult to Remove 118 118
Contamination /Decontamination Problem 117 117
Material Puncture/Hole 117 119
Dull, Blunt 117 144
Activation Problem 116 116
Malposition of Device 116 116
Connection Problem 97 98
Loose or Intermittent Connection 93 98
Missing Information 83 83
Retraction Problem 78 79
Fail-Safe Did Not Operate 73 100
Insufficient Information 69 69
Premature Activation 61 61
Incomplete or Inadequate Connection 60 60
Mechanical Problem 59 63
Disconnection 58 62
Manufacturing, Packaging or Shipping Problem 54 54
Complete Loss of Power 51 51

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18109 18167
Needle Stick/Puncture 958 988
Insufficient Information 880 902
No Consequences Or Impact To Patient 485 485
Foreign Body In Patient 381 389
Pain 231 237
Hyperglycemia 176 176
Exposure to Body Fluids 68 68
Device Embedded In Tissue or Plaque 62 64
Hemorrhage/Bleeding 62 62
Injection Site Reaction 50 50
Skin Inflammation/ Irritation 41 41
No Patient Involvement 40 40
Bruise/Contusion 37 38
Discomfort 37 38
Swelling/ Edema 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 50
Hypoglycemia 22 24
Hypersensitivity/Allergic reaction 16 16
Laceration(s) 15 19
Chemical Exposure 14 14
Bacterial Infection 13 13
Easy Bruising 13 13
Erythema 12 12
Skin Tears 12 12
Unspecified Tissue Injury 12 12
Anxiety 11 11
Subcutaneous Nodule 10 10
Hematoma 10 10
Fever 9 9
Dizziness 9 9
Diabetic Ketoacidosis 9 10
Itching Sensation 9 9
Rash 8 8
Irritation 8 8
Skin Infection 7 7
Abscess 6 6
Endophthalmitis 6 6
Extravasation 5 5
Inflammation 5 5
No Information 5 5
Cardiac Arrest 5 5
Immunodeficiency 5 5
Sepsis 4 4
Abrasion 3 3
Muscle Weakness 3 3
Local Reaction 3 3
Syncope/Fainting 3 3
Skin Discoloration 3 3
Fall 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Apellis Pharmaceuticals, Inc. II Sep-29-2023
2 Bard Access Systems, Inc. I Jul-22-2022
3 Bard Peripheral Vascular Inc II Oct-01-2021
4 Cardinal Health 200, LLC II Mar-15-2021
5 Cardinal Health Inc. II Jun-23-2021
6 Embecta Corp. II Jul-23-2024
7 Greiner Bio-One GmbH II Jan-03-2025
8 Owen Mumford USA, Inc. II Jul-15-2021
9 Retractable Technologies, Inc. II Mar-14-2024
10 Waismed Ltd. II Jul-17-2025
11 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
-
-