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 syringe, piston
Regulation Description Piston syringe.
Product CodeFMF
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
AVITUS ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AZUR MEDICAL COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 4
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
BIMED TEKNIK ALETLER SANAYI & TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
BIOVENTUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDINALHEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARE FUSION
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 2
CHIRANA T.INJECTA,A.S.
  SUBSTANTIALLY EQUIVALENT 1
CMT HEALTH PTE., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DLP MEDICAL PRODUCTS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
DUOPROSS MEDITECH CORPORATE
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL, CO.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GO-PEN APS
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG ANTMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUIDESTAR MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HLB LIFESCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HWAJIN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JICHUN MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU KANGYOU MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SUYUN MEDICAL MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU ZHIYU MEDICAL INSTRUMENT CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI MAIDIKANG MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFELONG MEDITECH PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
LINEAGE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MD3, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDONE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDWELL TECHNOLOGY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MILESTONE SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANUM COMPANY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMEQ MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
PERFECT MEDICAL INDUSTRY (VN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
PROSIDYAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
REVITAL HEALTHCARE (EPZ) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG QINKAI MEDICAL INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMB CORPORATION OF INDIA
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPM MEDICARE PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI SHENGJIE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEPON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI NEST BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 5874 5901
2022 5233 5240
2023 5214 5220
2024 5122 5138
2025 4246 4246
2026 1676 1676

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 3726 3734
Device Contamination with Chemical or Other Material 3001 3002
Patient Device Interaction Problem 2821 2821
Break 2776 2784
Computer Software Problem 1418 1419
Contamination 1182 1187
Device Markings/Labelling Problem 1053 1058
Volume Accuracy Problem 1049 1050
Defective Component 1001 1002
Failure to Deliver 947 947
Material Too Rigid or Stiff 908 908
Physical Resistance/Sticking 822 823
Crack 584 585
Data Problem 534 534
Material Integrity Problem 523 524
Connection Problem 492 497
Defective Device 490 492
Fluid/Blood Leak 452 457
Contamination /Decontamination Problem 447 449
Detachment of Device or Device Component 427 430
Packaging Problem 426 426
Wireless Communication Problem 405 406
Material Separation 378 378
Appropriate Term/Code Not Available 365 367
Inaccurate Delivery 342 342
Insufficient Flow or Under Infusion 336 336
Material Deformation 315 316
Mechanical Jam 306 307
Insufficient Information 292 292
Adverse Event Without Identified Device or Use Problem 260 262
Manufacturing, Packaging or Shipping Problem 244 248
Product Quality Problem 220 222
Missing Information 197 197
Failure to Align 184 184
Improper or Incorrect Procedure or Method 165 165
Complete Blockage 159 159
Battery Problem 152 153
Off-Label Use 148 148
Delivered as Unsterile Product 148 148
Material Puncture/Hole 144 144
Mechanical Problem 133 134
Loose or Intermittent Connection 124 124
Material Twisted/Bent 112 114
Infusion or Flow Problem 110 110
Dull, Blunt 91 91
Excess Flow or Over-Infusion 84 84
Illegible Information 71 71
Fracture 71 71
Material Protrusion/Extrusion 62 62
Device Handling Problem 61 61

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22762 22790
Hyperglycemia 1899 1899
Insufficient Information 1226 1243
No Consequences Or Impact To Patient 628 628
Hypoglycemia 417 417
Needle Stick/Puncture 273 274
Diabetic Ketoacidosis 129 129
Foreign Body In Patient 112 112
Coma 92 92
No Patient Involvement 90 90
Pain 90 90
Exposure to Body Fluids 41 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 46
Loss of consciousness 31 31
Chemical Exposure 26 26
Nausea 26 26
Fatigue 25 25
Laceration(s) 24 25
Hemorrhage/Bleeding 24 24
Injection Site Reaction 19 19
Unspecified Infection 18 18
Skin Inflammation/ Irritation 17 17
Polydipsia 16 16
Fever 15 15
Bruise/Contusion 14 14
Vomiting 14 14
Discomfort 14 14
Malaise 13 13
Headache 12 12
Low Blood Pressure/ Hypotension 11 11
Device Embedded In Tissue or Plaque 11 11
Hypersensitivity/Allergic reaction 10 10
Bacterial Infection 10 11
Syncope/Fainting 10 10
Eye Injury 10 10
Urinary Frequency 9 9
Skin Tears 9 9
Chills 8 8
Dehydration 8 8
Dizziness 8 8
Convulsion/Seizure 8 8
Abdominal Pain 8 8
Unspecified Tissue Injury 8 8
Confusion/ Disorientation 7 7
Myocardial Infarction 7 7
Speech Disorder 6 6
Air Embolism 6 6
Swelling/ Edema 6 6
Fall 5 5
Dyspnea 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Allison Medical, Inc. II Dec-13-2022
2 Allison Medical, Inc. II Nov-18-2022
3 B. Braun Medical, Inc. II Sep-27-2023
4 BD SWITZERLAND SARL II Jun-12-2025
5 Becton Dickinson & Company II Mar-06-2026
6 Becton Dickinson & Company II Mar-10-2023
7 Becton Dickinson & Company II Feb-12-2021
8 Cardinal Health 200, LLC II Apr-02-2026
9 Cardinal Health 200, LLC I Feb-02-2024
10 Cardinal Health 200, LLC I Oct-26-2023
11 Cardinal Health 200, LLC II Oct-13-2023
12 Cypress Medical Products LLC II Sep-16-2024
13 Cypress Medical Products LLC II Aug-29-2024
14 Fresenius Medical Care Holdings, Inc. I Oct-06-2023
15 Integra LifeSciences Corp. (NeuroSciences) I Jun-20-2025
16 Integra LifeSciences Corp. (NeuroSciences) I Jun-20-2025
17 Jiangsu Shenli Medical Production Co., Ltd. II May-20-2024
18 LINEAGE BIOMEDICAL, INC III Aug-08-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
20 MEDLINE INDUSTRIES, LP - Northfield II May-31-2024
21 MEDLINE INDUSTRIES, LP - Northfield II May-31-2024
22 MICROVENTION INC. II Nov-04-2021
23 Mckesson Medical-Surgical Inc. Corporate Office II Jun-07-2024
24 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
25 Medtronic MiniMed, Inc. II Apr-21-2025
26 Sol-Millennium Medical Inc. II Sep-06-2024
27 Stradis Healthcare II Jan-11-2023
28 Wolf, Henke Sass, Gmbh II Sep-27-2023
-
-