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
ACCURO TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
AEA SRL
  SUBSTANTIALLY EQUIVALENT 1
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
AVITUS ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AZUR MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOVENTUS LLC
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 2
CONTROL MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
DLP MEDICAL PRODUCTS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  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 1
HWAJIN MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL MEDICAL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD
  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
LIFENET HEALTH
  SUBSTANTIALLY EQUIVALENT 1
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
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
ORBIT BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERFECT MEDICAL INDUSTRY (VN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
PROSIDYAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
REVITAL HEALTHCARE (EPZ) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 2
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
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
  SUBSTANTIALLY EQUIVALENT 2
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
2020 5330 5330
2021 5868 5871
2022 5233 5233
2023 5222 5222
2024 5125 5125
2025 657 657

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5810 5810
Device Contamination with Chemical or Other Material 3658 3658
Break 3029 3029
Patient Device Interaction Problem 2113 2113
Computer Software Problem 1430 1430
Volume Accuracy Problem 1389 1389
Device Markings/Labelling Problem 1300 1303
Failure to Deliver 1257 1257
Material Too Rigid or Stiff 908 908
Defective Component 855 855
Contamination 672 672
Packaging Problem 584 584
Defective Device 577 577
Crack 492 492
Fluid/Blood Leak 461 461
Detachment of Device or Device Component 410 410
Material Separation 368 368
Wireless Communication Problem 357 357
Physical Resistance/Sticking 311 311
Material Deformation 311 311
Appropriate Term/Code Not Available 304 304
Connection Problem 281 281
Mechanical Jam 280 280
Insufficient Information 276 276
Adverse Event Without Identified Device or Use Problem 239 239
Inaccurate Delivery 232 232
Insufficient Flow or Under Infusion 209 209
Missing Information 199 199
Complete Blockage 198 198
Delivered as Unsterile Product 193 193
Product Quality Problem 181 181
Material Puncture/Hole 173 173
Manufacturing, Packaging or Shipping Problem 153 153
Failure to Align 144 144
Mechanical Problem 138 138
Improper or Incorrect Procedure or Method 122 122
Battery Problem 115 115
Loose or Intermittent Connection 101 101
Illegible Information 100 100
Contamination /Decontamination Problem 97 97
Material Twisted/Bent 96 96
Material Protrusion/Extrusion 94 94
Dull, Blunt 84 84
Off-Label Use 81 81
Material Integrity Problem 78 78
Fracture 75 75
Difficult or Delayed Activation 66 66
Obstruction of Flow 55 55
Component Missing 54 54
No Flow 51 51

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18577 18580
No Consequences Or Impact To Patient 2332 2332
No Known Impact Or Consequence To Patient 1831 1831
Hyperglycemia 1518 1518
No Patient Involvement 1361 1361
Insufficient Information 1152 1152
Hypoglycemia 333 333
Needle Stick/Puncture 279 279
Foreign Body In Patient 103 103
Diabetic Ketoacidosis 103 103
Pain 102 102
Coma 85 85
Exposure to Body Fluids 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Chemical Exposure 28 28
Loss of consciousness 27 27
Hemorrhage/Bleeding 24 24
Laceration(s) 22 22
Low Blood Pressure/ Hypotension 20 20
No Code Available 20 20
No Information 19 19
Fatigue 19 19
Nausea 18 18
Device Embedded In Tissue or Plaque 17 17
Bruise/Contusion 17 17
Missed Dose 16 16
Fever 15 15
Hypersensitivity/Allergic reaction 14 14
Underdose 14 14
Vomiting 14 14
Injection Site Reaction 14 14
Unspecified Infection 12 12
Skin Inflammation/ Irritation 12 12
Discomfort 12 12
Bacterial Infection 10 10
Polydipsia 10 10
Overdose 9 9
Eye Injury 9 9
Dizziness 9 9
Headache 8 8
Skin Tears 8 8
Chills 8 8
Injury 8 8
Convulsion/Seizure 8 8
Malaise 8 8
Abdominal Pain 7 7
Air Embolism 7 7
Confusion/ Disorientation 7 7
Unspecified Tissue Injury 7 7
High Blood Pressure/ Hypertension 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Access Scientific LLC II May-14-2020
2 Allison Medical, Inc. II Dec-13-2022
3 Allison Medical, Inc. II Nov-18-2022
4 Arrow International Inc II Jan-24-2020
5 B. Braun Medical, Inc. II Sep-27-2023
6 Becton Dickinson & Company II Mar-10-2023
7 Becton Dickinson & Company II Feb-12-2021
8 Cardinal Health 200, LLC I Feb-02-2024
9 Cardinal Health 200, LLC I Oct-26-2023
10 Cardinal Health 200, LLC II Oct-13-2023
11 Cypress Medical Products LLC II Sep-16-2024
12 Cypress Medical Products LLC II Aug-29-2024
13 Fresenius Medical Care Holdings, Inc. I Oct-06-2023
14 ICU Medical, Inc. II Dec-23-2020
15 Jiangsu Shenli Medical Production Co., Ltd. II May-20-2024
16 LINEAGE BIOMEDICAL, INC III Aug-08-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
18 MEDLINE INDUSTRIES, LP - Northfield II May-31-2024
19 MEDLINE INDUSTRIES, LP - Northfield II May-31-2024
20 MICROVENTION INC. II Nov-04-2021
21 Mckesson Medical-Surgical Inc. Corporate Office II Jun-07-2024
22 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
23 Sol-Millennium Medical Inc. II Sep-06-2024
24 Stradis Healthcare II Jan-11-2023
25 Wolf, Henke Sass, Gmbh II Sep-27-2023
-
-