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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilization wrap containers, trays, cassettes & other accessories
Product CodeKCT
Regulation Number 880.6850
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 4
ANTHOGYR
  SUBSTANTIALLY EQUIVALENT 2
AVALIGN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVINENT IMPLANT SYSTEM S.L.U.
  SUBSTANTIALLY EQUIVALENT 1
AVINENT IMPLANT SYSTEM, S.L.U.
  SUBSTANTIALLY EQUIVALENT 1
AYGUN SURGICAL INSTRUMENTS CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BEGO IMPLANT SYSTEMS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BIOTECH DENTAL, SAS
  SUBSTANTIALLY EQUIVALENT 1
CALDERA MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
CASE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
CASE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
COCHLEAR
  SUBSTANTIALLY EQUIVALENT 1
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 2
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.
  SUBSTANTIALLY EQUIVALENT 7
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.
  SUBSTANTIALLY EQUIVALENT 2
K1 MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 4
KARL STORZ ENDOSCOPY AMERICA INC
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPYAMERICA INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 3
NOBEL BIOCARE SERVICES AG
  SUBSTANTIALLY EQUIVALENT 2
O&M HALYARD, INC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 2
OSTEOMED LLC
  SUBSTANTIALLY EQUIVALENT 2
PARAGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PMBS, LLC
  SUBSTANTIALLY EQUIVALENT 1
RP MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
S.I.N. – SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
SOADCO, S.L.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN IMPLANTS (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
STERICUBE, LLC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
STERIZIGN PRECISION TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRAUMANN USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMITT MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
SWEDEN & MARTINA S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS LLC / DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
Z-SYSTEMS AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 22 22
2019 15 15
2020 66 66
2021 26 26
2022 8 8
2023 30 30
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 70 70
Material Puncture/Hole 25 25
Crack 12 12
Contamination /Decontamination Problem 7 7
Device Markings/Labelling Problem 5 5
Material Discolored 5 5
Improper Chemical Reaction 4 4
Defective Component 4 4
Failure to Align 4 4
Material Split, Cut or Torn 4 4
Unexpected Color 4 4
Problem with Sterilization 3 3
Device Contamination with Chemical or Other Material 3 3
Peeled/Delaminated 2 2
Material Perforation 2 2
Device Damaged Prior to Use 2 2
Defective Device 2 2
Residue After Decontamination 2 2
Break 2 2
Contamination 2 2
Corroded 2 2
Smoking 2 2
Fracture 2 2
Material Fragmentation 2 2
Hole In Material 2 2
Labelling, Instructions for Use or Training Problem 2 2
Loose or Intermittent Connection 2 2
Material Deformation 2 2
Appropriate Term/Code Not Available 2 2
Sharp Edges 1 1
Device Fell 1 1
Inaccurate Information 1 1
Osseointegration Problem 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Delivered as Unsterile Product 1 1
Degraded 1 1
Thermal Decomposition of Device 1 1
Material Erosion 1 1
Fire 1 1
Flaked 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Contaminated During Manufacture or Shipping 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Difficult to Open or Close 1 1
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 69
No Known Impact Or Consequence To Patient 59 59
No Patient Involvement 29 29
No Consequences Or Impact To Patient 5 5
Failure of Implant 5 5
Insufficient Information 4 4
No Code Available 2 2
Laceration(s) 2 2
Pain 1 1
Inflammation 1 1
Chemical Exposure 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Feb-15-2018
2 Carefusion 2200 Inc II Mar-09-2023
3 Carefusion 2200 Inc II Nov-11-2022
4 Intuitive Surgical, Inc. II Jun-09-2020
5 Karl Storz Endoscopy II Jun-21-2023
6 Karl Storz Endoscopy II Jun-21-2023
7 Karl Storz Endoscopy II Dec-29-2021
8 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
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