Pajunk GmbH

Country not established

Devices: 19
FDA recalls: 10 ongoing since 2021 (1 open in total); 1 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Pajunk GmbH makes

Pajunk GmbH manufactures medical instruments for minimally invasive procedures, including spinal and epidural needles (e.g., Tuohy, Quincke, Chiba, Crawford), cannulas, and modular valve handles for adaptable tubes. Their portfolio also covers trocar sleeves and accessories for surgical procedures, as well as specialized catheter sets like the Stimulong Plus and nanoline cannula systems. Safety-focused devices such as the EpiSpin series for epidural anesthesia are also produced, alongside modifications for existing set configurations.

The company’s products fall under FDA Class II medical devices and are listed in the FDA’s 510(k) clearance registry. These devices are regulated under U.S. medical device laws, ensuring compliance with performance and safety standards. The manufacturer operates with a U.S. presence, adhering to applicable regulatory requirements for Class II instruments.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue19

Newest first, rows 1-19 of 19

Search and filter all 19 devices

Chiba Sono Ref K113209

Active Regimes: 510(k) Registry: 510(k) Class:II
Trocar Sleeve And Accessories, Models 1287-Xx-Xx Ref K012771

Active Regimes: 510(k) Registry: 510(k) Class:II
Modular Valve Handles For Adaptable Tubes, Model 1298-Xx-Xx, 1295-Xx-Xx Ref K011997

Active Regimes: 510(k) Registry: 510(k) Class:II
Stimulong Plus Catheter Set Model, Various Ref K033018

Active Regimes: 510(k) Registry: 510(k) Class:II
Atraumatic Standard Sprotte Needle Ref K911202 Open recall

Active Regimes: 510(k) Registry: 510(k) Class:II
Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set Ref K053283

Active Regimes: 510(k) Registry: 510(k) Class:II
Modification To Plexolong Sets Ref K023218

Active Regimes: 510(k) Registry: 510(k) Class:II
Modification To: Plexalong Sets Ref K042979

Active Regimes: 510(k) Registry: 510(k) Class:II
Pajunk Modular Handle Instruments Ref K033249

Active Regimes: 510(k) Registry: 510(k) Class:II
Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles Ref K040965

Active Regimes: 510(k) Registry: 510(k) Class:II
Epispin, Epispin Ii Safety, Epispin Ii, Epispin I, Epispin Iv Ref K060563

Active Regimes: 510(k) Registry: 510(k) Class:II
Atraumatic Standard Sprotte Needle Ref K911260 Open recall

Active Regimes: 510(k) Registry: 510(k) Class:II
Plexolong Sets Ref K013041

Active Regimes: 510(k) Registry: 510(k) Class:II
Multistim Ref K011308

Active Regimes: 510(k) Registry: 510(k) Class:II
Atraumatic Special Sprotte Needle Ref K911221

Active Regimes: 510(k) Registry: 510(k) Class:II
Sono Tap, Tuohy Sono Ref K113207

Active Regimes: 510(k) Registry: 510(k) Class:II
Unipolar Needles Ref K000722

Active Regimes: 510(k) Registry: 510(k) Class:II
Modification To Pajunk Stimulong Plus Catheter Sets Ref K043130

Active Regimes: 510(k) Registry: 510(k) Class:II
Adaptable Monopolar Electrodes With Ceramic Tip Ref K053282

Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-19 of 19

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Pajunk GmbH, initiated on 2019-08-30. By recorded status: 1 ongoing. The reasons filed fall into these groups: sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 0
2018 0
2019 1
2020 0
2021 0
2022 0
2023 0
2024 0
2025 0
2026 0

2019
- 30 Aug 2019 Z-0234-2020 Class II Open since 2019 Problem with packaging sealing process which affects sterility. Distribution: Worldwide distributions - US Nationwide including the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI,…
  Full distribution text
  Worldwide distributions - US Nationwide including the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, RI, SC, TN, TX, WI, WY. Countries of Germany, Ellada / Greece, Canada, Italy, Lietuva / Lithuania/ Litauen, Australia, Luxembourg, Austria, Nederland / Netherlands, Belgium, Polska / Poland, Switzerland, Sverige / Sweden, Czech Republic, Slovenija / Slovenia, Danmark / Denmark, Kroatien/ Croatia, Espa¿a / Spain, Aserbeidschan/ Azerbaidzan, Suomi / Finland, Brunei, France, Russland/ Russia, Great Britain, Oman, Israel.
  Submission number: K911260

Frequently asked questions

How many devices does Pajunk GmbH have in the registry?

The registry currently lists 19 devices for Pajunk GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pajunk GmbH's devices?

Among its 19 most recently registered devices, Pajunk GmbH has devices listed in FDA 510(k) (19 devices).

What risk classes do Pajunk GmbH's devices fall under?

Among its 19 most recently registered devices, the classes recorded for Pajunk GmbH's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Pajunk GmbH?

FDA recall records list 1 recall initiated by Pajunk GmbH, the most recent initiated on 30 Aug 2019. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Pajunk GmbH in the registry?

The most recently registered devices listed for Pajunk GmbH include CHIBA SONO, TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX, MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX and STIMULONG PLUS CATHETER SET MODEL, VARIOUS.

Generated automatically from registry data and not verified by a human reviewer.

At a glance

Market reach

What Pajunk GmbH makes

Catalogue19

Chiba Sono Ref K113209

Trocar Sleeve And Accessories, Models 1287-Xx-Xx Ref K012771

Modular Valve Handles For Adaptable Tubes, Model 1298-Xx-Xx, 1295-Xx-Xx Ref K011997

Stimulong Plus Catheter Set Model, Various Ref K033018

Atraumatic Standard Sprotte Needle Ref K911202 Open recall

Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set Ref K053283

Modification To Plexolong Sets Ref K023218

Modification To: Plexalong Sets Ref K042979

Pajunk Modular Handle Instruments Ref K033249

Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles Ref K040965

Epispin, Epispin Ii Safety, Epispin Ii, Epispin I, Epispin Iv Ref K060563

Atraumatic Standard Sprotte Needle Ref K911260 Open recall

Plexolong Sets Ref K013041

Multistim Ref K011308

Atraumatic Special Sprotte Needle Ref K911221

Sono Tap, Tuohy Sono Ref K113207

Unipolar Needles Ref K000722

Modification To Pajunk Stimulong Plus Catheter Sets Ref K043130

Adaptable Monopolar Electrodes With Ceramic Tip Ref K053282

FDA recalls1

Recalls initiated per year

Frequently asked questions