Panels › Orthopedic › Product code NBH · Class 1
Accessories, Arthroscopic
Regulation 888.1100
0510(k)s in 12 months (2 all time)
0recalls in 12 months (55 all time)
17recalls that name a 510(k)
Top companies in NBH
| Company | 510(k)s | Recalls |
|---|---|---|
| BioPro, Inc. | 0 | 21 |
| Smith & Nephew, Inc Endoscopy Division | 0 | 18 |
| Smith & Nephew, Inc., Endoscopy Div. | 0 | 5 |
| Smith & Nephew, Inc. | 0 | 3 |
| Ceterix Orthopedics, Inc. | 0 | 2 |
| Bio-Blitz, Inc. | 1 | 0 |
| DePuy Mitek, Inc., a Johnson & Johnson Co. | 0 | 1 |
| Instratek, Incorporated | 0 | 1 |
| Integra LifeSciences Corp. | 0 | 1 |
| Stryker Corporation | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2020 | Smith & Nephew, Inc. 5.5MM Arthrogarde Hip Access Cannula Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not Terminated |
NBH | K101030 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not int Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not int Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not int Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inten Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not int Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but Terminated |
NBH | K081149 |
| Jun 25, 2019 | BioPro, Inc. K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | K101030 |
| May 16, 2018 | Ceterix Orthopedics, Inc. Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory. Terminated |
NBH | None listed |
| Jun 15, 2016 | Smith & Nephew, Inc. Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use. Terminated |
NBH | None listed |
| Jun 3, 2016 | Stryker Corporation Stryker FlowPort II Adapter: Model number: 00CAT00778
The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures. Terminated |
NBH | None listed |
| Jan 29, 2016 | Smith & Nephew, Inc., Endoscopy Div. Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument Terminated |
NBH | None listed |
| Jan 11, 2016 | Smith & Nephew, Inc. Smith & Nephew BEAVER Blade 4.0mm
Part Number: 72203307
Orthopedic surgical instrument used in hip arthroscopy. Terminated |
NBH | None listed |
| Nov 9, 2015 | Ceterix Orthopedics, Inc. NovoCut Suture Manager; Ceterix catalog number CTX-001.
General and Plastic Surgery: Intended for use in arthroscopic surgery. Terminated |
NBH | None listed |
| Jul 30, 2013 | Smith & Nephew, Inc., Endoscopy Div. High Flow Irrigation Extender; Part Number 72201021.
Arthroscopic accessories are indicated for use in access of the joint capsule. Terminated |
NBH | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609
- CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. Terminated |
NBH | K012667 |
| May 9, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek Tissue Liberator -Blade Up
Catalog Number: 214623
The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except Terminated |
NBH | None listed |
| Mar 8, 2013 | Instratek, Incorporated Endotrig Trigger Release Sterile Micro Hook Blade
Product Usage:
The blade is intended to release A-1 pulley in endoscopic trigger release procedures. Terminated |
NBH | None listed |
| Mar 19, 2012 | Integra LifeSciences Corp. Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is kitted within an instrumentation tray. The Integra EGR System includes a range of instruments for en Terminated |
NBH | None listed |
| Oct 12, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Aimer Endofemoral 4mm Offset (Green)
Catalog Number: 72201716F (Refurbished)
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Terminated |
NBH | None listed |
| Oct 12, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Aimer Endofemoral 4mm Offset (Red)
Catalog Number: 72201715F (Refurbished)
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Terminated |
NBH | None listed |
| Oct 12, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Aimer Endofemoral 4mm Offset (Purple)
Catalog Number: 72201714F (Refurbished)
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Terminated |
NBH | None listed |
| Oct 12, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713F (Refurbished)
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Terminated |
NBH | None listed |
| Oct 12, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Aimer Endofemoral 7mm Offset (Gold)
Catalog Number: 72201717
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Terminated |
NBH | None listed |
| Oct 12, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Aimer Endofemoral 6mm Offset (Green)
Catalog Number: 72201716
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Terminated |
NBH | None listed |
| Oct 12, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Aimer Endofemoral 5mm Offset (Red)
Catalog Number: 72201715
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Terminated |
NBH | None listed |
| Oct 12, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Aimer Endofemoral 4mm Offset (Purple
Catalog Number: 72201714
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Terminated |
NBH | None listed |
| Oct 12, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Aimer Endofemoral 3mm Offset (Blue)
Catalog Number: 72201713
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Terminated |
NBH | None listed |
| Jan 19, 2010 | TAG Medical Corp. Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair.
Catalog Number: SMB000101 Terminated |
NBH | None listed |
| Nov 24, 2009 | Smith & Nephew, Inc., Endoscopy Div. AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device. Terminated |
NBH | None listed |
| Nov 24, 2009 | Smith & Nephew, Inc., Endoscopy Div. AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716.
The product is an orthopedic device. Terminated |
NBH | None listed |
| Nov 24, 2009 | Smith & Nephew, Inc., Endoscopy Div. AlMER ENDOFEMORAL 4MM OFFSET (PURPLE)
Part Number 72201714.
The product is an orthopedic device. Terminated |
NBH | None listed |
| Jul 14, 2009 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Endoscopic Disposable Blades:TURBOWHISKER BLD,EP-1,4.5MM(6)
Part #: 7205316.
DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft Terminated |
NBH | None listed |
| Jul 14, 2009 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Endoscopic Disposable Blades:
INCISOR BLADE,3.5MM DSPL,EP-1
Part #: 7205312.
DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft a Terminated |
NBH | None listed |
| Jul 14, 2009 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Endoscopic Disposable Blades:
BOXED F/R,BL,4.5MM,SERIES 3000 /6
Product #: 7206011.
DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of Terminated |
NBH | None listed |
| Jul 14, 2009 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Endoscopic Disposable Blades:
DISPOSABLE BL,4.5MM FR ELITE
Part #: 7210499.
DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft an Terminated |
NBH | None listed |
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