Panels › General, Plastic Surgery › Product code MDM · Class 1
Instrument, Manual, Surgical, General Use
Regulation 878.4800
0510(k)s in 12 months (44 all time)
1recalls in 12 months (77 all time)
3recalls that name a 510(k)
Top companies in MDM
| Company | 510(k)s | Recalls |
|---|---|---|
| Ethicon Endo-Surgery | 0 | 38 |
| Stryker Spine | 0 | 14 |
| Biomet, Inc. | 0 | 5 |
| Savoy Medical Supply Co., Inc. | 4 | 0 |
| Falcon Instruments, Inc. | 3 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 3 |
| Acuderm, Inc. | 2 | 0 |
| Applied Medical Resources Corp | 0 | 2 |
| Deroyal Industries, Inc. | 2 | 0 |
| Trilliant Surgical Ltd. | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Healthmark Industries Co., Inc. Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUA Open, Classified |
MDM | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) NAIL PACK, Model Number: SUT15830A; Open, Classified |
MDM | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor Open, Classified |
MDM | None listed |
| Apr 2, 2024 | Technicality Inc. Trumpet, Needle Guide, Cat# TMS-200 Open, Classified |
MDM | None listed |
| Mar 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion STERILE #16 RUBBER BAND, Product Code EB16 Open, Classified |
MDM | None listed |
| Mar 27, 2024 | Applied Medical Resources Corp Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers:
GK1003, AME Kit 54562
GK1004, KIT LAP CHOL DEN HOED 2,
GK1005, K2550 - HPATECTOMIE ERASME,
GK101 Open, Classified |
MDM | None listed |
| Mar 27, 2024 | Applied Medical Resources Corp Epix Universal Clip Applier, REF: CA500, STERILEEO Open, Classified |
MDM | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following: IM NAIL Open, Classified |
MDM | None listed |
| Dec 30, 2022 | ENDO Pharmaceuticals Solutions, Inc. 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants
Part Number: 50134-01 Open, Classified |
MDM | None listed |
| Dec 8, 2022 | Arthrex, Inc. Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile. Open, Classified |
MDM | None listed |
| Dec 22, 2021 | FlexDex Inc. 8mm FlexDex Needle Driver, Product Code FD-335 ND Terminated |
MDM | None listed |
| Mar 27, 2018 | Trilliant Surgical Ltd. Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile Terminated |
MDM | None listed |
| Mar 27, 2018 | Trilliant Surgical Ltd. Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile Terminated |
MDM | None listed |
| Dec 22, 2017 | Medtronic Sofamor Danek USA Inc Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only Terminated |
MDM | None listed |
| Oct 23, 2017 | Smith & Nephew, Inc. Radial Osteotome Blade, REF 71369314.
Used for cutting or preparing bone. Terminated |
MDM | None listed |
| Jun 23, 2017 | Exactech, Inc. Truliant Tibial Trial Handle.
To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these inst Terminated |
MDM | None listed |
| Oct 9, 2014 | DePuy Orthopaedics, Inc. Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd.
The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out Terminated |
MDM | None listed |
| Aug 8, 2013 | SpineFrontier, Inc. T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A
T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal Terminated |
MDM | K092815 |
| Aug 9, 2012 | Stryker Spine Stryker Reliance AL Implant Blocker (Various sizes)
The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region Terminated |
MDM | None listed |
| Jul 6, 2011 | Stryker Instruments Division of Stryker Corporation Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700 (800) 253-3210.
This device is intended f Terminated |
MDM | None listed |
| Aug 16, 2010 | Biomet, Inc. Suture Lariat 45 Degree Dog Leg Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904025.
Used to pass suture through tissue. Terminated |
MDM | None listed |
| Aug 16, 2010 | Biomet, Inc. Suture Lariat 30 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904022.
Used to pass suture through tissue. Terminated |
MDM | None listed |
| Aug 16, 2010 | Biomet, Inc. SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Right, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904012.
Used to pass suture through tissue. Terminated |
MDM | None listed |
| Aug 16, 2010 | Biomet, Inc. SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904010.
Used to pass suture through tissue. Terminated |
MDM | None listed |
| Aug 16, 2010 | Biomet, Inc. SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904008.
Used to pass suture through tissue. Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 18 MM AVS TL Trial Spacer; Catalog number: 48389418.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 17 MM AVS TL Trial Spacer; Catalog number: 48389417
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended f Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 16 MM AVS TL Trial Spacer; Catalog number: 48389416.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 15 MM AVS TL Trial Spacer; Catalog number: 48389415.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 14 MM AVS TL Trial Spacer; Catalog number: 48389414.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 13 MM AVS TL Trial Spacer; Catalog number: 48389413.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 12 MM AVS TL Trial Spacer; Catalog number: 48389412.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 10 MM AVS TL Trial Spacer; Catalog number: 48389410.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended f Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 8 MM AVS TL Trial Spacer; Catalog number: 48389408.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended f Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 7 MM AVS TL Trial Spacer; Catalog number: 48389407.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended f Terminated |
MDM | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical systems, Inc, Convenience Kit REF/CAT no.: K09-07692 REVISION A , CUSTOM KIT Terminated |
MDM | None listed |
| Feb 3, 2009 | Stryker Spine Stryker AVS AL Spacer Trial Inserter;
Non Sterile. Catalog number: 48329800
Manufactured by Stryker Spine SAS, Cestas, France.
Distributed in USA by Osteonics Corp., Mahwah, NJ. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Bariatric Tray, Kit code KBW30. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Gastric Tray, Kit Code TNG89. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Gastric Tray, Kit Code TNG73. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Gastric Tray, Kit Code TNG42. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC69. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC61. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC20. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC15. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC12. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC06. Terminated |
MDM | None listed |
| Apr 27, 2005 | Ethicon Endo-Surgery FlexTrayTM Endopath Gen. Laparoscopy Tray, Kit Code TGL62. Terminated |
MDM | None listed |
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