Panels › General, Plastic Surgery › Product code MMP · Class 2
Cover, Barrier, Protective
Regulation 878.4370
0510(k)s in 12 months (15 all time)
0recalls in 12 months (30 all time)
30recalls that name a 510(k)
Top companies in MMP
| Company | 510(k)s | Recalls |
|---|---|---|
| Smiths Medical MD, Inc. | 0 | 12 |
| GE Medical Systems, LLC | 0 | 5 |
| NOVADAQ TECHNOLOGIES INC. | 0 | 3 |
| Covidien LLC | 0 | 2 |
| Hydro-Med Products, Inc. | 1 | 1 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 2 |
| Stryker Corporation | 0 | 2 |
| Wrapped IN Comfort | 2 | 0 |
| Contour Fabricators, Inc. | 1 | 0 |
| Cottrell, Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following:
a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900;
b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Mode Open, Classified |
MMP | K032065 K130581 |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures Open, Classified |
MMP | K032065 |
| Jan 7, 2020 | Stryker Corporation Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326 Open, Classified |
MMP | K041501 |
| Jan 7, 2020 | Stryker Corporation Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US.
Drape/ UDI: HH2000/10858701006329;
HH9006/ 10858701006282 Open, Classified |
MMP | K162885 |
| Jun 27, 2017 | NOVADAQ TECHNOLOGIES INC. NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada.
The SPY-PHI Drape is inten Terminated |
MMP | K041501 |
| Jun 27, 2017 | NOVADAQ TECHNOLOGIES INC. NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as sing Terminated |
MMP | K041501 |
| Jun 27, 2017 | NOVADAQ TECHNOLOGIES INC. NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada.
The SPY-PHI Drape is intended to cov Terminated |
MMP | K041501 |
| Jan 23, 2017 | Covidien LLC Premier Guard Drape, Sterile.
For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044)
Item Number: 01-0037
Used in conjunction RF Surgical Gauze detection systems to protect scanning device from c Terminated |
MMP | K041501 |
| Jan 23, 2017 | Covidien LLC Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046)
Item Number: 01-0020
Used in conjunction RF Surgical Gauze detection systems to protect scanning dev Terminated |
MMP | K041501 |
| Mar 20, 2015 | Penner Mfg Inc Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1
The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nu Terminated |
MMP | K962288 |
| Mar 18, 2015 | Sybron Dental Specialties Outer cardboard box labeling:
Pinnacle Cure Sleeve, Curing Light Tip Sleeves.
Kerr Total Care.
Part Number: 4513C or 4513-1
Single Patient Use
Fits 13mm Tips. Pack of 400.
Metrex Research, Manufa Terminated |
MMP | K962288 |
| Nov 27, 2012 | Metrex Research, LLC. Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier
The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fl Terminated |
MMP | K962288 |
| Sep 1, 2009 | GE Medical Systems, LLC Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper). Terminated |
MMP | K021049 K782155 +3 |
| Sep 1, 2009 | GE Medical Systems, LLC Sterile, Drape, Headset, Upper, Part Number 888945-01. Terminated |
MMP | K021049 K782155 +3 |
| Sep 1, 2009 | GE Medical Systems, LLC Sterile, Drape, Headset, Lower, Part Number 888944-01. Terminated |
MMP | K021049 K782155 +3 |
| Sep 1, 2009 | GE Medical Systems, LLC GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA. Terminated |
MMP | K021049 K782155 +3 |
| Aug 14, 2009 | GE Medical Systems, LLC GE Healthcare, Drapes and Sterile Covers
PART NUMBER DESCRIPTION
00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL
00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AN Terminated |
MMP | K021049 K782155 +3 |
| Oct 24, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Terminated |
MMP | K992880 |
| Oct 24, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Poly Terminated |
MMP | K871132 K931073 +1 |
| Oct 24, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Pol Terminated |
MMP | K942024 |
| Oct 24, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Pol Terminated |
MMP | K942024 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Dual-lumen Fluoro-Free Venous Access System, Dual Lumen Si Terminated |
MMP | K871132 K932841 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Terminated |
MMP | K992880 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Po Terminated |
MMP | K942024 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Po Terminated |
MMP | K871132 K931073 +1 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Po Terminated |
MMP | K942024 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Po Terminated |
MMP | K942024 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Venous Access System, PolyFlow Polyurethane C Terminated |
MMP | K871132 K931073 |
| Apr 27, 2006 | Smiths Medical MD, Inc. Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Venous Access System, PolyFlow Polyurethane C Terminated |
MMP | K871132 K931073 +1 |
| Jan 6, 2005 | Hydro Med Products, Inc Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983; Manufactured by Hydo-Med Products Inc., 2930 Ladybird Ln., Dallas, TX 75220 Terminated |
MMP | K940151 |
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