Product code LMH ยท Class 3
Implant, Dermal, For Aesthetic Use
0510(k)s in 12 months (0 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in LMH
| Company | 510(k)s | Recalls |
|---|---|---|
| Merz Aesthetics, Inc. | 0 | 2 |
| Merz North America, Inc. | 0 | 2 |
| Enhancement Medical, LLC | 0 | 1 |
| Orthovita, Inc., dBA Stryker Orthobiologics. | 0 | 1 |
| Prollenium Medical Technologies Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2018 | Prollenium Medical Technologies Inc. Revanesse Versa, PN40081 Terminated |
LMH | None listed |
| Aug 19, 2016 | Merz North America, Inc. Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics.
Product Usage:
RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe fa Terminated |
LMH | None listed |
| Dec 3, 2015 | Merz North America, Inc. Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds. Terminated |
LMH | None listed |
| Mar 30, 2015 | Orthovita, Inc., dBA Stryker Orthobiologics. Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or imp Terminated |
LMH | None listed |
| Aug 8, 2014 | Enhancement Medical, LLC Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml.
Product Usage: Expression is labelled as an Intranasal Splint, intend Terminated |
LMH | None listed |
| Nov 1, 2011 | Merz Aesthetics, Inc. MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY.
Part Number 8071M4K1 distributed in Canada
Part Number 8071M5 distributed i Terminated |
LMH | None listed |
| May 19, 2011 | Merz Aesthetics, Inc. Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 5 Terminated |
LMH | None listed |
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