Home › Device types › LMH
Implant, Dermal, For Aesthetic Use
FDA product code LMH · Class 3 · Unknown
217
Registered devices
22,594
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
RHA® Dynamic Volume — Teoxane SARestylane Refyne — Q-Med ABRestylane Silk-L — Q-Med ABRESTYLANE DEFYNE — SAIMA GLOBAL FARMA S.L.RHA® 3 — Teoxane SAJUVEDERM ULTRA PLUS XC — Allergan, Inc.Restylane Volyme + Lidocaine — LAMBSMEAD LTDRHA® 4 — Teoxane SAJuvederm Ultra Smile — LAMBSMEAD LTDBelotero Balance (+) Lidocaine — ANTEIS SARestylane 0.5 ML.+ Lidocaine — LAMBSMEAD LTDRestylane-L — Q-Med ABJUVEDERM ULTRA — Allergan, Inc.Restylane Kysse — Q-Med ABJUVEDERM ULTRA XC — Allergan, Inc.Restylane Lyft — Q-Med ABJuvederm Volift — LAMBSMEAD LTDJuvederm Ultra 4 — LAMBSMEAD LTDRestylane Eyelight — UNIVERDERMRestylane Contour — Q-Med ABRESTYLANE KYSSE — SAIMA GLOBAL FARMA S.L.Restylane-L — Q-Med ABRHA® 4 — Teoxane SARestylane Lyft with Lidocaine — Q-Med AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-15 | Prollenium Medical Technologies Inc. | Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months. |
| 2016-05-20 | Merz North America, Inc. | Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. |
| 2015-10-26 | Merz North America, Inc. | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. |
| 2015-02-26 | Orthovita, Inc., dBA Stryker Orthobiologics. | Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validate |
| 2013-08-07 | Enhancement Medical, LLC | Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to i |
| 2011-08-18 | Merz Aesthetics, Inc. | There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Profe |
| 2011-04-06 | Merz Aesthetics, Inc. | Merz Aesthetics, Inc. is recalling 1 lot (1034417) of Radiesse 1.3 cc Implant. The lot was supposed to be scrapped because it had failed to meet its Loss On Dry |
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