Product code FXX— General, Plastic Surgery
Surgical Face Mask
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 607
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FXX
1–100 of 607- K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
- K252534 — Surgical Face Mask (Ear mount)
- K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252650 — Disposable Medical Face Mask
- K243342 — KP Protective Face Mask
- K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
- K252964 — PRIMED Surgical and Procedure Masks
- K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)
- K250082 — Procedure mask/Surgical mask/Face mask
- K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce
- K242502 — Aurelia Surgical Mask ASTM Level-3 (2130)
- K240916 — Surgical Face Mask (Tie on/ Ear loops)
- K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks
- K233723 — Medical surgical mask
- K232824 — FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
- K232777 — FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
- K232807 — Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
- K232812 — Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)
- K232806 — HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)
- K232968 — Grande Medical Masks, Model SF-600
- K232820 — HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
- K240258 — Disposable Medical Face Mask (M643BE)
- K232112 — R&G Surgical Mask
- K231719 — Medical Surgical Mask
- K232894 — HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)
- K232797 — Hygenix
- K231005 — Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
- K231155 — Biodegradable Medical surgical mask
- K232359 — Surgical face mask
- K230380 — Surgical Face Masks, Model: EFMDS-L50Pn BLU
- K231618 — 3 Layer Surgical Mask (134252531)
- K230395 — Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
- K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
- K230617 — Surgical Face Mask (L 175*95mm)
- K222545 — Disposable Medical Mask
- K223823 — Disposable Surgical Face Mask
- K223236 — Medline Surgical Face Mask and Medline Procedural Face Mask
- K221352 — Surgical Face Mask
- K221209 — PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
- K223232 — Procedure mask/Surgical mask/Face mask
- K230383 — Savvy Surgical Mask - Level 3
- K230093 — Disposable 4 Layers Surgical Face Mask
- K223686 — Medical Protective Masks
- K221682 — Ideal Med Pro 3-Ply Disposable Face Mask
- K203380 — Disposable Surgical Face Mask
- K222483 — Surgical Face Mask
- K222809 — Medical Disposable Face Masks
- K213601 — Surgical Mask
- K220520 — PM Excellence SEQUR 100 Surgical Face Mask
- K222651 — Surgical Face Mask
- K223045 — 3-Ply Disposable Medical Mask
- K223055 — Disposable Medical Face Mask
- K223068 — Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
- K223003 — Banded Face Mask
- K203528 — KNH Surgical Face Mask
- K220302 — Disposable surgical face mask
- K222529 — Surgical Face Mask
- K222749 — High Fluid-Resistant Surgical and Procedure Mask
- K222551 — Humask Pro Vision, Humask Pro Vision 3000
- K222697 — Disposable Medical Face Mask (DF3-001)
- K223270 — POSE Health Care Surgical Mask
- K212649 — Disposable Surgical Face Mask
- K222335 — Surgical Mask
- K222266 — Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
- K222204 — Medical Surgical Mask
- K221976 — Surgical Face Mask (Non-sterile)
- K212926 — AllureTM Surgical Mask
- K221534 — Surgical Face Masks (Ear Loops And Tie-On)
- K214035 — LAITEST Medical Face Mask
- K220944 — PointCore Surgical Mask
- K221957 — Savewo ClassicMASK
- K222426 — Perfetta Moderate Medical Face Mask
- K221038 — Disposable Medical Masks
- K220067 — Medical Surgery Mask, Model:2626-7
- K211771 — The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask
- K203078 — CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
- K212273 — Cross Protection ResQ300 Plus Surgical Face Mask
- K221838 — Surgical Face Mask (HNFM0103)
- K220876 — AOK 95A Medical Mask (20200049)
- K221409 — Paneffort 3-ply Surgical and Procedural Masks
- K221196 — Disposable Medical Face Mask (ear loop)
- K220777 — Surgical face mask
- K221173 — Surgical Mask (Model: 0868F, 0866F)
- K220378 — Sparta 3-Ply Surgical Disposable Face Mask
- K220670 — Magnum
- K221272 — Medical Face Mask
- K221273 — Medical Face Mask (M001)
- K220377 — Procedure Mask
- K220550 — Disposable Surgical Face Mask (M663BE, M663BT)
- K221222 — Surgical Face Mask (HNFM0304)
- K220597 — Disposable Surgical Face Mask (FM-34EE,FM-44EE)
- K220191 — Disposable Face Mask
- K220532 — Disposable surgical mask
- K220824 — Medical Surgical Mask (Planar type)
- K221134 — Procedure Mask with Ear Loops and Surgical Mask with Ties
- K220194 — Procedure mask/Surgical mask/Face mask
- K220749 — Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
- K213001 — Procedure Mask, Surgical Mask
- K220487 — Disposable Medical Face Mask
Data sourced from openFDA. This site is unofficial and independent of the FDA.