WONDFO USA CO., LTD.
10 recalls · 2 adverse events · 2 clearances · 2 inspections · aggregated across 3 source records
Scorecard
Events per device across the 473-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
473 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Preview | PRE-STA-25 | GTY | 00816862023589 | 2 |
| Preview | PRE-FIT-30A | KHE | 00816862021134 | 1 |
| Preview | PRE-STA-10 | GTY | 00816862023725 | 1 |
| Preview | PRE-FIT-25KIT | KHE | 00816862021578 | 1 |
| Preview | PRE-FIT-OTC | KHE | 00816862021141 | 1 |
| Preview | PRE-FIT-KIT | KHE | 00816862021127 | 1 |
| Preview | PRE-FIT-25A | KHE | 00816862021561 | 1 |
| Prime Screen | DWDTH-101-20BX-CUP-A | LDJ | 00816862027327 | 1 |
| Prime Screen® | DCDOA-L964-5BX-A | LCM NFT NFW NFY NGL | 00810174471229 | 1 |
| SAFElife™ | CDOA-L11145 | LCM NFT NFV NFW NFY NGG NGL PTG PTH QAW | 00816862028027 | 1 |
| SAFElife™ | CDOA-L13145NT | LCM NFT NFV NFW NFY NGG NGL PTG PTH | 00816862028713 | 1 |
| SAFElife™ | CDOA-12135NT | LCM NFT NFV NFY NGG NGL PTG PTH QAW | 00816862028249 | 1 |
| SAFElife™ | CDOA-L11135A3 | LCM NFT NFV NFW NFY NGG NGL PTG PTH | 00816862028294 | 1 |
| SAFElife™ | TDOA-6135F | LCM NFT NFV NFW NFY NGG NGL PTG PTH | 00816862028362 | 1 |
| SAFElife™ | CDOA-6135F | LCM NFT NFV NFW NFY NGG NGL PTG PTH | 00816862028348 | 1 |
| SAFElife™ | CDOA-L11135A3 | LCM NFT NFV NFW NFY NGG NGL PTG PTH | 00816862028089 | 1 |
| T-Cup | TDOA-1145A3 | DIO DIS DJG DJR DKZ JXM JXN LAF LCM LDJ LFG | 00816862020076 | 1 |
| T-Cup | TDOA-1145A3 | DIO DIS DJG DJR DKZ JXM JXN LAF LCM LDJ LFG | 00816862025071 | 1 |
| WELLlife™ | WFOB-OTC-1BX | KHE | 00816862025972 | 1 |
| WELLlife™ | WCOV-POC-T25C1 | QVF | 00816862028577 | 1 |
| WELLlife™ | WCOV-POC-25 | QYT | 00816862027280 | 1 |
| WELLlife™ | WL03P0001-2S | QYT | 00816862027402 | 1 |
| WELLlife™ | WFOB-OTC-2BX | KHE | 00816862028324 | 1 |
| Wondfo Drug Test Dip Card | WDBU-114 | DJG | 00816862025415 | 1 |
| Wondfo Key Cup | KDOA-3104 | DIO DIS DJG DJR DKZ JXM LAF LCM LDJ | 00816862020038 | 1 |
| Wondfo Key Cup | KDOA-7104 | DIO DIS DJG DJR JXM LAF LDJ LFG | 00816862020045 | 1 |
| Wondfo Key Cup | KDOA-264 | DIO DJG DKZ JXM LAF LDJ | 00816862020014 | 1 |
| Wondfo Key Cup | KDOA-274 | DIO DJG DKZ JXM LAF LDJ | 00816862025026 | 1 |
| Wondfo Key Cup | KDOA-264 | DIO DJG DKZ JXM LAF LDJ | 00816862025019 | 1 |
| Wondfo Key Cup | KDOA-3104 | DIO DIS DJG DJR DKZ JXM LAF LCM LDJ | 00816862025033 | 1 |
Showing 1–30 of 473Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3007606081 | WONDFO USA CO., LTD. | Bolingbrook, IL, US | VAI | |
| 3016252795 | Wondfo USA Co., Ltd. | San Diego, CA, US | — |