Aesculap AG
6078 adverse events · 149 recalls · 64 clearances · 36 inspections · 2 compliance actions · aggregated across 6 source records
Scorecard
Events per device across the 25,238-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.017 ▼
429 in the last 12 months
Higher volume than 88% of companies with 10+ devices
Recalls per device
0.000 →
10 in the last 12 months
Higher volume than 98% 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
25,238 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| PROGAV 2.0 | FX642T | JXG | 04041906502003 | 56 |
| M.BLUE | FX801T | JXG | 04041906504403 | 52 |
| M.BLUE PLUS | FX824T | JXG | 04041906504830 | 52 |
| AESCULAP | GD670 | HBC | 04038653347551 | 51 |
| AS VEGA System® PS | NX033Z | JWH | 04046963810207 | 49 |
| AESCULAP | PM973R | GEI | 04038653183715 | 48 |
| CRANIOFIX® ABSORBABLE | FF016 | GXR | 04038653348398 | 48 |
| MICRO-LINE | GD450M | HWE | 04038653444885 | 48 |
| AESCULAP | US354 | GEI | 04046964582820 | 47 |
| AS VEGA System® PS | NX056Z | JWH | 04046963810474 | 47 |
| AESCULAP | FF904SB | LXH | 04038653364312 | 46 |
| M.BLUE | FX802T | JXG | 04041906504410 | 45 |
| AESCULAP | PL536R | OCW | 04038653241149 | 42 |
| AESCULAP | PL520R | FZP | 04046963313173 | 41 |
| AESCULAP | BA823SU | GDX | 04046963840853 | 41 |
| AS VEGA System® PS | NX013Z | JWH | 04046963809942 | 39 |
| AESCULAP | NX042 | JWH | 04046963810283 | 38 |
| AS | NN261Z | JWH | 04046963124502 | 38 |
| CRANIOFIX® ABSORBABLE | FF017 | GXR | 04038653348404 | 38 |
| AESCULAP | BH145R | HRQ | 04038653025800 | 37 |
| ENDURO | NR880M | KRO | 04046964010286 | 37 |
| AESCULAP | JK090 | FLE FRG KCT | 04038653202690 | 36 |
| AESCULAP | PL770SU | GEI | 04046964837067 | 36 |
| VEGA System® PS+ | NX230 | JWH | 04046963811242 | 36 |
| AS VEGA System® PS | NX049Z | JWH | 04046963810337 | 35 |
| AESCULAP | PO888 | GEI | 04038653368976 | 34 |
| AESCULAP | NX044 | JWH | 04046963810306 | 34 |
| AS | NN264Z | JWH | 04046963124519 | 34 |
| VEGA System® PS+ | NX220 | JWH | 04046963811181 | 34 |
| AESCULAP | FF013P | HBO | 04038653221875 | 33 |
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2011-09-26 | WL | Warning Letter | Aesculap AG |
| 2011-09-26 | WL | Warning Letter | Aesculap AG |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3002806315 | AESCULAP AG | TUTTLINGEN, DONAU Baden-Wurttemberg, DE | NAI | |
| 3001354499 | AESCULAP SAS | CHAUMONT Grand Est, FR | — | |
| 2916714 | AESCULAP, INC. | CENTER VALLEY, PA, US | NAI | |
| 3003587896 | AESCULAP, INC. | HAZELWOOD, MO, US | VAI | |
| 3008711893 | B.Braun Medical (Suzhou) Co,.Ltd | Suzhou Jiangsu, CN | — |