Stille AB
Torshalla Sodermanland, SE
STILLE AB appears in FDA device records in Torshalla Sodermanland, SE. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003696170 | 3003696170 | STILLE AB | Ekbacken 11, Torshalla Sodermanland SE-644 30 SE | 2026 | and 29 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KMEBedding, Disposable, Medical
- GEACannula, Surgical, General & Plastic Surgery
- KDGChisel (Osteotome)
- GDJClamp, Surgical, General & Plastic Surgery
- HTFCurette
- IWQCurtain, Protective, Radiographic
- GDIDissector, Surgical, General & Plastic Surgery
- HTEElevator
- KAEForceps, Ent
- GENForceps, General & Plastic Surgery
- GDHGouge, Surgical, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- GDZHandle, Scalpel
- HRQHemostat
- FHQHolder, Needle, Gastroenterologic
- HXKHolder, Needle; Orthopedic
- HXPInstrument, Bending Or Contouring
- LGGInstrument, Cast Application/Removal, Manual
- HTZInstrument, Cutting, Orthopedic
- HAOInstrument, Surgical, Non-Powered
- DWSInstruments, Surgical, Cardiovascular
- HTSKnife, Orthopedic
- HXLMallet
- FZZMarker, Skin
- HXBProbe
- HTRRasp
- GADRetractor
- HTXRongeur
- HSOSaw
- KBCSaw, Nasal
- LRWScissors, General, Surgical
- KBDScissors, Nasal
- HNFScissors, Ophthalmic
- HRRScissors, Orthopedic, Surgical
- FHLScoop
- EPYSpeculum, Ent
- HRTStripper, Surgical
- LGXTable, Examination, Medical, Powered
- GDCTable, Operating-Room, Electrical
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0566-2010 | Stille Sonesta Gynecology and Urology Table 6303 ; an electric cystometric table; Stille AB, Solna, Sweden. Used to position the subject/patient in a desired position during urodynamic, general examinations, cystoscopy, ultrasound, biofeedback, vasectomy and OBGYN procedures. | There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure. | Terminated | ||
| Z-0565-2010 | Stille Sonesta Gynecology and Urology Table 6302 and 6302U; an electric cystometric table; Stille AB, Solna, Sweden. Used to position the subject/patient in a desired position during urodynamic, general examinations, cystoscopy, ultrasound, biofeedback, vasectomy and OBGYN procedures. | There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure. | Terminated | ||
| Z-0564-2010 | Stille Sonesta Urodynamic Table 6202 Gynecology/Urology Procedure Chair; an electric cystometric table; Stille AB, Solna, Sweden. Used to position the subject/patient in a desired position during urodynamic, general examinations, cystoscopy, ultrasound, biofeedback, vasectomy and OBGYN procedures. | There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure. | Terminated | ||
| Z-0119-2009 | Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, SE-17173 Solna, Sweden | The table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically w | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain