FDA Device Intelligence
Home › AMBLER SURGICAL CORP. › Ambler Surgical

Ambler Surgical

AMBLER SURGICAL CORP. · Model Davis mouth gag complete set includes - left and right adult frames · UDI-DI 00190660112288

KBN Prescription
3
510(k) clearances
47
Adverse events
1
Recalls
213
Facilities

Description

Davis mouth gag complete set includes - left and right adult frames, 8 blades (46-115, 46-120, 46-100, 46-101, 46-102, 46-103, 46-104, 46-105, 46-106 and 46-108)

Recalls

DateFirmReason
2018-02-16Aesculap Implant Systems LLCThe plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.