12 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
FDA Enforcement
Class II
·Ongoing·Medline Industries Inc·April 21, 2021
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
FDA Enforcement
Class II
·Ongoing·Stanbio Laboratory, LP·December 13, 2023
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
FDA Enforcement
Class II
·Ongoing·EHOB, Inc.·June 30, 2021
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
FDA Enforcement
Class II
·Ongoing·IHB OPERATIONS B.V.·April 30, 2025
Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.
FDA Enforcement
Class II
·Ongoing·IHB OPERATIONS B.V.·December 13, 2023
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
FDA Enforcement
Class II
·Ongoing·Withings·March 29, 2023