28 results · 14ms · Sources: EU EUDAMED, US FDA

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The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

FDA Enforcement
Class II ·Ongoing·Vision RT Ltd·January 14, 2026

Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Model Number: DYNJ40573A; 6) C-SECTION CDS, Model Number: CDS983998C; 7) C-SECTION ADD ON PACK, Model Number: DYNJ64300A; 8) EMERGENCY BIRTH PACK, Model Number: DYNJ55205; 9) C-SECTION PACK, Model Number: DYNJ56550; 10) C-SECTION ADD ON PACK, Model Number: DYNJ83507; 11) C-SECTION CLOSURE PACK, Model Number: DYNJ83248; 12) C-SECTION PCH-LF, Model Number: DYNJ81281

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025

human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

FDA Enforcement
Class II ·Ongoing·HUMAN MED AG·March 12, 2025

Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

FDA Enforcement
Class II ·Ongoing·Oto Med Inc·May 12, 2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

FDA Enforcement
Class II ·Ongoing·Oto Med Inc·May 12, 2021

DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

FDA Enforcement
Class II ·Ongoing·Oto Med Inc·May 12, 2021

NEO DELTA Self Safe, I.V. Catheter REF 3738222

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter:

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072

FDA Enforcement
Class II ·Ongoing·Delta Med SpA·August 25, 2021

Med-Riser MR600 Patient Lift

FDA Enforcement
Class II ·Ongoing·Med-Mizer, Inc.·March 8, 2023

Sit to Stand STS500 Patient Lift

FDA Enforcement
Class II ·Ongoing·Med-Mizer, Inc.·March 8, 2023

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

FDA Enforcement
Class II ·Ongoing·Inter-Med Llc·June 17, 2026