28 results
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8ms
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Sources: EU EUDAMED, US FDA
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 labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2519H ; 5) PRE-OP PREP KIT , Pack Number DYNDA3076; 6) PILGRIM PREP TRAY , Pack Number DYNDC3282; 7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ; 8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ; 9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ; 10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ; 11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ; 12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ; 13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ; 14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ; 15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ; 16) PK-SETUP PACK , Pack Number DYNJ43804A ; 17) SKIN LESION PACK, Pack Number DYNJ44258G ; 18) SETUP PACK, Pack Number DYNJ46187D ; 19) PK-SET UP -LF , Pack Number DYNJ53220B ; 20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ; 21) SKIN SCRUB PACK , Pack Number DYNJ68561; 22) DMEK PREP PACK, Pack Number DYNJ81659A ; 23) SET UP PACK , Pack Number DYNJ84247; 24) BASIC SET UP PACK-LF, Pack Number DYNJ85036; 25) SET UP CDS-ASC, Pack Number DYNJ900073C; 26) GENERAL SET UP, Pack Number DYNJ906282C; 27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A; 28) SET UP, Pack Number DYNJ909403 ; 29) PREP TRAY , Pack Number DYNJRA1280A; 30) PREP TRAY , Pack Number DYNJRA1424 ; 31) NERVE BLOCK/W , Pack Number DYNJRA1424H; 32) PREP TRAY, Pack Number DYNJRA1498B; 33) PREP TRAY , Pack Number DYNJRA1583C; 34) PREP TRAY , Pack Number DYNJRA1760 ; 35) PREP TRAY , Pack Number DYNJRA1774 ; 36) PREP TRAY , Pack Number DYNJRA1783 ; 37) PREP TRAY , Pack Number DYNJRA1946A; 38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ; 39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
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