32 results
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7ms
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Sources: EU EUDAMED, US FDA
LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
FDA Enforcement
Class II
·Ongoing·Hill-Rom, Inc.·October 6, 2021
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
FDA Enforcement
Class II
·Ongoing·Corin Ltd·December 28, 2022
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
FDA Enforcement
Class II
·Ongoing·Corin Ltd·December 28, 2022
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·December 20, 2023
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
FDA Enforcement
Class II
·Ongoing·CORENTEC CO., LTD·June 12, 2024
See Luer Cap Set, MPC-130, set, administration, intravascular
FDA Enforcement
Class II
·Ongoing·Molded Products Inc·April 15, 2026
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