calendar

Mar 31, 2026device adverse event154d agoGLIDEWELL HT IMPLANT Ø5.0 X 10 MM — Injury event

Failure to Osseointegrate

Mar 31, 2026device adverse event154d agoIMPELLA — Death event

Patient Device Interaction Problem

Mar 31, 2026device adverse event154d agoASTRATECH IMPL EV 4.2S 9MM OS — Injury event

Loss of Osseointegration

Mar 31, 2026device adverse event154d agoARTICULATION KIT SIZE 5/6 — Injury eventZIMMER BIOMET HOLDINGS, INC.

Adverse Event Without Identified Device or Use Problem

Mar 31, 2026device adverse event154d agoMENTOR MEMORYGEL BREAST IMPLANT — Injury event

Material Rupture

Mar 31, 2026device adverse event154d agoULNAR-STEM-SZ5-115MM-RT — Injury eventZIMMER BIOMET HOLDINGS, INC.

Adverse Event Without Identified Device or Use Problem

Mar 31, 2026device adverse event154d agoMENTOR MEMORYGEL BREAST IMPLANT — Injury event

Material Rupture

Mar 31, 2026device adverse event154d agoHUMERAL-SCREW-KIT — Injury eventZIMMER BIOMET HOLDINGS, INC.

Adverse Event Without Identified Device or Use Problem

Mar 31, 2026device adverse event154d agoANK C/X IMPL A9.5/D3.5/L9.5 — Injury event

Loss of Osseointegration

Mar 31, 2026device adverse event154d agoNUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE — Injury event

Failure to Read Input Signal

Mar 31, 2026device adverse event154d agoNUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE — Injury event

Failure to Read Input Signal

Mar 31, 2026device adverse event154d agoGLOBAL AP HUMERAL STEM 14MM — Injury event

Adverse Event Without Identified Device or Use Problem

Mar 31, 2026device adverse event154d agoOMNILINK ELITE — Injury event

Difficult to Advance; Device Dislodged or Dislocated

Mar 31, 2026device adverse event154d agoOSSEOSPEED 4.5 - 13 MM — Injury event

Fracture

full page →nih reporter ↗

Mar 31, 2026grant154d agoTULANE UNIVERSITY OF LOUISIANA — Development of a Rhesus Macaque Model of Persistent Oral HPV and HIV Co-infec...

DE grant. $44,984. PI: Prasun K Datta

Mar 31, 2026grant154d agoUNIV OF MASSACHUSETTS MED SCH WORCESTER — Determine the role of a monocarboxylate transporter in metabolism and intesti...

DK grant. $34,272. PI: Rebekka Hannah Anderson

full page →nih reporter ↗

Apr 1, 2026approval153d agoLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

Apr 1, 2026approval153d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: SUN PHARM. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: SUN PHARM. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: SUN PHARM. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →vadadustat →fda approvals ↗

Apr 1, 2026approval153d agoVAFSEO (VADADUSTAT) — FDA approvalvadadustat

Sponsor: AKEBIA. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoKESIMPTA (OFATUMUMAB) — FDA approvalKESIMPTA

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →KESIMPTA →fda approvals ↗

Apr 1, 2026approval153d agoLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

Apr 1, 2026approval153d agoLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

Apr 1, 2026approval153d agoLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

Apr 1, 2026approval153d agoLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (EPINEPHRINE) — FDA approvaladrenaline

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

Apr 1, 2026approval153d agoBREXPIPRAZOLE — FDA approvalBREXPIPRAZOLE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoBREXPIPRAZOLE — FDA approvalBREXPIPRAZOLE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoBREXPIPRAZOLE — FDA approvalBREXPIPRAZOLE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoBREXPIPRAZOLE — FDA approvalBREXPIPRAZOLE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoBREXPIPRAZOLE — FDA approvalBREXPIPRAZOLE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

full page →orforglipron calcium →fda approvals ↗

Apr 1, 2026approval153d agoFOUNDAYO (ORFORGLIPRON CALCIUM) — FDA approvalorforglipron calcium

Sponsor: ELI LILLY AND CO. Form: TABLET. Route: ORAL

Apr 1, 2026approval153d agoPROCHLORPERAZINE EDISYLATE — FDA approvalPROCHLORPERAZINE EDISYLATE

Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION

full page →PROCHLORPERAZINE EDISYLATE →fda approvals ↗

Apr 1, 2026recall153d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing

Apr 1, 2026recall153d agoMACLEODS PHARMA USA, INC recall (Cls II)Macleods Pharma USA Inc

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44 — Reason: Subpotent Drug — Status: Ongoing

Apr 1, 2026recall153d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing

Apr 1, 2026recall153d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing

Apr 1, 2026recall153d agoAmerisource Health Services LLC recall (Cls II)Casper Pharma LLC

Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217. — Reason: Failed tablet specifications. — Status: Ongoing

Apr 1, 2026recall153d agoRadnostix recall (Cls III)RADNOSTIX INC

Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 — Reason: Failed Tablet/Capsule Specifications — Status: Ongoing

Apr 1, 2026recall153d agoChiesi USA, Inc. recall (Cls II)Chiesi USA Inc

CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. — Reason: Lack of Assurance of Sterility — Status: Ongoing

Apr 1, 2026device 510k153d agoShenzhen HanHan Technology Co., Ltd. — Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) (510k cleared)Shenzhen Hanhui Pharmaceutical Technology Co Ltd

Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional

Apr 1, 2026device 510k153d agoStereotaxis, Inc. — Synchrony (510k cleared)Stereotaxis, Inc.

Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional

Apr 1, 2026device 510k153d agoRetmap, Inc. — RM Electrode (RMH 25-01) (510k cleared)

Product code: HLZ. Advisory committee: Ophthalmic. Type: Traditional

Apr 1, 2026device 510k153d agoApple, Inc. — Medical Imaging Calibration Feature (MICF) (510k cleared)Apple Inc.

Product code: SHN. Advisory committee: Radiology. Type: Traditional

Apr 1, 2026device 510k153d agoHudi Pharma Srl — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) (510k cleared)

Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional

Apr 1, 2026device 510k153d agoShenzhen AOJ Medical Technology Co., Ltd. — Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro (510k cleared)NewBay Medical Technology Co Ltd

Product code: DXN. Advisory committee: Cardiovascular. Type: Special