Elephant Hawk
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Context Brief
| Date | Kind | Sponsor | Country | Code | Class | Device | Doc |
|---|---|---|---|---|---|---|---|
| 2026-05-16 | 510k | L&K BIOMED Co., Ltd. | KR | ODP | II | BluEX Cervical Expandable Cage System | K260840 |
| 2026-05-15 | pma | Ventana Medical Systems, Inc. | — | MVC | III | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | P990081-S058 |
| 2026-05-15 | pma | Medtronic Cardiac Rhythm Disease Management | — | LWS | III | Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, | P980016-S958 |
| 2026-05-15 | pma | Boston Scientific | — | NVN | III | Fixation Tool (Model 6616) | P960006-S059 |
| 2026-05-15 | pma | Boston Scientific | — | NVN | III | Stylet (Models 6033, 6034, 6036, 6037, 6039, 6040, 6042, 6043, 6053, 6054, 6055, | P960004-S115 |
| 2026-05-15 | pma | Biotronik, Inc. | — | DXY | III | Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Ele | P950037-S292 |
| 2026-05-15 | pma | Boston Scientific | — | LWS | III | Hex Wrench (#2) (Model 6501) | P930035-S037 |
| 2026-05-15 | pma | Boston Scientific | — | LWS | III | DF-1 Plug (Model 6996) | P910077-S199 |
| 2026-05-15 | pma | Boston Scientific | — | LWS | III | ACUITY X4 Connector Tool (Model 4625); RELIANCE 4-FRONT Suture Sleeve (aka Lea | P910073-S190 |
| 2026-05-15 | pma | Boston Scientific | — | LWS | III | Vein Pick (Model 6541) | P830060-S093 |
| 2026-05-15 | pma | Natera, Inc. | — | PQP | III | Signatera CDx | P260004 |
| 2026-05-15 | pma | Medtronic, Inc. | — | QZI | III | Sphere-9 Catheter and Affera Ablation System | P240013-S025 |
| 2026-05-15 | pma | Abbott Molecular, Inc. | — | MAQ | III | Alinity m HR HPV | P230003-S013 |
| 2026-05-15 | pma | ABBOTT MEDICAL | — | OAE | III | TactiFlex Ablation Catheter, Sensor Enabled (A-TFSE-D; A-TFSE-F; A-TFSE-J; A-T | P220013-S029 |
| 2026-05-15 | pma | Ventana Medical Systems, Inc. | — | NYQ | III | HER2 Dual ISH DNA Probe Cocktail | P190031-S015 |
| 2026-05-15 | pma | Alcon Laboratories, LLC | — | HQL | III | Clareon Vivity Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens | P190018-S046 |
| 2026-05-15 | pma | Boston Scientific | — | LWP | III | Stylet Models (5003, 5004, 5005, 5012, 5013, 5014); INGEVITY Attachable Suture | P150012-S183 |
| 2026-05-15 | pma | Q-Med AB | — | LMH | III | Restylane® Contour | P140029-S057 |
| 2026-05-15 | pma | St Jude Medical | — | OAE | III | TactiCath CF Ablation Catheter, Sensor Enabled (A-TCSE-D; A-TCSE-F; A-TCSE-J; | P130026-S099 |
| 2026-05-15 | pma | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | — | OUT | III | Pipeline Flex Embolization Device (Pipeline Flex); Pipeline Flex Embolization | P100018-S053 |
| 2026-05-15 | pma | Bard Peripheral Vascular, Inc. | — | NIP | III | LifeStent 5F Vascular Stent System | P070014-S068 |
| 2026-05-15 | pma | Medtronic Cardiac Rhythm Disease Management | — | NIK | III | Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2 | P010031-S925 |
| 2026-05-15 | pma | Zoll Manufacturing Corporation | — | MVK | III | LifeVest® Wearable Defibrillator | P010030-S200 |
| 2026-05-15 | pma | Boston Scientific Corp | — | NIK | III | ACUITY X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY X4 Flushing | P010012-S608 |
| 2026-05-15 | 510k | Medicrea International S.A.S. (Medtronic) | FR | QIH | II | UNiD Spine Analyzer (SW3002) | K261289 |
| 2026-05-15 | 510k | Neurophet., Inc. | KR | QIH | II | Neurophet AQUA | K261273 |
| 2026-05-15 | 510k | Bausch and Lomb | US / MO | HQC | II | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pac | K261264 |
| 2026-05-15 | 510k | Kyocera Medical Technologies Inc. (KMTI) | US / CA | NKB | II | Varion Thoracolumbar Fixation System | K260989 |
| 2026-05-15 | 510k | Boston Scientific Corporation | US / MA | KRA | II | TruSelect 2.6 Microcatheter | K260771 |
| 2026-05-15 | 510k | Depuy Ireland UC | IE | KWL | II | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | K260536 |
Firms that recently tripped the distress signal: small US-cleared portfolio (≤8 clearances), Class I recall in the window, dormant ≥730 days. Potential M&A targets via Hilco / Ocean Tomo / Heritage Global outreach.
| Firm | Country | Code | Total US Clearances | Class I Recalls | Last Clearance | Last Recall |
|---|---|---|---|---|---|---|
| Cook Incorporated | US | MMX | 6 | 3 C1 | 2024-03-08 | 2026-04-02 |
| Cook Incorporated | US | DRE | 6 | 3 C1 | 2024-03-08 | 2026-04-02 |
| Cook Incorporated | US | MQK | 6 | 3 C1 | 2024-03-08 | 2026-04-02 |
| Cook Incorporated | US | LJE | 6 | 3 C1 | 2024-03-08 | 2026-04-02 |
| Cook Incorporated | US | OQY | 6 | 3 C1 | 2024-03-08 | 2026-04-02 |
| Cook Incorporated | US | DYB | 6 | 3 C1 | 2024-03-08 | 2026-04-02 |
v0 of the Market Pulse uses FDA Radar warehouse data only. The following external signal sources are planned and will land in subsequent sprints — each layers cleanly on this same brief.