Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, or manufacturer
4,872
results for "Synthes (Usa)"
Cleared
Feb 10, 2026
multiFlux 130 (F00013123)
Fresenius Medical Care Renal...
Gastroenterology & Urology
189d
Cleared
Feb 10, 2026
NIM Essence™ EMG Endotracheal Tube (NIMEID060)
Medtronic Xomed, Inc.
Ear, Nose, Throat
256d
Cleared
Feb 09, 2026
Holter ECG and ABP system (HolterABP)
Edan Instruments, Inc.
Cardiovascular
262d
Cleared
Feb 06, 2026
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile...
Ethicon, Inc.
General & Plastic Surgery
66d
Cleared
Feb 06, 2026
SIGNA™ Bolt
Ge Medical Systems, LLC
Radiology
72d
Cleared
Feb 06, 2026
Hood DH-084STR
Fujifilm Corporation
Gastroenterology & Urology
81d
Cleared
Feb 06, 2026
Q Interbody Instruments
K2m, Inc.
Orthopedic
149d
Cleared
Feb 06, 2026
Spine Guidance 5.3 Software
Stryker Leibinger GmbH & Co KG
Orthopedic
149d
Cleared
Feb 06, 2026
IntelliVue Multi-Measurement Module X3 (867030)
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular
162d
Cleared
Feb 06, 2026
Stainless Steel Surgical Kits
Dentsply Sirona, Inc.
General Hospital
255d
Cleared
Feb 06, 2026
Atellica® IM TSH3-Ultra II (TSH3ULII)
Siemens Healthcare Diagnostics, Inc.
Chemistry
262d
Cleared
Feb 06, 2026
INTEGRE LIO
Quantel Medical
Ophthalmic
266d
Cleared
Feb 06, 2026
Aptiva APS IgA Reagent
Inova Diagnostics, Inc.
Immunology
410d
Cleared
Feb 05, 2026
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with...
Argon Medical Devices, Inc.
Cardiovascular
31d
Cleared
Feb 05, 2026
Primevision 3D
Dentsply Sirona
Radiology
57d
Cleared
Feb 05, 2026
SIGNA™ Sprint Select
Ge Medical Systems, LLC
Radiology
71d
Cleared
Feb 05, 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
Penumbra, Inc.
Cardiovascular
225d
Cleared
Feb 04, 2026
UltraScore™ Focused Force PTA Balloon
Bard Peripheral Vascular, Inc.
Cardiovascular
30d
Cleared
Feb 04, 2026
G7® Revision Acetabular System
Zimmer, Inc.
Orthopedic
169d
Cleared
Feb 04, 2026
Luna® Ti Interbody Fusion System
Spinal Elements, Inc.
Orthopedic
327d
Cleared
Feb 03, 2026
Dexcom G7 Continuous Glucose Monitoring (CGM) System
Dexcom, Inc.
Chemistry
71d
Cleared
Feb 03, 2026
SmartGuard Technology
Medtronic Minimed
Chemistry
71d
Cleared
Feb 03, 2026
T2 Alpha Femur Retrograde Nailing System
Stryker GmbH
Orthopedic
76d
Cleared
Feb 03, 2026
Explant Express
Applied Medical Technology, Inc.
General & Plastic Surgery
186d