Search FDA 510(k) Devices

5,437 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2022–2022 ×
3,212 results
1009–1032 of 3,212
Cleared Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2,...
K220134 · CFR
Roche Diagnostics
Chemistry · 241d
Cleared Sep 16, 2022
AllureTM Surgical Mask
K212926 · FXX
Allure Gift Wraps Private Limited
General Hospital · 367d
Cleared Sep 16, 2022
Tempo Smart Button
K212217 · QOG
Eli Lilly and Company
General Hospital · 427d
Cleared Sep 16, 2022
Altus Spine Pedicle Screw System
K211027 · NKB
Altus Partners, LLC
Orthopedic · 528d
Cleared Sep 16, 2022
Nexpowder
K202929 · QAU
Nextbiomedical Co., Ltd.
General & Plastic Surgery · 717d
Not Cleared Sep 16, 2022
Phagenyx System
DEN220025 · QQG
Phagenesis Limited
Ear, Nose, Throat · 150d
Cleared Sep 15, 2022
AIR OPTIX COLORS
K222500 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 28d
Cleared Sep 15, 2022
ArcTO Transobturator Sling System
K222468 · OTN
Urocure, LLC
Gastroenterology & Urology · 30d
Cleared Sep 15, 2022
StageOne™ Shoulder Cement Spacer Molds
K221968 · MBB
Biomet, Inc.
Orthopedic · 72d
Cleared Sep 15, 2022
Dynamic TiBase
K221966 · NHA
Talladium Espana, SL
Dental · 72d
Cleared Sep 15, 2022
NovoSorb Matrix
K221686 · QSZ
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 97d
Cleared Sep 15, 2022
CO2 Laser System
K221597 · GEX
Smedtrum Medical Technology Co., Ltd.
General & Plastic Surgery · 105d
Cleared Sep 15, 2022
Diamond Air+ (UI04A, UI04B, UI04C)
K221553 · OHT
Ulike Co., Ltd.
General & Plastic Surgery · 107d
Cleared Sep 15, 2022
P12 Elite Series Digital Color Doppler Ultrasound System
K221089 · IYN
Sonoscape Medical Corp.
Radiology · 155d
Cleared Sep 15, 2022
TrueBalance™ Surgical System
K220830 · ONN
These Three Medical, LLC
Orthopedic · 177d
Cleared Sep 15, 2022
Nitrile Patient Examination Gloves, Powder Free
K220697 · LZA
Lalan Rubbers (Pvt), Ltd.
General Hospital · 190d
Cleared Sep 15, 2022
Elecsys AFP
K220176 · LOJ
Roche Diagnostics
Immunology · 237d
Cleared Sep 15, 2022
Identity Shoulder System
K213856 · MBF
Zimmer, Inc.
Orthopedic · 279d
Cleared Sep 15, 2022
MONDRIAN ALIF Cage with Supplementary Fixation Plate
K213641 · MAX
Ctl Medical Corporation
Orthopedic · 301d
Cleared Sep 15, 2022
SafePort(TM) Manifold (or Stopcock)
K211204 · FMG
Elcam Medical Acal
General Hospital · 511d
Cleared Sep 15, 2022
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
K203336 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 672d
Cleared Sep 14, 2022
LightForce Orthodontic System
K222764 · NJM
Lightforce Orthodontics
Dental · 1d
Cleared Sep 14, 2022
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
K222503 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Sep 14, 2022
WatchPAT300 (WP300)
K222331 · MNR
Itamar Medical , Ltd.
Anesthesiology · 43d