FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
11857–11880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2022
Konig Mogen Clamp
K212911 · HFX
Medline Industries, Inc.
Obstetrics & Gynecology · 431d
Cleared Nov 18, 2022
Auxilock GFS Mini, GFS II Large, and GFS Ultimate
K213018 · MBI
Auxein Medical Private Limited
Orthopedic · 424d
Cleared Nov 18, 2022
Polso Watch
K220351 · DQA
Chronisense Medical, Ltd.
Anesthesiology · 284d
Cleared Nov 18, 2022
COSY Cervicothoracic Occipital Rod-Screw System
K220658 · NKG
Signus Medizintechnik GmbH
Orthopedic · 256d
Cleared Nov 18, 2022
BriefCase
K221330 · QAS
Aidoc Medical , Ltd.
Radiology · 196d
Cleared Nov 18, 2022
FBCC Night Guard
K221369 · OBR
Fbcc, Inc.
Dental · 190d
Cleared Nov 18, 2022
Single-Use Flexible Cystoscope
K221580 · FAJ
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 170d
Cleared Nov 18, 2022
Single-Use Flexible Rhinolaryngoscope
K221581 · EOB
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 170d
Cleared Nov 18, 2022
SiOxD Wound Matrix
K222189 · QSZ
Sioxmed, LLC
General & Plastic Surgery · 119d
Cleared Nov 18, 2022
Calibrate LTX Interbody System
K222455 · MAX
Alphatec Spine, Inc.
Orthopedic · 95d
Cleared Nov 18, 2022
Hair Growth Device
K222477 · OAP
Dongguan Lescolton Medical Equipment...
General & Plastic Surgery · 94d
Cleared Nov 18, 2022
CODA™ Anterior Cervical Plate System
K222493 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 92d
Cleared Nov 18, 2022
Electromed SmartVest Airway Clearance System
K222496 · BYI
Electromed, Inc.
Anesthesiology · 92d
Cleared Nov 18, 2022
OCS Lung Donor Flush Set
K222535 · MSB
TransMedics, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 18, 2022
Facet Blood Lancets
K222539 · QRL
Facet Technologies, LLC
General & Plastic Surgery · 88d
Cleared Nov 18, 2022
MANTA Laser
K222701 · GEX
Squalus Med , Ltd.
General & Plastic Surgery · 72d
Cleared Nov 18, 2022
Opulent TiNbN Coated Knee
K222816 · JWH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 60d
Cleared Nov 18, 2022
Tailored-H Cervical Stand Alone System
K222903 · OVE
Bespoke Technologies, LLC
Orthopedic · 56d
Cleared Nov 18, 2022
Banded Face Mask
K223003 · FXX
Hubei Medlink Healthcare Co., Ltd.
General Hospital · 50d
Cleared Nov 18, 2022
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
K223124 · MQB
DRTECH Corporation
Radiology · 46d
Cleared Nov 18, 2022
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
K223246 · BZQ
Baxter Healthcare Corproration
Anesthesiology · 29d
Cleared Nov 18, 2022
CONTOUR® NEXT GEN Blood Glucose Monitoring System
K223293 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 23d
Cleared Nov 17, 2022
TFX-LT2000 Therapy Light
K211265 · PDZ
Toefx, Inc.
General & Plastic Surgery · 570d
Cleared Nov 17, 2022
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
K212910 · EFB
Shenzhen Carejoy Technology Co., Ltd.
Dental · 430d