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
12313–12336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2022
Sterile Hypodermic Needles for Single Use
K221066 · FMI
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use with Needles
K221068 · FMF
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use with Safety Needles
K221073 · MEG
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use
K221079 · FMF
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Safety Hypodermic Needles for Single Use
K221080 · FMI
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR...
K221517 · LPL
INTEROJO, Inc.
Ophthalmic · 132d
Cleared Oct 04, 2022
CD HORIZON™ ASTUTE™ SPINAL SYSTEM
K221646 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Oct 04, 2022
ROSA® Knee System
K221928 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 95d
Cleared Oct 04, 2022
Hailie Sensor NF0107 & NF0108
K221994 · CAF
Adherium (Nz), Ltd.
Anesthesiology · 90d
Cleared Oct 04, 2022
TriVerse Total Knee Replacement System
K222380 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 60d
Cleared Oct 04, 2022
Route 92 Medical Full Length 070 Access System
K222743 · QJP
Route 92 Medical, Inc.
Neurology · 25d
Cleared Oct 03, 2022
Velano Vascular Blood Collection Adapter 
K201237 · JKA
Velano Vascular
General Hospital · 879d
Cleared Oct 03, 2022
Aurolase Therapy, Laser Delivery Device (LDD)
K202953 · GEX
Nanospectra Biosciences, Inc.
General & Plastic Surgery · 733d
Cleared Oct 03, 2022
PCA Syringe Sets
K212262 · FPA
Baxter Healthcare Corporation
General Hospital · 440d
Cleared Oct 03, 2022
Varixis Elbow System
K213014 · HRS
Auxein Medical Private Limited
Orthopedic · 378d
Cleared Oct 03, 2022
ONVOY Acetabular System
K213842 · LPH
Globus Medical, Inc.
Orthopedic · 298d
Cleared Oct 03, 2022
Electronic Sphygmomanometer (Model: LT-P30)
K220220 · DXN
Zhuhai Linte Medical Instrument Co.,...
Cardiovascular · 250d
Cleared Oct 03, 2022
SILO TFX MIS Sacroiliac Joint Fixation System
K221047 · OUR
Aurora Spine, Inc.
Orthopedic · 178d
Cleared Oct 03, 2022
Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
K221613 · QRL
Owen Mumford, Ltd.
General & Plastic Surgery · 122d
Cleared Oct 03, 2022
Disposable Safety Lancets
K221778 · FMK
Suzhou Kyuan Medical Apparatus Co., Ltd.
General & Plastic Surgery · 104d
Cleared Oct 03, 2022
Arthrex 2.4 mm Volar Distal Radius Plate System
K222267 · HRS
Arthrex, Inc.
Orthopedic · 67d
Cleared Oct 03, 2022
Elastic Traction System
K222354 · QSW
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 60d
Cleared Oct 03, 2022
Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
K222376 · FMK
Shandong Lianfa Medical Plastic...
General & Plastic Surgery · 59d
Cleared Oct 01, 2022
Disposable Nitrile Examination Glove
K222937 · LZA
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 5d