FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12025–12048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2022
Perfit FS Dental Zirconia Fully Sintered Block
K222686 · EIH
Vatech Acucera, Inc.
Dental · 30d
Cleared Oct 06, 2022
Tibial baseplate, Tibial insert
K222700 · JWH
United Orthopedic Corporation
Orthopedic · 29d
Cleared Oct 05, 2022
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
K212779 · GJS
Coagusense, Inc.
Hematology · 399d
Cleared Oct 05, 2022
Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
K220138 · GEI
Led Spa
General & Plastic Surgery · 260d
Cleared Oct 05, 2022
ClearCorrect System
K220140 · NXC
Clearcorrect, LLC
Dental · 260d
Cleared Oct 05, 2022
Colibrí System
K220546 · LON
Copan Wasp Srl
Microbiology · 222d
Cleared Oct 05, 2022
Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
K221128 · MAI
Arthrex, Inc.
Orthopedic · 170d
Cleared Oct 05, 2022
Cornisol
K221759 · LYX
Aurolab
Ophthalmic · 110d
Cleared Oct 05, 2022
VISIONAIR
K221892 · BXQ
Pacificmd Biotech, LLC
Ear, Nose, Throat · 98d
Cleared Oct 05, 2022
FaSet Fixation System
K222515 · MRW
Dio Medical Corporation
Orthopedic · 47d
Cleared Oct 05, 2022
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
K222737 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 26d
Cleared Oct 04, 2022
HemosIL Liquid Anti-Xa
K213464 · KFF
Instrumentation Laboratory CO
Hematology · 341d
Cleared Oct 04, 2022
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
K220683 · QEW
Penumbra, Inc.
Cardiovascular · 210d
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