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
9193–9216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2023
X-Twist Biocomposite Suture Anchor
K232513 · MAI
Parcus Medical
Orthopedic · 31d
Cleared Sep 18, 2023
BTL-785BNF Handpiece
K232172 · NFO
BTL Industries, Inc.
Neurology · 59d
Cleared Sep 18, 2023
Access Myoglobin
K231832 · DDR
Beckman Coulter, Inc.
Chemistry · 88d
Cleared Sep 18, 2023
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
K231663 · LRK
Innovative Health Technologies (Nz),...
Dental · 103d
Cleared Sep 18, 2023
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201,...
K231367 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 130d
Cleared Sep 18, 2023
MA-40, MA-112
K223835 · FRF
Medify Air, LLC
General Hospital · 270d
Cleared Sep 18, 2023
B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA...
K222251 · QXS
B.R.A.H.M.S GmbH, Part of Thermo Fisher
Immunology · 418d
Cleared Sep 16, 2023
ImPACT Version 4
K231688 · POM
Impact Applications, Inc.
Neurology · 99d
Cleared Sep 16, 2023
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K230483 · CAH
Passy-Muir, Inc.
General Hospital · 205d
Cleared Sep 15, 2023
Barrier EasyWarm Active Self-Warming Blanket
K232508 · DWJ
Molnlycke Health Care Us, LLC
Cardiovascular · 28d
Cleared Sep 15, 2023
Catalyst Bone Void Filler
K232315 · MQV
Ossdsign AB
Orthopedic · 44d
Cleared Sep 15, 2023
Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS
K232199 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 52d
Cleared Sep 15, 2023
Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S...
K232198 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 52d
Cleared Sep 15, 2023
Power wheelchair (Model:BC-EA8000)
K232121 · ITI
Ningbo Baichen Medical Devices Co., Ltd.
Physical Medicine · 60d
Cleared Sep 15, 2023
ClearPoint Array System (Version 1.2)
K232102 · HAW
ClearPoint Neuro, Inc.
Neurology · 63d
Cleared Sep 15, 2023
BTI Dental Implant System UnicCa® – Aesthetic Post Abutments
K231827 · NHA
B.T.I. Biotechnology Institute, Sl.
Dental · 86d
Cleared Sep 15, 2023
PENTO Nd:YAG and Alexandrite laser system
K231791 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 87d
Cleared Sep 15, 2023
T2 Biothreat Panel
K231336 · QVR
T2biosystems, Inc.
Microbiology · 130d
Cleared Sep 15, 2023
Perifix FX Catheter
K231242 · BSO
B.Braun Medical, Inc.
Anesthesiology · 137d
Cleared Sep 15, 2023
LW UCLA Abutment
K231235 · NHA
Ossvis Co., Ltd.
Dental · 140d
Cleared Sep 15, 2023
NIDO™ Pedicle Screw System
K230974 · NKB
Kalitec Medical
Orthopedic · 163d
Cleared Sep 15, 2023
Accelerate Compression Screw System-Small Product Code ACC-S
K230946 · HWC
Trax Surgical
Orthopedic · 164d
Cleared Sep 15, 2023
Over-tube (TR-1208A)
K230752 · FED
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 182d
Cleared Sep 15, 2023
Ambu® aScope™ Colon
K230332 · FDF
Ambu A/S
Gastroenterology & Urology · 220d