FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
27577–27600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2017
NuVasive® Growth Rod Conversion Set
K172979 · PGM
Nu Vasive, Incorporated
Orthopedic · 40d
Cleared Nov 03, 2017
Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle...
K170897 · PTI
B.Braun Medical, Inc.
General Hospital · 221d
Cleared Nov 03, 2017
Fingertip Pulse Oximeter
K170965 · DQA
Shenzhen Jumper Medical Equipment...
Anesthesiology · 217d
Cleared Nov 03, 2017
Reprocessed Halo XP Diagnostic Electrophysiology Catheter
K171788 · NLH
Innovative Health, LLC
Cardiovascular · 141d
Cleared Nov 03, 2017
Geistlich Wound Matrix
K171842 · KGN
Geistlich Pharma AG
General & Plastic Surgery · 136d
Cleared Nov 03, 2017
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100,...
K172045 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 120d
Cleared Nov 03, 2017
Materialise Glenoid Positioning System
K172054 · KWS
Materialise NV
Orthopedic · 120d
Cleared Nov 03, 2017
Capio SLIM Suture Capturing Device
K172060 · PWI
Boston Scientific Corporation
Obstetrics & Gynecology · 119d
Cleared Nov 03, 2017
Phlebo Press DVT Model
K172277 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 98d
Cleared Nov 03, 2017
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · DSA
Boston Scientific Corporation
Cardiovascular · 66d
Cleared Nov 03, 2017
CSMC Cardiac Suite
K172609 · KPS
Cedars-Sinai Medical Center
Radiology · 64d
Cleared Nov 03, 2017
PALLAS 308/311 Solid-State UV Laser System
K172639 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 63d
Cleared Nov 03, 2017
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with...
K172644 · GZB
Stimwave Technologies Incorporated
Neurology · 63d
Cleared Nov 03, 2017
Comet-PLUS
K172711 · OLV
Natus Medical Incorporated Dba...
Neurology · 56d
Cleared Nov 02, 2017
PixoTest Blood Glucose Monitoring System
K163087 · NBW
Ixensor Company , Ltd.
Chemistry · 364d
Cleared Nov 02, 2017
ORCA (tm) - Operational Rescue Containment Apparatus
K163223 · LGM
Isovac Products, LLC
General Hospital · 351d
Cleared Nov 02, 2017
VitalPatch® VitalConnect Platform
K163453 · DRG
Vitalconnect, Inc.
Cardiovascular · 328d
Cleared Nov 02, 2017
Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R)...
K163646 · FRC
Terragene S.A.
General Hospital · 314d
Cleared Nov 02, 2017
Neodent Implant System - CM Pro PEEK Abutment
K170080 · NHA
Jjgc Industria E Comercio DE...
Dental · 296d
Cleared Nov 02, 2017
Medussa-PL Cage
K170341 · MAX
Medyssey USA, Inc.
Orthopedic · 272d
Cleared Nov 02, 2017
BD Curve Ascites Shunt
K170405 · KPM
Care Fusion
Gastroenterology & Urology · 265d
Cleared Nov 02, 2017
BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
K170422 · FAD
Coloplast Corp.
Gastroenterology & Urology · 262d
Cleared Nov 02, 2017
InnoSpire Go
K170853 · CAF
Respironics Respiratory Drug Delivery...
Anesthesiology · 225d
Cleared Nov 02, 2017
DynaNail TTC Fusion System
K171376 · HSB
MedShape, Inc.
Orthopedic · 176d