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

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175,820 results
22105–22128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2019
3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure...
K191355 · FXX
3M Healthcare
General Hospital · 113d
Cleared Sep 11, 2019
Neocis Guidance System (NGS)
K191605 · PLV
Neocis, Inc.
Dental · 86d
Cleared Sep 11, 2019
TurboTemp EZ
K191619 · EBG
Zest Anchors, LLC
Dental · 85d
Cleared Sep 11, 2019
Catalyst OrthoScience CSR Shoulder System
K191811 · KWT
Catalyst Orthoscience, Inc.
Orthopedic · 68d
Cleared Sep 10, 2019
Pioneer Elite Diode Laser
K181602 · GEX
CAO Group, Inc.
General & Plastic Surgery · 448d
Cleared Sep 10, 2019
Sterling Supreme Diode Laser
K181614 · GEX
CAO Group, Inc.
General & Plastic Surgery · 448d
Cleared Sep 10, 2019
AI-Rad Companion (Cardiovascular)
K183268 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 291d
Cleared Sep 10, 2019
BH Medical Dental Barrier Sleeves and Barrier Film
K190484 · PEM
Bh Medical Products Co., Ltd.
General & Plastic Surgery · 195d
Cleared Sep 10, 2019
External Counterpulsation System
K190683 · DRN
Vamed Medical Instrument Co., Ltd.
Cardiovascular · 176d
Cleared Sep 10, 2019
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
K191013 · BZG
Welch Allyn, Inc.
Anesthesiology · 146d
Cleared Sep 10, 2019
KOWA nonmyd 8
K191945 · HKI
Kowa Company , Ltd.
Ophthalmic · 50d
Cleared Sep 09, 2019
Precise SHP Diode Laser
K181601 · GEX
CAO Group, Inc.
General & Plastic Surgery · 447d
Cleared Sep 09, 2019
Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT...
K183444 · LDS
Cenorin, LLC
General Hospital · 271d
Cleared Sep 09, 2019
Encompass 15 Channel Head Coil, 3T
K190668 · MOS
Qfix
Radiology · 178d
Cleared Sep 09, 2019
Ti3Z Cervical Interbody System
K191354 · ODP
Zavation Medical Products, LLC
Orthopedic · 111d
Cleared Sep 09, 2019
Sofacia System
K191421 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 104d
Cleared Sep 09, 2019
Connected OR Hub with Device and Voice Control
K192172 · GCJ
Stryker
General & Plastic Surgery · 28d
Cleared Sep 07, 2019
Focus TENS Therapy, Model PM710-M/-L
K183215 · NUH
Omron Healthcare, Inc.
Neurology · 292d
Cleared Sep 06, 2019
Klinly Ultrasonic Tongue Cleaner
K181986 · QIA
Kea Products, Ltd.
Dental · 408d
Cleared Sep 06, 2019
Secret RF Smartcure Applicator with electrodes
K182355 · GEI
Ilooda Co,., Ltd.
General & Plastic Surgery · 372d
Cleared Sep 06, 2019
Reusable Temperature Probe
K182751 · FLL
Shenzhen Caremed Medical Technology...
General Hospital · 343d
Cleared Sep 06, 2019
Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
K182886 · GKZ
Beckman Coulter
Immunology · 326d
Cleared Sep 06, 2019
Steerable catheter control system
K183027 · PJB
Stereotaxis, Inc.
Cardiovascular · 309d
Cleared Sep 06, 2019
Rhino-Laryngo Videoscope Olympus ENF-VT3
K183416 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 270d