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
28273–28296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2017
syngo Application Software
K170747 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Jun 09, 2017
Cardinal Health Non-Reinforced Surgical Gown
K170762 · FYA
Cardinal Health200, LLC
General Hospital · 88d
Cleared Jun 09, 2017
Diamondback 360 Peripheral Orbital Atherectomy System
K170792 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Jun 09, 2017
Wingman 14C Crossing Catheter
K170996 · DQY
Reflow Medical, Inc.
Cardiovascular · 67d
Cleared Jun 09, 2017
1717SGC_127um and 1717SGC_140um
K171419 · MQB
Rayence Co., Ltd.
Radiology · 25d
Cleared Jun 09, 2017
1717SCC_127um and 1717SCC_140um
K171420 · MQB
Rayence Co., Ltd.
Radiology · 25d
Cleared Jun 08, 2017
SYNTEC HUMERAL NAIL SYSTEM
K161327 · HSB
Syntec Scientific Corporation
Orthopedic · 392d
Cleared Jun 08, 2017
NEXA Negative Pressure Wound Therapy System
K162610 · OMP
Nexa Medical , Ltd.
General & Plastic Surgery · 262d
Cleared Jun 08, 2017
Vibrance Pelvic Trainer
K162689 · HIR
Bioinfinity (M) Sdn. Bhd.
Gastroenterology & Urology · 254d
Cleared Jun 08, 2017
INVISIKNOT Ankle Syndesmosis Repair Kit
K162996 · HTN
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Jun 08, 2017
UTF Stem, reduced, #0, #00
K163193 · LPH
United Orthopedic Corporation
Orthopedic · 205d
Cleared Jun 08, 2017
ASD Oral Appliances
K163580 · LRK
American Sleep Dentistry
Dental · 170d
Cleared Jun 08, 2017
Valiant Curing Light
K170101 · EBZ
Inter-Med/Vista Dental Products
Dental · 148d
Cleared Jun 08, 2017
Laser Peripherals, LLC Family of Bare Laser Fibers
K170366 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 122d
Cleared Jun 08, 2017
Sorin Connect
K170460 · DXJ
Sorin Group Deutschland GmbH
Cardiovascular · 113d
Cleared Jun 08, 2017
Novosyn Quick Absorbable Suture
K170661 · GAM
Aesculap, Inc.
General & Plastic Surgery · 97d
Cleared Jun 08, 2017
Continuous Single Culture -NX (CSCM-NX)
K170681 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 94d
Cleared Jun 08, 2017
Gentrix Surgical Matrix Thick
K170763 · FTM
Acell, Inc.
General & Plastic Surgery · 87d
Cleared Jun 08, 2017
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
K170821 · NKB
Choicespine, LP
Orthopedic · 80d
Cleared Jun 08, 2017
NuVasive CoRoent Small Interlock II System
K170961 · OVE
Nu Vasive, Incorporated
Orthopedic · 69d
Cleared Jun 08, 2017
Intraskan DC Plus
K170967 · EHD
Skanray Technologies Private Limited
Radiology · 69d
Cleared Jun 08, 2017
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
K171066 · GEI
Covidien, LLC
General & Plastic Surgery · 59d
Cleared Jun 08, 2017
Accuray Precision Treatment Planning System
K171086 · IYE
Accuray Incorporated
Radiology · 57d
Cleared Jun 08, 2017
Trifore(tm) Cervical Plating System
K171112 · KWQ
Neurostructures, Inc.
Orthopedic · 55d