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
28273–28296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2017
Duo Lumbar Interbody Fusion Device
K171660 · MAX
Spineology, Inc.
Orthopedic · 74d
Cleared Aug 18, 2017
Supria True64
K171738 · JAK
Hitachi Healthcare Americas Corporation
Radiology · 67d
Cleared Aug 18, 2017
EMBA Hourglass Peripheral Embolization Device
K171845 · KRD
Emba Medical Limited
Cardiovascular · 59d
Cleared Aug 18, 2017
Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With...
K171898 · KGO
Better Care Plastic Technology Co., Ltd.
General Hospital · 53d
Cleared Aug 18, 2017
Acclarix AX4 Diagnostic Ultrasound System
K171900 · IYN
Edan Instruments, Inc.
Radiology · 53d
Cleared Aug 18, 2017
Streamline OCT Occipito-Cervico-Thoracic System
K172139 · NKG
Pioneer Surgical Technology, Inc....
Orthopedic · 32d
Cleared Aug 18, 2017
QUANTIEN Measurement System
K172182 · DQK
St. Jude Medical (Now Part of the...
Cardiovascular · 30d
Cleared Aug 18, 2017
Connector System
K172194 · NKG
Orthofix, Inc.
Orthopedic · 28d
Cleared Aug 18, 2017
ACIST RXi Mini System
K172216 · DRQ
Acist Medical Systems, Inc.
Cardiovascular · 25d
Cleared Aug 18, 2017
UroLift System (UL500)
K172359 · PEW
Neotract, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 17, 2017
Allerhope Allergy Skin Tester
K162917 · SCL
Procare Industrial Co., Limited
General Hospital · 303d
Cleared Aug 17, 2017
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
K163321 · DWM
Rocket Medical Plc
Anesthesiology · 265d
Cleared Aug 17, 2017
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
K163339 · DPT
Spectralmd, Inc.
Cardiovascular · 262d
Cleared Aug 17, 2017
IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus...
K163500 · LHN
Ion Beam Applications S.A.
Radiology · 247d
Cleared Aug 17, 2017
Dentium NR Line CAD/CAM Abutments
K170384 · NHA
Dentium Co., Ltd.
Dental · 191d
Cleared Aug 17, 2017
Ureteral Dilators and Percutaneous Nephrostomy Dilators
K170531 · EZN
Coloplast Corp.
Gastroenterology & Urology · 176d
Cleared Aug 17, 2017
U Deliver Bolink ENFit Enteral Feeding Sets
K170555 · PIF
U Deliver Medical, LLC
Gastroenterology & Urology · 174d
Cleared Aug 17, 2017
ARIX Ankle Fibula Hook Plate System
K170979 · HRS
Jeil Medical Corporation
Orthopedic · 136d
Cleared Aug 17, 2017
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
K171028 · CCK
GE Healthcare Finland Oy
Anesthesiology · 134d
Cleared Aug 17, 2017
OMNI Anseris Hip Stem
K171156 · LZO
Omnilife Science
Orthopedic · 119d
Cleared Aug 17, 2017
DeRoyal Laprador Specimen Retrieval System
K171475 · GCJ
Deroyal Industries, Inc.
General & Plastic Surgery · 90d
Cleared Aug 17, 2017
Sequential Circulator SC-2004FC-OC
K171793 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 62d
Cleared Aug 17, 2017
Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
K171983 · KNS
Creo Medical, Ltd.
Gastroenterology & Urology · 48d
Cleared Aug 17, 2017
Zimmon Needle Knife Papillotome
K171993 · KNS
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 45d