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
24025–24048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 2019
Celerity HP Chemical Indicator (CI)
K183295 · JOJ
Steris Corporations
General Hospital · 38d
Cleared Jan 04, 2019
PicoLO Nd:YAG Picosecond Laser System
K183392 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 28d
Cleared Jan 03, 2019
Safe Secure Sterilization Pouches and Rolls
K180139 · FRG
Safe Secure Packing Co., Ltd.
General Hospital · 350d
Cleared Jan 03, 2019
Arm Blood Pressure Monitor
K180435 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 317d
Cleared Jan 03, 2019
Responsive Arthroscopy Suture Anchor System
K180951 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 267d
Cleared Jan 03, 2019
Maxcon Two Gallon Chemotherapy Container
K180983 · MMK
Ningbo Maxcon Medical Technology Co.,...
General Hospital · 265d
Cleared Jan 03, 2019
Maxcon Sharps Container
K180984 · MMK
Ningbo Maxcon Medical Technology Co.,...
General Hospital · 265d
Cleared Jan 03, 2019
EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor...
K181127 · PTE
Interscope, Inc.
Gastroenterology & Urology · 248d
Cleared Jan 03, 2019
V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature...
K182568 · MLR
STERIS Corporation
General Hospital · 107d
Cleared Jan 03, 2019
SculpSure
K182741 · PKT
Cynosure
General & Plastic Surgery · 97d
Cleared Jan 03, 2019
Cufitec Surgical Mask
K182766 · OUK
Nbc Meshtec, Inc.
General Hospital · 97d
Cleared Jan 03, 2019
uCT 520, uCT 528
K183143 · JAK
Shangai United Imaging Healthcare...
Radiology · 51d
Cleared Jan 03, 2019
Raven Lumbar Plate System
K183214 · KWQ
Choicespine, LP
Orthopedic · 45d
Cleared Jan 03, 2019
CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
K183294 · FRC
STERIS Corporation
General Hospital · 37d
Cleared Jan 03, 2019
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K183297 · FRG
STERIS Corporation
General Hospital · 37d
Cleared Jan 03, 2019
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological...
K183300 · FRC
Steris Corporations
General Hospital · 37d
Cleared Jan 03, 2019
PRO-LITE Sterilization Tray
K183301 · KCT
STERIS Corporation
General Hospital · 37d
Cleared Jan 03, 2019
Clear Image Aligners
K183643 · NXC
Specialty Appliance Works, Inc.
Dental · 8d
Cleared Jan 02, 2019
Infrared Thermometer
K181215 · FLL
Shenzhen Finicare Co., Ltd.
General Hospital · 240d
Cleared Jan 02, 2019
Raycell MK1
K181737 · MOT
Best Theratronics Limited
Radiology · 184d
Cleared Jan 02, 2019
Polaris RF Ablation System
K181864 · GXD
Baylis Medical Company, Inc.
Neurology · 174d
Cleared CT Jan 02, 2019
ClearUP Sinus Pain Relief
K182025 · GZJ
Tivic Health Systems, Inc.
Neurology · 156d
Cleared Jan 02, 2019
NFC-700 non-mydriatic auto fundus camera
K182199 · HKI
Crystalvue Medical Corporation
Ophthalmic · 141d
Cleared Jan 02, 2019
ProKnow DS
K182855 · LLZ
Proknow, LLC
Radiology · 84d