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
14713–14736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 2022
EmbryoSlide+ ic8 dish
K213869 · MQK
Vitrolife A/S
Obstetrics & Gynecology · 88d
Cleared Mar 11, 2022
Demetra Dermatoscope BDEM-01
K213957 · PSN
Barco N.V.
General & Plastic Surgery · 84d
Cleared Mar 11, 2022
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
K220315 · MTJ
Orthocon, Inc.
Orthopedic · 36d
Cleared Mar 11, 2022
EndoGator Endoscopy Irrigation Tubing
K220395 · FEQ
STERIS Corporation
Gastroenterology & Urology · 28d
Cleared Mar 11, 2022
Dental sensors NanoPix1, NanoPix2
K220422 · MUH
Iray Technology Taicang , Ltd.
Radiology · 25d
Cleared Mar 11, 2022
MAGNETOM Vida, MAGNETOM Sola
K220425 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Mar 10, 2022
One Step Pregnancy Test
K210341 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 398d
Cleared Mar 10, 2022
D-Laser Blue, D-Laser 16
K210367 · NVK
Guilin Woodpecker Medical Instrument...
Dental · 395d
Cleared Mar 10, 2022
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy...
K211911 · LJE
Coloplast Corp.
Gastroenterology & Urology · 262d
Cleared Mar 10, 2022
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for...
K212148 · LZA
Ansell Healthcare Products, LLC
General Hospital · 244d
Cleared Mar 10, 2022
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
K212165 · PNE
Innovative Health, LLC
Cardiovascular · 241d
Cleared Mar 10, 2022
SIGNUS SACRONAIL® Transsacral Stabilization System
K212755 · HWC
Signus Medizintechnik GmbH
Orthopedic · 191d
Cleared Mar 10, 2022
Smile-100 System
K212965 · LHQ
Niramai Health Analytix Private Limited
Radiology · 175d
Cleared Mar 10, 2022
Infrared Forehead Thermometer, model: HS-9802D
K213038 · FLL
Jiaxing Shangjia Intelligence...
General Hospital · 170d
Cleared Mar 10, 2022
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with...
K213373 · LZA
Smart Glove Corporation Sdn. Bhd.
General Hospital · 149d
Cleared Mar 10, 2022
GLP systems Track
K213486 · JGS
Abbott Laboratories
Chemistry · 132d
Cleared Mar 10, 2022
ClearRead Xray Pneumothorax
K213566 · QFM
Riverain Technologies, Inc.
Radiology · 121d
Cleared Mar 10, 2022
NextAR™ TKA Platform My Knee PPS
K213751 · SBF
Medacta International S.A.
Orthopedic · 100d
Cleared Mar 10, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use with...
K213910 · LZC
Changzhou Universal Medical Equipment...
General Hospital · 85d
Cleared Mar 10, 2022
Hexa-Temp
K214071 · EBG
Spident Co., Ltd.
Dental · 73d
Cleared Mar 10, 2022
Sterilization Wraps
K220133 · FRG
Weihai Hongyu Nonwoven Fabric...
General Hospital · 51d
Cleared Mar 10, 2022
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K220361 · NZA
STERIS Corporation
General Hospital · 30d
Cleared Mar 09, 2022
Auto CPAP System
K211155 · BZD
BMC Medical Co., Ltd.
Anesthesiology · 324d
Cleared Mar 09, 2022
ZEN-2090 Turbo
K211780 · OWB
Genoray Co., Ltd.
Radiology · 273d