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
15337–15360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2021
FIX-C PEEK Anterior Cervical Interbody System
K212266 · ODP
Jeil Medical Corporation
Orthopedic · 154d
Cleared Dec 21, 2021
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with...
K212613 · LZA
Koon Seng Sdn Bhd
General Hospital · 125d
Cleared Dec 21, 2021
qXR-BT
K212690 · QIH
Qure.Ai Technologies
Radiology · 118d
Cleared Dec 21, 2021
BellaTek Encode Emergence Healing Abutments
K212730 · NHA
Biomet 3i, LLC
Dental · 113d
Cleared Dec 21, 2021
Vision
K212770 · PNN
Softsmile, Inc.
Dental · 112d
Cleared Dec 21, 2021
CT3000Pro
K212830 · FEN
Srs Medical
Gastroenterology & Urology · 105d
Cleared Dec 21, 2021
Vinyl Examination Gloves
K213006 · LYZ
Taian Hengchang Medical Technology...
General Hospital · 92d
Cleared CT Dec 21, 2021
TearCare System
K213045 · ORZ
Sight Sciences, Inc.
Ophthalmic · 90d
Cleared Dec 21, 2021
Restoration Modular 115mm Conical Distal Stem
K213129 · LZO
Howmedica Osteonics Corp., Dba...
Orthopedic · 85d
Cleared Dec 21, 2021
SURGmatic S15 L Pro
K213139 · EGS
Kavo Dental GmbH
Dental · 85d
Cleared Dec 21, 2021
InCore Subtalar System
K213301 · HWC
Nextremity Solutions, Inc.
Orthopedic · 81d
Cleared Dec 21, 2021
Xenco Medical Multilevel CerviKit
K213456 · KWQ
Xenco Medical, LLC
Orthopedic · 56d
Cleared Dec 21, 2021
OSSIOfiber Compression Screw, 3.5mm
K213596 · HWC
OSSIO , Ltd.
Orthopedic · 39d
Cleared Dec 21, 2021
DRSplus
K213705 · MYC
Centervue S.P.A.
Ophthalmic · 27d
Cleared Dec 20, 2021
Mpact® 3D Metal Implants - DMLS Technology
K202568 · LPH
Medacta International S.A.
Orthopedic · 472d
Cleared Dec 20, 2021
TCAT TKA Instrument Tray
K203468 · KCT
THINK Surgical, Inc.
General Hospital · 390d
Cleared Dec 20, 2021
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K203741 · JWY
Thermo Fisher Scientific
Microbiology · 363d
Cleared Dec 20, 2021
IPL Home Use Hair Removal Device
K211185 · OHT
Shenzhen Beauty Every Moment...
General & Plastic Surgery · 244d
Cleared Dec 20, 2021
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit:...
K211521 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 217d
Cleared Dec 20, 2021
Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
K211750 · FXX
National Bridge Industrial (S.Z.)...
General Hospital · 196d
Cleared Dec 20, 2021
Servator M SALF Solution
K211842 · KDL
S.A.L.F. Spa
Gastroenterology & Urology · 188d
Cleared Dec 20, 2021
AdVance XP Male Sling System
K211847 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 188d
Cleared Dec 20, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K211865 · LYZ
Liao Ning Shangwei Medical Products...
General Hospital · 187d
Cleared CT Dec 20, 2021
Frax 1940 for Nordlys and Frax Pro
K212492 · GEX
Candela Corporation
General & Plastic Surgery · 133d