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
12913–12936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2022
AquaA
K213507 · FIP
Fresenius Medical Care Rental...
Gastroenterology & Urology · 268d
Cleared Jul 27, 2022
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
K214007 · FRG
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 217d
Cleared Jul 27, 2022
AOK 95A Medical Mask (20200049)
K220876 · FXX
Aok Tooling Limited
General Hospital · 124d
Cleared Jul 27, 2022
Upper Arm Type Blood Pressure Monitor
K220886 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 121d
Cleared Jul 27, 2022
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound...
K220922 · PFO
Cochlear Americas
Ear, Nose, Throat · 118d
Cleared Jul 27, 2022
Real Intelligence Cori
K220958 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 117d
Cleared Jul 27, 2022
Hummingbird Tympanostomy Tube System
K221254 · ETD
Preceptis Medical, Inc.
Ear, Nose, Throat · 86d
Cleared Jul 27, 2022
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with...
K221269 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 86d
Cleared Jul 27, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with...
K221271 · LZA
Shandong Maida Medical Technology...
General Hospital · 86d
Cleared Jul 27, 2022
reVive Light Therapy LED Cleansing System
K221430 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 71d
Cleared Jul 27, 2022
CorPath GRX System
K221464 · DXX
Corindus, Inc.
Cardiovascular · 69d
Cleared Jul 27, 2022
Pegasus-X Expandable PLIF System
K221687 · MAX
GS Medical Co., Ltd.
Orthopedic · 47d
Cleared Jul 27, 2022
OTC DDR
K221853 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 30d
Cleared Jul 27, 2022
BIOMONITOR IIIm, BIOMONITOR III
K221856 · MXD
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jul 26, 2022
Gastric Lightguide (GLG)
K212407 · KNT
Naser Dib Gabinet Lekarksi Nasmed
Gastroenterology & Urology · 357d
Cleared Jul 26, 2022
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
K213858 · NXO
DiaSorin, Inc.
Immunology · 228d
Cleared Jul 26, 2022
Invia Ease Negative Pressure Wound Therapy (NPWT) System
K214112 · OMP
Medela AG
General & Plastic Surgery · 208d
Cleared Jul 26, 2022
Identity Imprint Knee Replacement System (including Identity Imprint...
K221404 · JWH
Conformis, Inc.
Orthopedic · 71d
Cleared Jul 26, 2022
Parcus Synd-EZ SS
K221502 · MBI
Parcus Medical, LLC
Orthopedic · 64d
Cleared Jul 26, 2022
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
K221567 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 56d
Cleared Jul 26, 2022
VyPlate Anterior Cervical Plate System
K221572 · KWQ
Vy Spine, LLC
Orthopedic · 55d
Cleared Jul 26, 2022
Cemented Round Patella with JRNY Pegs
K221939 · JWH
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Jul 25, 2022
Viz SDH
K220439 · QAS
Viz. Ai, Inc.
Radiology · 159d
Cleared Jul 25, 2022
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
K220606 · EOQ
Ambu A/S
Ear, Nose, Throat · 145d