Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
41281–41304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2013
FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES
K123629 · KGO
Lucenxia Prescience AG
General Hospital · 171d
Cleared May 13, 2013
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
K123903 · MDB
Becton, Dickinson & CO
Microbiology · 145d
Cleared May 13, 2013
LATIS SPACER
K123913 · MAX
Globus Medical, Inc.
Orthopedic · 145d
Cleared May 13, 2013
CREO STABILIZATION SYSTEM
K124058 · OSH
Globus Medical, Inc.
Orthopedic · 133d
Cleared May 13, 2013
QLAB QUANTIFICATION SOFTWARE HEART MODEL
K130159 · LLZ
Philips Health Care
Radiology · 110d
Cleared May 13, 2013
REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
K130282 · KNW
Remington Medical, Inc.
Gastroenterology & Urology · 97d
Cleared May 13, 2013
IMSE P-TLIF
K130506 · MAX
Institute of Musculoskeletal Science...
Orthopedic · 75d
Cleared May 13, 2013
AG MASS
K131099 · JCX
Hospitech Respiration , Ltd.
General & Plastic Surgery · 24d
Cleared May 10, 2013
BOSTON KERATOPROSTHESIS OR BOSTON KPRO
K121203 · HQM
Massachusetts Eye & Ear Infirmary
Ophthalmic · 385d
Cleared May 10, 2013
EUROTROL HEMATOCRIT CONTROL
K121467 · GLK
Eurotrol B.V.
Hematology · 358d
Cleared May 10, 2013
SM TENS & PMS
K121719 · NGX
Hong Qiangxing (Shenzhen) Electronics...
Physical Medicine · 333d
Cleared May 10, 2013
HYPERION X9
K123381 · OAS
Cefla S.C.
Radiology · 190d
Cleared May 10, 2013
STINGRAY BIPOLAR FORCEPS
K123478 · GEI
Stingray Surgical Products
General & Plastic Surgery · 178d
Cleared May 10, 2013
ZX-I POWER ADD ON
K123769 · ITI
Spinergy, Inc.
Physical Medicine · 154d
Cleared May 10, 2013
FINGERTIP PULSE OXIMETER
K123871 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 144d
Cleared May 10, 2013
NEXTSTEP RETROGRADE
K130192 · MSD
Arrow International, Inc.
Gastroenterology & Urology · 105d
Cleared May 10, 2013
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
K130289 · HKI
Topcon Corp.
Ophthalmic · 94d
Cleared May 10, 2013
RAYSTATION
K130617 · MUJ
Raysearch Laboratories AB
Radiology · 64d
Cleared May 09, 2013
SAKURA STEAM STERILIZAER MODEL ASSV-AH06
K122774 · FLE
Sakura Seiki Co., Ltd.
General Hospital · 241d
Cleared May 09, 2013
NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT...
K123581 · DQA
Covidien, Formerly Nellcor Puritan...
Anesthesiology · 170d
Cleared May 09, 2013
UNITOX BOTOX SYRINGE
K123710 · FMF
Bio-Med USA, Inc.
General Hospital · 156d
Cleared May 09, 2013
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K130661 · PHX
Zimmer, Inc.
Orthopedic · 58d
Cleared May 09, 2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K130796 · MWI
Covidien
Cardiovascular · 48d
Cleared May 09, 2013
INTEGRA LAMINOPLASTY SYSTEM
K130830 · NQW
Seaspine, Inc.
Orthopedic · 44d