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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75625–75648 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2002
APEX 800 LASER SYSTEM, MODEL APEX 800
K020849 · GEX
Iridex Corp
General & Plastic Surgery · 66d
Cleared May 20, 2002
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE,...
K020867 · KNW
Worldwide Medical Technologies, LLC
Gastroenterology & Urology · 63d
Cleared May 20, 2002
SERRALESTER
K020902 · GAT
Serral, S.A. DE C.V.
General & Plastic Surgery · 61d
Cleared May 20, 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025 · MQP
Implex Corp.
Orthopedic · 52d
Cleared May 20, 2002
ISOSEEDS I-125
K021343 · KXK
Bebig Isotopen-Und Medizintechnik GmbH
Radiology · 21d
Cleared May 17, 2002
INFANT PLETHYSMOGRAPH, MODEL 004400
K011344 · BZC
Collins Medical, Inc.
Anesthesiology · 380d
Cleared May 17, 2002
CARBON POST
K012496 · ELR
J. Morita USA, Inc.
Dental · 287d
Cleared May 17, 2002
VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES
K020113 · EBF
Vector Research & Development
Dental · 126d
Cleared May 17, 2002
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
K020747 · FLE
STERIS Corporation
General Hospital · 71d
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-URINE
K020799 · JHI
Quidel Corp.
Chemistry · 66d
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-COMBO
K020801 · JHI
Quidel Corp.
Chemistry · 66d
Cleared May 17, 2002
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
K020939 · LTT
Dade Microscan, Inc.
Microbiology · 56d
Cleared May 17, 2002
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
K021095 · MQX
Wujiang City Hua Xin Medical...
General Hospital · 43d
Cleared May 17, 2002
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED...
K021212 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 30d
Cleared May 17, 2002
SMARTWIRE/SMARTMAP PRESSURE SYSTEM
K021219 · DQX
Jomed, Inc.
Cardiovascular · 30d
Cleared May 17, 2002
Z3 GUIDE CATHETER
K021256 · DQY
Medtronic Vascular
Cardiovascular · 28d
Cleared May 17, 2002
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
K021274 · MEB
Baxter Healthcare Corp
General Hospital · 25d
Cleared May 17, 2002
SIMPLICITY EASY ACCESS P INFUSION SET
K021487 · FPA
Sterling Medivations, Inc.
General Hospital · 9d
Cleared May 16, 2002
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
K011726 · MQV
Millenium Biologix, Inc.
Orthopedic · 346d
Cleared May 16, 2002
MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
K013596 · JOZ
Accumetrics, Inc.
Hematology · 197d
Cleared May 16, 2002
IMMIX BONE GRAFT EXTENDER
K013764 · KKY
Osteogenics Biomedical, Inc.
General & Plastic Surgery · 184d
Cleared May 16, 2002
APATIGHT-TCP BONE GRAFT SUBSTITUTE
K013966 · MQV
Cerabio, LLC
Orthopedic · 164d
Cleared May 16, 2002
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
K014235 · DZE
Implant Innovations, Inc.
Dental · 141d
Cleared May 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
K020398 · LON
Dade Behring, Inc.
Microbiology · 99d