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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
66457–66480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2005
STRYKER MMF SCREW
K050535 · DZL
Stryker Instruments
Dental · 15d
Cleared Mar 17, 2005
GE DISCOVERY VCT SYSTEM
K050559 · KPS
GE Medical Systems
Radiology · 14d
Cleared Mar 16, 2005
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · KKX
Medline Industries, Inc.
General Hospital · 566d
Cleared Mar 16, 2005
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
K033436 · OWQ
Alliance Medical Corp.
Cardiovascular · 505d
Cleared Mar 16, 2005
COMPEL MLR SURGICAL GOWNS
K041541 · FYA
Standard Textile Co., Inc.
General Hospital · 281d
Cleared Mar 16, 2005
IMMUNOCARD STAT! FLU A & B
K041626 · PSZ
Meridian Bioscience, Inc.
Microbiology · 273d
Cleared Mar 16, 2005
EXCIA TOTAL HIP SYSTEM
K042344 · LWJ
Aesculap, Inc.
Orthopedic · 198d
Cleared Mar 16, 2005
ABILITY POWER GURNEY
K042699 · ITI
Gator Custom Mobility, Inc.
Physical Medicine · 167d
Cleared Mar 16, 2005
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
K042899 · HTO
Synthes (Usa)
Orthopedic · 147d
Cleared Mar 16, 2005
ENDOMARK STERILE INDIA INK
K042901 · NBG
Pmt Corp.
Gastroenterology & Urology · 147d
Cleared Mar 16, 2005
STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011,...
K043004 · FYA
Viasys Medsystems
General Hospital · 135d
Cleared Mar 16, 2005
STRYKER URETEROSCOPE
K043021 · FGB
Stryker Endoscopy
Gastroenterology & Urology · 133d
Cleared Mar 16, 2005
HEMOCATH
K043292 · MSD
Med-Conduit, Inc.
Gastroenterology & Urology · 107d
Cleared Mar 16, 2005
SPECTRANETICS LLD CS, MODEL 518-039
K043401 · DRB
Spectranetics Corp.
Cardiovascular · 96d
Cleared Mar 16, 2005
ENFANTTM
K043491 · GWE
Diopsys, Inc.
Neurology · 89d
Cleared Mar 16, 2005
TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)
K050091 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 61d
Cleared Mar 16, 2005
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
K050184 · KGO
Regent Medical Americas, LLC
General Hospital · 48d
Cleared Mar 16, 2005
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
K050214 · LZA
Hartalega Sdn Bhd
General Hospital · 44d
Cleared Mar 16, 2005
AEQUALIS REVERSED SHOULDER PROSTHESIS
K050316 · PHX
Tornier
Orthopedic · 35d
Cleared Mar 16, 2005
ULTRA MIRAGE II MASK
K050359 · BZD
Resmed, Ltd.
Anesthesiology · 30d
Cleared Mar 16, 2005
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING...
K050529 · LYY
Spi Gloves Sdn. Bhd.
General Hospital · 14d
Cleared Mar 16, 2005
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,...
K050530 · LZA
Spi Gloves Sdn. Bhd.
General Hospital · 14d
Cleared Mar 15, 2005
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K040883 · FEB
Advanced Sterilization Products
General Hospital · 344d
Cleared Mar 15, 2005
STRYKER FLEXIBLE CYSTONEPHROSCOPE
K043022 · FAJ
Stryker Endoscopy
Gastroenterology & Urology · 132d