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
64681–64704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2005
STRYKER STILETTO ELECTROSURGICAL PROBE
K052141 · GEI
Stryker Endoscopy
General & Plastic Surgery · 59d
Cleared Oct 06, 2005
PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
K052436 · DWM
Denver Biomedical, Inc.
Anesthesiology · 30d
Cleared Oct 06, 2005
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
K052472 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Oct 06, 2005
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108
K052506 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 23d
Cleared Oct 06, 2005
LEADCARE II BLOOD LEAD TESTING SYSTEM
K052549 · DOF
Esa Biosciences, Inc.
Chemistry · 20d
Cleared Oct 06, 2005
START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)
K052681 · IOR
Otto Bock Healthcare LP
Physical Medicine · 8d
Cleared Oct 05, 2005
FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
K051176 · FAJ
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 152d
Cleared Oct 05, 2005
MED FLASH II INTENSE PULSED LIGHT SYSTEM.
K051508 · GEX
General Project S.R.L.
General & Plastic Surgery · 120d
Cleared Oct 05, 2005
CARDIOLINE AR 600, AR 1200, AR 2100
K051534 · DPS
Et Medical Devices Spa
Cardiovascular · 117d
Cleared Oct 05, 2005
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A,...
K051632 · MKJ
Philips Medical Systems
Cardiovascular · 107d
Cleared Oct 05, 2005
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
K051879 · FTM
Synthes (Usa)
General & Plastic Surgery · 86d
Cleared Oct 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML
K052270 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Oct 05, 2005
ETIAM STAR PACS COMPONENTS
K052358 · LLZ
Etiam, S.A.
Radiology · 37d
Cleared Oct 05, 2005
SCIENT'X CEMENT RESTRICTOR
K052367 · JDK
Scient'X
Orthopedic · 37d
Cleared Oct 05, 2005
YK9000 SERIES MANUAL WHEELCHAIR
K052468 · IOR
Intco Metal Products (Zhenjiang) Co.,...
Physical Medicine · 27d
Cleared Oct 05, 2005
SMARTSUCTION HARMONY DEVICE
K052626 · BTA
Haemonetics Corp.
General & Plastic Surgery · 12d
Cleared Oct 05, 2005
ARTHROCARE ARTHROWANDS
K052686 · GEI
Arthrocare Corp.
General & Plastic Surgery · 7d
Cleared Oct 04, 2005
MASTEL LASER CLEAN ROOM, MODEL EBS-100
K043494 · FYD
Mastel Precision Surgical...
General Hospital · 291d
Cleared Oct 04, 2005
POROUS COATED ACETABULAR COMPONENTS
K050124 · KWA
Biomet, Inc.
Orthopedic · 258d
Cleared Oct 04, 2005
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
K051514 · NBW
Hypoguard USA, Inc.
Chemistry · 118d
Cleared Oct 04, 2005
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
K051577 · LAF
Immunalysis Corporation
Toxicology · 112d
Cleared Oct 04, 2005
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
K051783 · FMI
Artsana S.P.A
General Hospital · 95d
Cleared Oct 04, 2005
SUREFLOW SAFETY INFUSION DEVICE
K051943 · FPA
Intrasafe Medical, LLC
General Hospital · 78d
Cleared Oct 04, 2005
HBA1C LINEARITY SET
K052010 · JJX
Cone Bioproducts
Chemistry · 71d