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
78289–78312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2001
MONOJECT SAFETY NEEDLE
K012736 · FMI
Tyco Healthcare
General Hospital · 70d
Cleared Oct 25, 2001
MACROPORE ENT RECONSTRUCTION FILM
K012769 · NHB
Macropore Biosurgery, Inc.
Ear, Nose, Throat · 69d
Cleared Oct 25, 2001
WINNER CM4 COMBINATION UNIT
K012848 · GZJ
Rich-Mar Corp.
Neurology · 63d
Cleared Oct 25, 2001
COLLATEK SHEET
K012995 · MGP
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 49d
Cleared Oct 25, 2001
COLLATEK FOAM
K012997 · MGP
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 49d
Cleared Oct 25, 2001
CERCON BASE
K013230 · EIH
Degussa - Ney Dental, Inc.
Dental · 28d
Cleared Oct 25, 2001
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · KLS
Bayer Corp.
Chemistry · 24d
Cleared Oct 24, 2001
EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188
K000741 · IPF
138 Medical Supplies, Inc.
Physical Medicine · 596d
Cleared Oct 24, 2001
EZ-ON CONDOM
K001974 · MOL
Mayer Laboratories
Obstetrics & Gynecology · 482d
Cleared Oct 24, 2001
LIFT VB SPINAL SYSTEM
K010930 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 210d
Cleared Oct 24, 2001
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
K011056 · QEW
Arrow Intl., Inc.
Cardiovascular · 201d
Cleared Oct 24, 2001
SECUREGUARD RETRACTABLE SAFETY SYRINGE
K012121 · MEG
Safegard Medical Products, Inc.
General Hospital · 110d
Cleared Oct 24, 2001
24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
K012143 · DRA
Medtronic Cardiac Surgical Products
Cardiovascular · 106d
Cleared Oct 24, 2001
CONFORM SHEETING, MODEL IGEL
K012419 · MDA
Implantech Associates, Inc.
General & Plastic Surgery · 86d
Cleared Oct 24, 2001
CAAS II QVA
K012475 · LLZ
Pie Medical Imaging BV
Radiology · 83d
Cleared Oct 24, 2001
MACHNET CAROTIDS COIL ARRAY ASSEMBLY
K012491 · MOS
Machnet BV
Radiology · 82d
Cleared Oct 24, 2001
PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
K012673 · DYH
Prime Dental Manufacturing, Inc.
Dental · 71d
Cleared Oct 24, 2001
C.T.M. MOBILITY SCOOTER MODEL # HS-320
K012791 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 65d
Cleared Oct 24, 2001
C.T.M. MOBITIY SCOOTER MODEL #HS-360
K012792 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 65d
Cleared Oct 24, 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY...
K012822 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 24, 2001
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · LGZ
Nxstage Medical, Inc.
General Hospital · 62d
Cleared Oct 24, 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820,...
K012864 · FCG
Boston Scientific Corp
Gastroenterology & Urology · 58d
Cleared Oct 24, 2001
XTERRA GT POWER WHEELCHAIR
K012909 · ITI
Invacare Corp.
Physical Medicine · 55d
Cleared Oct 24, 2001
COLLATEK POWDER
K012990 · KGN
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 48d