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
82369–82392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2000
IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
K000574 · EGJ
Wr Medical Electronics Co.
Physical Medicine · 169d
Cleared Aug 09, 2000
GOLDFINGER DEVICE
K001162 · FMK
Mali-Tech , Ltd.
General & Plastic Surgery · 121d
Cleared Aug 09, 2000
KWIKKMODEL
K001414 · ELW
R-Dental Dentalerzeugnisse GmbH
Dental · 97d
Cleared Aug 09, 2000
QUINTON Q-STRESS, MODEL 000483
K001492 · DPS
Quinton, Inc.
Cardiovascular · 89d
Cleared Aug 09, 2000
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
K001727 · BSZ
Blease Medical Equipment , Ltd.
Anesthesiology · 64d
Cleared Aug 09, 2000
HOTLINE 2 FLUID WARMER
K001764 · LGZ
Sims Level 1, Inc.
General Hospital · 58d
Cleared Aug 09, 2000
MODIFICATION TO PASCO MIC AND MIC/ID PANELS
K001887 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Aug 09, 2000
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K002012 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 37d
Cleared Aug 09, 2000
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K002015 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 37d
Cleared Aug 09, 2000
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
K002116 · DTQ
Medical Device Consultants, Inc.
Cardiovascular · 27d
Cleared Aug 09, 2000
STOCKERT COMPACT SYSTEM VERSION 2.0
K002118 · DTQ
Stoeckert Instrumente
Cardiovascular · 27d
Cleared Aug 09, 2000
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
K002221 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 16d
Cleared Aug 09, 2000
TRUE
K993913 · LIT
Infinity Extrusion & Engineering, Inc.
Cardiovascular · 266d
Cleared Aug 08, 2000
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
K000388 · KPL
Clearwater Colon Hydrotherapy, Inc.
Gastroenterology & Urology · 183d
Cleared Aug 08, 2000
LA JOIE
K000736 · HED
Goomi Ehwa, Inc.
Obstetrics & Gynecology · 154d
Cleared Aug 08, 2000
GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES,...
K001404 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 97d
Cleared Aug 08, 2000
HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
K001406 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 97d
Cleared Aug 08, 2000
'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
K001978 · LTZ
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 40d
Cleared Aug 08, 2000
OR TABLE/MAGNETOM OPEN VIVA SYSTEM
K002225 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Aug 08, 2000
SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM
K002239 · IYN
Kontron Medical Systems Sas
Radiology · 15d
Cleared Aug 08, 2000
ULTRAGUIDE CT-GUIDE 1010
K002258 · JAK
Ultraguide , Ltd.
Radiology · 14d
Cleared Aug 07, 2000
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
K001126 · LDJ
Alatex Scientific, Inc.
Toxicology · 122d
Cleared Aug 07, 2000
CONSENSUS KNEE SYSTEM
K001456 · JWH
Hayes Medical, Inc.
Orthopedic · 90d
Cleared Aug 07, 2000
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
K001471 · LWJ
Implex Corp.
Orthopedic · 88d