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
73825–73848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2003
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356 · DXQ
Card Guard Scientific Survival , Ltd.
Cardiovascular · 101d
Cleared Jan 16, 2003
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS...
K023490 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 92d
Cleared Jan 16, 2003
PRE-POWDERED LATEX SURGEON'S GLOVES
K023515 · KGO
Sanrea Healthcare Private Limited
General Hospital · 87d
Cleared Jan 16, 2003
RADIONICS VARILINK 2
K023519 · IYE
Radionics, A Division of Tyco...
Radiology · 87d
Cleared Jan 16, 2003
GENZYME CONTRAST II HCG URINE/SERUM TEST
K023544 · JHI
Genzyme Corp.
Chemistry · 86d
Cleared Jan 16, 2003
ENCLOSE ANASTOMOSIS ASSIST DEVICE
K023682 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 76d
Cleared Jan 16, 2003
TEMPORARY CEMENT-DC010002
K023727 · EMA
GC America, Inc.
Dental · 71d
Cleared Jan 16, 2003
SKINTACT
K023920 · DRX
Leonhard Lang GmbH
Cardiovascular · 52d
Cleared Jan 16, 2003
REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE
K023952 · DZE
Nobel Biocare Uas, Inc.
Dental · 50d
Cleared Jan 16, 2003
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
K024200 · OWB
Ge Medical Systems, Inc.
Radiology · 27d
Cleared Jan 16, 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · DRX
Leonhard Lang GmbH
Cardiovascular · 24d
Cleared Jan 16, 2003
SKINTACT
K024264 · DRX
Leonhard Lang Co.
Cardiovascular · 24d
Cleared Jan 15, 2003
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
K021555 · DXX
Stereotaxis, Inc.
Cardiovascular · 247d
Cleared Jan 15, 2003
OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
K023289 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 105d
Cleared Jan 15, 2003
AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
K023482 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Jan 15, 2003
NUAMPS
K023536 · OLT
Neuroscan
Neurology · 86d
Cleared Jan 15, 2003
RHEUMATOID FACTOR (RF)
K024067 · DHR
Abbott Laboratories
Immunology · 36d
Cleared Jan 15, 2003
MODIFICATION TO TEMNO BIOPSY NEEDLES
K024120 · FCG
Allegiance Healthcare Corp.
Gastroenterology & Urology · 30d
Cleared Jan 15, 2003
MODIFICATION TO EBI XFIX DFS SYSTEM
K024129 · KTT
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 15, 2003
UNI HIP STEM
K024134 · LWJ
Plus Orthopedics
Orthopedic · 30d
Cleared Jan 15, 2003
JUPITER PROCESSING AND REVIEW WORKSTATION
K024137 · LLZ
Ge Medical Systems, Inc.
Radiology · 30d
Cleared Jan 15, 2003
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
K024161 · JWH
Implex Corp.
Orthopedic · 29d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
K024217 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219 · LKP
Bio-Rad
Immunology · 23d