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
81169–81192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2000
MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
K003366 · MOS
Igc-Medical Advances, Inc.
Radiology · 53d
Cleared Dec 22, 2000
DW 276 #3
K003635 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared Dec 22, 2000
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
K003685 · MOS
Medical Advances, Inc.
Radiology · 22d
Cleared Dec 22, 2000
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II...
K003687 · DKE
Medtox Diagnostics, Inc.
Toxicology · 22d
Cleared Dec 22, 2000
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
K003769 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 16d
Cleared Dec 22, 2000
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000,...
K003790 · GCJ
Davol, Inc.
General & Plastic Surgery · 14d
Cleared Dec 22, 2000
GE ADVANCE NXI PET SYSTEM
K003849 · KPS
Ge Medical Systems, Inc.
Radiology · 10d
Cleared Dec 22, 2000
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K994279 · FIP
Pure Water Solutions, Inc.
Gastroenterology & Urology · 368d
Cleared Dec 21, 2000
VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD...
K000714 · FMI
Med-Pro Technologies, Inc.
General Hospital · 294d
Cleared Dec 21, 2000
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
K001634 · DXH
Tz Medical, Inc.
Cardiovascular · 209d
Cleared Dec 21, 2000
VECTOR
K002122 · ELC
Air Techniques, Inc.
Dental · 161d
Cleared Dec 21, 2000
MEDIADENT HDX/MMD HDX SP XRAY SENSOR
K002425 · MUH
Multi Media Dental Systems, Inc.
Radiology · 135d
Cleared Dec 21, 2000
RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
K002954 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Dec 21, 2000
EMPIRE N BLOOD PRESSURE MANOMETERS
K002955 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Dec 21, 2000
MAGNETIC CONCERTO
K003192 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Dec 21, 2000
SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000
K003243 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d
Cleared Dec 21, 2000
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
K003246 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d
Cleared Dec 21, 2000
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K003248 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d
Cleared Dec 21, 2000
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
K003264 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 64d
Cleared Dec 21, 2000
SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL...
K003277 · GDW
Powermed, Inc.
General & Plastic Surgery · 63d
Cleared Dec 21, 2000
HEM-O-LOK SMX, MODEL 544220
K003337 · FZP
Weck Closure Systems
General & Plastic Surgery · 57d
Cleared Dec 21, 2000
PUMP TUBING WITH X-COATING
K003371 · DWF
Terumo Corp.
Cardiovascular · 52d
Cleared Dec 21, 2000
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN...
K003545 · LYY
Terang Nusa Sdn Bhd
General Hospital · 34d
Cleared Dec 21, 2000
NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K003547 · LYY
Terang Nusa Sdn Bhd
General Hospital · 34d