FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80569–80592 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 21, 2000
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB,...
K003598 · DSP
Datascope Corp.
Cardiovascular · 30d
Cleared Dec 21, 2000
INTERACTIVE REAL TIME SCANNING PACKAGE
K003623 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 21, 2000
DW 272 #1
K003634 · EJT
Ivoclar North America, Inc.
Dental · 27d
Cleared Dec 21, 2000
BIO-LOGIC SLEEPSCAN NETLINK
K003681 · OLV
Bio-Logic Systems Corp.
Neurology · 21d
Cleared Dec 21, 2000
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE,...
K003724 · DTR
Medtronic Vascular
Cardiovascular · 17d
Cleared Dec 21, 2000
SERUM PROTEIN SUBSTITUTE
K003734 · MQL
Sage Biopharma
Obstetrics & Gynecology · 17d
Cleared Dec 21, 2000
CAPNO PROBE A
K984579 · CCK
Optical Sensors, Inc.
Anesthesiology · 729d
Cleared Dec 21, 2000
MSD EMBOLECTOMY BASKET
K991093 · QEW
Metamorphic Surgical Devices, LLC
Cardiovascular · 630d