FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80065–80088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 20, 2000
CRIT-LINE MONITOR III (CLM III)
K001763 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 191d
Cleared Dec 20, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210
K002308 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 145d
Cleared Dec 20, 2000
RDH BANDAGE
K002550 · KMF
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 125d
Cleared Dec 20, 2000
GOLD CORE POST SOLDER
K002854 · EJT
Jeneric/Pentron, Inc.
Dental · 100d
Cleared Dec 20, 2000
COOLBLU CURING LIGHT
K002925 · EBZ
Dental Systems.Com, Inc.
Dental · 92d
Cleared Dec 20, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K003100 · JCT
Boston Scientific Corp
General & Plastic Surgery · 78d
Cleared Dec 20, 2000
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
K003118 · DYG
Zcv ,Inc.
Cardiovascular · 76d
Cleared Dec 20, 2000
HAKIM PROGRAMMER AND TRANSMITTER
K003564 · JXG
Codman & Shurtleff, Inc.
Neurology · 30d
Cleared Dec 20, 2000
HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
K003565 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 30d