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
80593–80616 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 20, 2000
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
K003621 · MHX
Agilent Technologies, Inc.
Cardiovascular · 26d
Cleared Dec 20, 2000
REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY...
K003624 · GEI
Arthrocare Corp.
General & Plastic Surgery · 26d
Cleared Dec 20, 2000
DW 273 #1
K003632 · EJS
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 20, 2000
DW 277 #4
K003633 · EJT
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 20, 2000
PLACEMENT-PLUS
K003642 · LJS
Catheter Innovations, Inc.
General Hospital · 23d
Cleared Dec 20, 2000
CONFORMANCE CHEMISTRY CONTROL C3
K003716 · JJY
Consolidated Technology
Chemistry · 19d
Cleared Dec 20, 2000
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K003728 · KWS
Tornier
Orthopedic · 16d
Cleared Dec 20, 2000
CHEMO-AIDE DISPENSING PIN
K003730 · LHI
Baxter Healthcare Corp
General Hospital · 16d
Cleared Dec 20, 2000
ELECSYS DHEA-S CALCHECK
K003772 · JJX
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Dec 20, 2000
COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
K003781 · GEX
Cooltouch Corp.
General & Plastic Surgery · 13d
Cleared Dec 19, 2000
MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
K000081 · JAQ
Isotopes and Metals , Ltd.
Radiology · 343d
Cleared Dec 19, 2000
APPRAISE URINE MICROALBUMIN COLLECTION KIT
K002156 · CGX
Osborn Group, Inc.
Chemistry · 155d
Cleared Dec 19, 2000
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K002393 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 134d
Cleared Dec 19, 2000
BAYER RAPIDPOINT 400 SYSTEM
K002738 · CHL
Bayer Corp.
Chemistry · 109d
Cleared Dec 19, 2000
GOLD CORE HF PRE SOLDER
K002815 · EJT
Jeneric/Pentron, Inc.
Dental · 99d