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
80089–80112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 19, 2000
PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
K002942 · LLZ
Philips Medical Systems North...
Radiology · 89d
Cleared Dec 19, 2000
PRECISA BIOPSY NEEDLE
K002944 · FCG
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 89d
Cleared Dec 19, 2000
SILENT BIOPSY NEEDLE
K002946 · FCG
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 89d
Cleared Dec 19, 2000
BIOMOL ASPIRATION BIOPSY NEEDLE
K002947 · FCG
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 89d
Cleared Dec 19, 2000
NEURO II
K002964 · LNH
Innovative Magnetic Resonance Imaging...
Radiology · 88d
Cleared Dec 19, 2000
ACTIS ADJUSTABLE CONSTRICTION LOOP
K003115 · LKY
Vivus, Inc.
Gastroenterology & Urology · 78d
Cleared Dec 19, 2000
VARIANT II TOTAL GHB
K003280 · LCP
Bio-Rad
Hematology · 61d
Cleared Dec 19, 2000
PLASMAKINETIC ENDOUROLOGY SYSTEM
K003569 · KNS
Gyrus Medical , Ltd.
Gastroenterology & Urology · 29d
Cleared Dec 18, 2000
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441 · CGA
Lifescan, Inc.
Chemistry · 224d