FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
106417–106440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 1994
ACE CEDIA CORTISOL ASSAY
K943427 · CGR
Schiapparelli Biosystems, Inc.
Chemistry · 136d
Cleared Nov 28, 1994
V-MAX OPTIONS
K943447 · JAA
Philips Medical Systems (Cleveland),...
Radiology · 133d
Cleared Nov 28, 1994
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM
K943595 · JJQ
Instrumentation Laboratory CO
Chemistry · 126d
Cleared Nov 28, 1994
CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS
K943722 · FMI
Baxter Healthcare Corp
General Hospital · 119d
Cleared Nov 28, 1994
SQUEEZE PLAY
K943730 · IRO
Conair Corp.
Physical Medicine · 118d
Cleared Nov 28, 1994
MONOGARD FACE SHIELD
K943809 · LYU
White Knight Healthcare
General Hospital · 116d
Cleared Nov 28, 1994
PRIMARY MONKEY KIDNEY CELL CULTURE
K943884 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
PRIMARY RABBIT KIDNEY CELL CULTURE
K943885 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
BGM CELL CULTURE
K943886 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
HUMAN NEWBORN FORESKIN CELL CULTURE
K943887 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
MDCK CELL CULTURE
K943888 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
VERO CELL CULTURE
K943889 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
WI38 CELL CULTURE
K943890 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
RD CULTURE CELL
K943891 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
SAUNDERS ELECTRONIC INCLINOMETER
K943898 · KQX
The Saunders Group
Neurology · 110d
Cleared Nov 28, 1994
RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE
K943926 · IZZ
Philips Medical Systems (Cleveland),...
Radiology · 108d
Cleared Nov 28, 1994
LATERALASE, MODIFIED
K944204 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 108d
Cleared Nov 28, 1994
ORIGIN TACKER SYSTEM
K944415 · OCW
Origin Medsystems, Inc.
Gastroenterology & Urology · 81d
Cleared Nov 28, 1994
POWER RECLINER
K944423 · ITI
Sunrise Medical, Inc.
Physical Medicine · 89d
Cleared Nov 28, 1994
TRUE/FLEX INTRAMEDULLARY ROD END-CAP
K944501 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 75d
Cleared Nov 28, 1994
P2 NITRILE EXAM GLOVES
K944514 · LYZ
Biosafety Systems, Inc.
General Hospital · 74d
Cleared Nov 28, 1994
GAMMA LOCKING NAIL - LONG LENGTH
K944883 · KTT
Howmedica Corp.
Orthopedic · 56d
Cleared Nov 28, 1994
NORELCO CLEAN AIR SYSTEM CAS900
K944927 · FRF
Norelco Consumer Products Co.
General Hospital · 53d
Cleared Nov 28, 1994
ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM
K945054 · GEX
Cytocare, Inc.
General & Plastic Surgery · 45d