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
117889–117912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1992
SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
K914886 · CGR
Serono-Baker Diagnostics, Inc.
Chemistry · 124d
Cleared Mar 02, 1992
SRI TESTOSTERONE ENZYME IMMUNOASSAY
K915164 · CDZ
Serono-Baker Diagnostics, Inc.
Chemistry · 109d
Cleared Mar 02, 1992
VERA PDS & VERA PDI
K915249 · EJH
Aalba Dent, Inc.
Dental · 108d
Cleared Mar 02, 1992
TSH CONTROL
K915325 · JJX
Polymedco, Inc.
Chemistry · 101d
Cleared Mar 02, 1992
INTERLOCKING TIBIAL NAILING SYSTEM
K915435 · HSB
Stryker Corp.
Orthopedic · 90d
Cleared Mar 02, 1992
IMMOBILE
K915565 · KGX
Tnt Moborg Intl. , Ltd.
General & Plastic Surgery · 81d
Cleared Mar 02, 1992
OPHTIMPLANT
K915630 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 76d
Cleared Mar 02, 1992
KERALLOY-D CAPS
K915654 · EJJ
Wilde-USA, Inc.
Dental · 75d
Cleared Mar 02, 1992
ACTH IRMA KIT II MITSUBISHI YUKA
K915727 · CKG
Mitsubishi Yuka America, Inc.
Chemistry · 73d
Cleared Mar 02, 1992
PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH
K915774 · FTM
Ethicon, Inc.
General & Plastic Surgery · 69d
Cleared Mar 02, 1992
PRISMA UNIVERSAL BOND(R) 3
K915830 · KLE
Dentsply Intl.
Dental · 63d
Cleared Mar 02, 1992
AUTOMIX DENTAL AMALGAMATOR
K915847 · EFD
Kerr Corporation (Danbury)
Dental · 67d
Cleared Mar 02, 1992
IMPROVED DENTAL CHAIR
K920016 · KLC
Den-Tal-Ez Mfg Co., Inc.
Dental · 60d
Cleared Mar 02, 1992
IMPROVED DENTAL OPERATING LIGHT
K920017 · KLC
Den-Tal-Ez Mfg Co., Inc.
Dental · 60d
Cleared Mar 02, 1992
MAGNI-CAM
K920069 · HJG
Innoventions, Inc.
Ophthalmic · 55d
Cleared Mar 02, 1992
TURBIQUANT
K920124 · DHR
Behring Diagnostics, Inc.
Immunology · 52d
Cleared Mar 02, 1992
QUICKIE P100
K920180 · ITI
Sunrise Medical Quickie Designs, Inc.
Physical Medicine · 48d
Cleared Mar 02, 1992
CEDIA DIGOXIN ASSAY (MODIFICATION)
K920214 · KXT
Microgenics Corp.
Toxicology · 46d
Cleared Mar 02, 1992
AMERLITE MAB FT4 ASSAY
K920247 · CEC
Eastman Kodak Company
Chemistry · 41d
Cleared Mar 02, 1992
CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY
K920270 · BXB
Sports Medical Synergy
Physical Medicine · 41d
Cleared Mar 02, 1992
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K920504 · CEP
Medix Biotech, Inc.
Chemistry · 26d
Cleared Mar 02, 1992
DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL
K920560 · EJS
Invoclar North America, Inc.
Dental · 25d
Cleared Mar 02, 1992
DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.
K920561 · EJH
Ivoclar North America, Inc.
Dental · 25d
Cleared Mar 02, 1992
ABBOTT QUICKSTART AMYLASE, #5AXX
K920583 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 21d